(INUV) Plans Expansion Into a New Facility

(HOTR) to Present at the 2nd Annual Growth Capital Expo

(ORPN) Cabaletta in Oculopharyngeal Muscular Dystrophy Gets FDA Fast Track

TEL AVIV, Israel, April 9, 2015  — BioBlast Pharma Ltd. (Nasdaq:ORPN), a clinical-stage, orphan disease-focused biotechnology company announced today that the United States Food and Drug Administration (FDA) has granted Fast Track designation to Cabaletta for the treatment of patients with Oculopharyngeal Muscular Dystrophy (OPMD).

Cabaletta is being developed to treat OPMD, a rare and debilitating muscular dystrophy for which there is no cure or approved therapy. BioBlast is currently conducting a Phase 2/3 clinical study for OPMD and recently announced the granting of an IND, enabling the opening of a US clinical center in addition to the two ongoing clinical sites in Israel and Canada.

Established under the FDA Modernization Act of 1997, the Fast Track program is designed to facilitate the development and review of drugs intended to treat serious conditions and fill an unmet medical need. A drug development program with Fast Track designation is afforded greater access to the FDA for the purpose of expediting the drug’s development, review, and potential approval.

“We believe that the Fast Track designation represents an important recognition by the FDA of Cabaletta’s potential to address a significant unmet need in the treatment of OPMD patients,” stated Colin Foster, BioBlast’s President and Chief Executive Officer. “We will continue to work closely with the FDA with the goal of bringing Cabaletta to OPMD patients as quickly as possible,” he added.

About Cabaletta

Cabaletta is BioBlast’s proprietary intravenous (IV) solution of trehalose, a disaccharide, which has been shown to prevent pathological aggregation of proteins within cells in several diseases associated with abnormal cellular-protein aggregation as well as acting as an autophagy enhancer. Cabaletta has been documented as demonstrating significant efficacy in preclinical animal models of OPMD and other PolyA/PolyQ diseases.

About OPMD

OPMD is an inherited myopathy characterized by dysphagia (difficulty in swallowing) and the loss of muscle strength and weakness in multiple parts of the body. As the dysphagia becomes more severe, patients become malnourished, lose significant weight, become dehydrated and suffer from repeated incidents of aspiration pneumonia. Dehydration and aspiration pneumonia are often the cause of death. The disease is caused by a genetic mutation responsible for the creation of a mutant unstable protein (PABPN1) that aggregates within patient’s muscle cells.

About BioBlast

BioBlast Pharma is a clinical-stage biotechnology company committed to developing clinically meaningful therapies for patients with rare and ultra-rare genetic diseases. The company has a diverse portfolio of product candidates with the potential to address unmet medical needs for incurable genetic orphan diseases.

The BioBlast platforms are based on deep understanding of the disease-causing biological processes, and potentially offer solutions for several diseases that share the same biological pathology.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward looking statements when we discuss opening a new clinical center in the United States, making further progress toward providing a therapy to help OPMD patients, or that our platforms potentially address unmet medical needs and offer solutions for several diseases that share the same biological pathology. In addition, historic results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials would not suggest different conclusions or that historic results would not be interpreted differently in light of additional research and clinical and preclinical trials results. Because such statements deal with future events and are based on BioBlast Pharma Ltd.’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of BioBlast Pharma could differ materially from those described in or implied by the statements in this press release, including those discussed under the heading “Risk Factors” in BioBlast Pharma’s Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 31, 2015 and in any subsequent filings with the SEC. Except as otherwise required by law, BioBlast Pharma disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

CONTACT: U.S. Investor Contact:
         Michael Rice
         Founding Partner
         LifeSci Advisors, LLC
         646-597-6979

(NVGN) Australian Studies Confirm Anisina as Potential Important New Weapon Against Melanoma

– Anisina kills melanoma cells regardless of their mutation status – Melanoma cells with normal and mutated BRAF gene killed by Anisina – Anisina to come into the clinic as a new weapon against melanoma

SYDNEY, April 9, 2015  — US-Australian drug discovery company, Novogen (NRT:ASX; NVGN: NASDAQ), today announced that studies conducted at The University of Queensland Diamantina Institute (UQDI) revealed that experimental drug, Anisina, killed melanoma cells irrespective of their mutational status.

The significance of this finding lies in the fact that melanoma is associated with a variety of mutations, with those to the BRAF gene being the most prominent. A mutation to the BRAF gene occurs in about half of all melanoma patients and two drugs that target that mutation (vemurafenib and dabrafenib) have come to market in recent times. No targeted therapy exists for the 50% of melanoma patients whose tumors do not have the BRAF mutation. But even where a response is obtained with a BRAF-inhibitor, resistance typically develops within a year of treatment. Therefore the development of a drug that kills melanoma cells irrespective of their BRAF or any other mutational status has become an urgent clinical imperative.

Novogen believes that Anisina represents a significant potential opportunity to meet this need.

UQDI screened Anisina against a panel of melanoma cells obtained from patients and which represented the spectrum of mutations (BRAF, NRAS and c-KIT) commonly found in the community. Anisina was uniformly cytotoxic to the panel of cells, regardless of their mutational status. Importantly, Anisina showed a high level of specificity to cancer cells, with toxicity against normal melanocytes requiring a four-fold drug level.

Anisina is an anti-tropomyosin compound that targets the cytoskeleton of the cancer cells. It is being brought into the clinic for the treatment of cancers as a companion drug for the anti-mitotic family of drugs…the taxanes and vinca alkaloids. The rationale is that the use of Anisina (targeting the microfilaments) in combination with anti-mitotic drugs (targeting the microtubules), provide comprehensive destruction of the two key parts of the cancer cell’s skeleton resulting in a 20-fold increase in the anti-cancer effect of either drug family alone.

Anisina is being brought into the clinic in early-2016 for the treatment of solid cancers, with late-stage melanoma and prostate cancer in adults and neuroblastoma in children being three key target indications. The current results give strength to the aim of conducting a clinical study in patients with late-stage melanoma using a combined treatment of Anisina and vincristine.

Nikolas Haass MD PhD and Brian Gabrielli PhD conducted the research studies.

Dr Haass said, “These findings from the preliminary screen with Anisina are exciting. Finding a compound that is equally effective against a wide panel of melanoma cell types irrespective of the genetic background has been a long-held goal. The University of Queensland Diamantina Institute is pleased to be part of the effort to bring this new drug candidate into the clinic.”

Justine Stehn PhD, Novogen Anti-Tropomyosin Program Director, said, “Melanoma is a notoriously difficult cancer to treat. The standard first-line cytotoxic drugs such as the taxanes and vinca alkaloids have little anti-cancer effect.”

“But we see a 20-fold increase in the cancer killing effect of these drugs when combined with Anisina. We have demonstrated this combination effect with vincristine in prostate cancer cells, neuroblastoma cells, and now melanoma cells. The idea that we now have a means of making melanoma cells respond to potent anti-cancer drugs such as vincristine is an exciting development for patients with melanoma.”

Graham Kelly PhD, Novogen Group CEO, said, “These results support our belief that Anisina has the potential to become one of the most widely used anti-cancer drugs across the full spectrum of cancer. In conjunction with our clinical advisors, we have a clinical strategy laid out which we intend to prosecute all the way through to achieving regulatory approval.”

About Melanoma

The incidence of melanoma has doubled since 1973 and continues to increase, with countries such as Australia and New Zealand taking the lead with one of the highest rates of morbidity and mortality of melanoma. Around 12,500 new cases are diagnosed each year in Australia with malignant melanoma and it is responsible for over 1,500 deaths.  In the US, approximately 74,000 thousand cases of invasive melanoma are expected to be diagnosed, with 10,000 deaths. In the UK, malignant melanoma is the 5^th most common cancer.

There are limited therapeutic options for the treatment of metastatic melanoma as standard of care chemotherapy is ineffective against this highly resistant disease.

Melanomas are now “molecularly classified” based on the activating mutations in the MAP kinase pathway.  The most frequent mutations are activating oncogenic mutations in the BRAF gene. These mutations are present in 40-60% of malignant melanoma. There is a smaller subset of less common activating mutations which include: NRAS, which is found in approximately 15-20% of melanomas; c-KIT mutations, make up a smaller percentage of the mutation found in melanoma among the white population (6-7%) but are the most common mutation found in the Asian population; and CDK4 mutations which have been identified in in approximately 4% of melanomas.

Despite remarkable clinical responses to targeted therapies and to immunotherapies, relapse of the disease is common in the vast majority of patients. In addition, selectivity of these targeted inhibitors leaves greater than 50% of patients with inadequate treatment options. Therefore it is a clinical imperative that new therapeutic strategies be developed.

About Anisina

Anisina is a small molecule that belongs to a class of compounds known as anti-tropomyosins which target and destroy the microfilaments of cancer cells. Anisina binds to and inhibits the function of a core component of the microfilaments, tropomyosin Tpm3.1 (previously known as Tm5NM1). The role of Tpm 3.1 is to protect and stabilise the microfilaments of a cell. Inhibition of this protein by Anisina leads to the disassembly and collapse of the microfilaments resulting in cell death. Despite the target protein, Tpm3.1 being found in both normal and cancer cells, Anisina is significantly more effective against cancer cells as these cells rely more heavily on a functional Tpm3.1 for survival.

About Anti-Mitotic Drugs

Anti-mitotic drugs are drugs that block cell division (mitosis) by targeting the microtubule component of a cell’s cytoskeleton. Anti-microtubule drugs are the taxanes (paclitaxel, docetaxel, abraxane) and vinca alkaloids (vincristine, vinblastine and vinorelbine). These drugs remain among the most widely prescribed anti-cancer drugs after 35 years of use. Anti-mitotic drugs are standard of care for breast, prostate, lung, ovarian, colo-rectal, gastric and head and neck cancer, and many forms of leukaemia.

About The University of Queensland Diamantina Institute

UQDI is a modern research facility where clinical and basic science converge in the translational research of cancer, immunology and genomic medicine.

UQDI is host to more than 300 researchers, students and support staff. It lays claim to global, world-changing discoveries such as the world’s first cervical cancer vaccine.

Based at the Translational Research Institute (TRI) beside the Princess Alexandra Hospital, UQDI has strong clinical interactions and world-class facilities that enable researchers to be at the forefront of their fields. UQDI’s position within the TRI allows for a collaborative research environment, enabling researchers to focus their efforts on turning their scientific discoveries into better treatments for diseases.

About Novogen Limited

Novogen is a public, Australian-US drug-development company whose shares trade on both the Australian Securities Exchange (‘NRT’) and NASDAQ (‘NVGN’). The Novogen group includes US-based, CanTx Inc, a joint venture company with Yale University.

Novogen has two main drug technology platforms: super-benzopyrans (SBPs) and anti-tropomyosins (ATMs). SBP compounds have been designed to kill the full heterogeneity of cells within a tumor, but with particular activity against the cancer stem (tumor-initiating) cell.

The ATM compounds target the micro-filament component of the cancer cell’s cytoskeleton and have been designed to combine with anti-microtubule drugs (taxanes, vinca alkaloids) to produce comprehensive and fatal destruction of the cancer cell cytoskeleton.

The Company pipeline comprises two SBP drug candidates (TRXE-002, TRXE-009) and one ATM drug candidate (Anisina).

Further information is available on our website www.novogen.com

For more information please contact:

Forward-Looking Statements:

To the extent that statements contained in this press release are not descriptions of historical facts regarding Anisina, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this release include, among others, statements regarding the safety, efficacy and therapeutic potential of Anisina, the availability of data from clinical studies and our expectations regarding our research and development programs, expanding our pipeline and advancing our two drug technology platforms. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, working capital performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the conduct of future clinical studies, enrolment in clinical studies, availability of data from ongoing clinical studies and other matters that could affect the commercial potential of our drug candidates. Novogen undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Novogen in general, the reader is referred to filings made the U.S. Securities and Exchange Commission.

(TTOO) Study Published in Future Microbiology Reinforces T2Candida Panel for Sepsis

Study Showed Rapid Diagnosis of Candida, a Leading Cause of Sepsis, Significantly Reduces Patient Deaths and Hospital Costs Annually

LEXINGTON, Mass., April 8, 2015  — T2 Biosystems, Inc. (Nasdaq:TTOO), a company developing innovative diagnostic products to improve patient health, today announced that results from an analysis on the impact of using the company’s T2Candida^® Panel were published in Future Microbiology. The study, conducted by IMS Health, found that in a 500-bed hospital with an average of 5,100 symptomatic patients at high risk for developing a Candida infection, early detection with the utilization of T2Candida could provide an annual cost savings of approximately $5.8 million and the prevention of 60 percent of Candida-related deaths.

“We believe these data are extremely compelling and highlight the potentially meaningful benefits of early detection of Candida with our T2Candida Panel – including significantly reducing hospital costs, and more importantly, saving so many patient lives,” said John McDonough, chief executive officer of T2 Biosystems. “The findings from this study support our goal of changing the paradigm in sepsis diagnosis, and we look forward to the opportunity to help implement this important change for patients, physicians and hospital administrators.”

The study evaluated cost-effectiveness and the impact to hospital budgets using a decision tree model. The model calculated the economic effect of adopting a T2Candida diagnostic strategy over one year in a hospital setting. Key findings included:

• A typical 500 bed hospital with 5,100 annual high-risk patients could save as much as $5,858,448 annually. This reflects a cost savings of $1,149 per patient tested and a positive return on investment in less than one month.
• In all scenarios tested, even the most conservative, the T2Candida Panel delivered significant cost savings, with the lowest potential outcome being $4 million in savings.
• There were cost savings for patients who tested both positive and negative for Candida. Early detection allowed for timely, accurate treatment as necessary, and cost avoidance when not needed.
• Rapid detection avoided 31.7 patient deaths, or a reduction of 60.6 percent Candida-related deaths per hospital.

“Given the increasing demand for efficiency and improved outcomes in the hospital setting, it is critically important to understand the potential for a new product to both positively impact patient care, as well as budgets,” said Julie Munakata, senior principal at IMS Health. “At IMS, we perform many independent analyses and rarely do we see both cost savings and mortality prevention from new products.”

About The T2Candida Panel

The T2Candida Panel is the first sepsis pathogen diagnostic that provides species-specific results in three to five hours without the need for blood culture, which can take up to six days to provide a result. The rapid detection of Candida enables physicians to provide targeted treatment quickly, and research has shown this can reduce a positive sepsis patient’s length of stay in the hospital by almost nine days at a cost savings of approximately $26,887. A rapid negative result can prevent unnecessary administration of antimicrobials, further reducing costs. In addition, a rapid negative result can prevent or reduce antimicrobial resistance, which the Centers for Disease Control and Prevention has designated a serious threat.

About Candida

Candidemia is a systemic fungal infection that occurs when Candida organisms in the blood spread to organs and tissues throughout the body. Candidemia is the fourth leading hospital-acquired bloodstream infection and the most lethal form of common bloodstream infection that cause sepsis, according to the Center for Disease Control (CDC), with an approximate 40 percent mortality rate. In the absence of a rapid, accurate diagnostic, appropriate therapeutic intervention for candidemia is often delayed, resulting in a mortality rate that is three to four times higher than when early, targeted therapy is initiated. According to a study published in Antimicrobial Agents and Chemotherapy, the mortality rate can be reduced to 11 percent with the initiation of targeted therapy within 12 hours of presentation of symptoms. On average, candidemic patients require 40 days of hospitalization and have a hospital cost of $130,000.

About T2 Biosystems

T2 Biosystems is focused on developing innovative diagnostic products to improve patient health. With two FDA-cleared products targeting sepsis and a range of additional products in development, T2 Biosystems is an emerging leader in the field of in vitro diagnostics. The Company is utilizing its proprietary T2 Magnetic Resonance platform, or T2MR, to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables the fast and sensitive detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, eliminating the time-consuming sample prep required in current methods. For more information, please visit www.t2biosystems.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the performance of the Company’s diagnostic products and the ability to bring such products to market. These and other important factors discussed under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 4, 2015, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.

CONTACT: Media Contact:
         Katie Engleman, Pure Communications
         katie@purecommunicationsinc.com
         910-509-3977

         Investor Contact:
         Matt Clawson, Pure Communications
         matt@purecommunicationsinc.com
         949-370-8500

(EYES) Successful Implant of Model of Orion I Visual Cortical Prosthesis

SYLMAR, Calif., April 8, 2015  — Second Sight Medical Products, Inc. (Nasdaq:EYES) (“Second Sight” or “the Company”), a developer, manufacturer and marketer of implantable visual prosthetics to restore functional vision to blind patients, today announced the first successful implant of a mechanical model of the Orion™ I Visual Cortical Prosthesis (“Orion I”) in an animal study.

The first implant was performed as part of a phase I pre-clinical study, which is designed to evaluate fit, form, stability and biocompatibility. This study, which is expected to run through the end of the year, is the first major milestone in the Company’s development of the Orion I. Fully functional prototypes are expected to be completed later this year with active animal implants scheduled to begin by Q1 2016; the first human clinical trials are planned to commence by Q1 2017. Assuming positive initial results in patients and discussions with regulators, an expanded pivotal clinical trial for global market approvals is planned.

“This is a major milestone not only for the Company but, more importantly, those affected by virtually all forms of blindness,” said Robert Greenberg, M.D., Ph.D., President and CEO of Second Sight. “Following the success of Argus II in patients with Retinitis Pigmentosa, we are looking forward to extending the hope of restoring some useful vision to nearly all blind individuals with the Orion I.”

The Orion I technology is based on the FDA-approved Argus^® II Retinal Prosthesis System (“Argus II”), but with updates to the electrode neural interface — moving from the retina to the visual cortex. Implanted on the surface of the visual cortex located within the occipital lobe of the brain, Orion will bypass the retina and optic nerve altogether. This potentially offers hope for treating patients with nearly all forms of blindness where the optic nerve or retina is completely damaged, as in glaucoma, diabetic retinopathy, retinal detachments, trauma, infection, and others. The population of legally blind people potentially eligible for the Orion I is about 6 million worldwide.

About Second Sight

Second Sight’s mission is to develop, manufacture and market innovative implantable visual prosthetics to enable blind individuals to achieve greater independence. Second Sight has developed, and manufactures, the Argus^® II Retinal Prosthesis intended to provide some useful vision to individuals with outer-retinal degenerations such as Retinitis Pigmentosa (RP). U.S. Headquarters are in Sylmar, CA, and European Headquarters are in Lausanne, Switzerland. For more information, visit www.secondsight.com.

Safe Harbor

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange and Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. All statements in this release that are not based on historical fact are “forward looking statements”. While management has based any forward looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statement involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our recently filed registration statement on Form S-1. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

For Patient Inquiries:

Argus II hotline: 1 (855) 756-3703, or 1 (818) 833-5027, or patients@secondsight.com

CONTACT: Media Relations Contact:
         Allison Potter
         Pascale Communications, LLC
         T: 412-228-1678
         E: allison@pascalecommunications.com

         Investor Relations Contacts:
         Retail Investors
         MZ North America
         Matt Hayden, Chairman
         T: 949-259-4896
         E: matt.hayden@mzgroup.us
         www.mzgroup.us

         Institutional Investors
         In-Site Communications, Inc.
         Lisa Wilson, President
         T: 212-452-2793
         E: lwilson@insitecony.com

(INO) Selected by DARPA to Lead a $45 Million Program

Funding Will Accelerate Development of Inovio’s DNA-Based Monoclonal Antibodies That Could Offer Product Development, Manufacturing, Scale-Up and Dosing Benefits

PLYMOUTH MEETING, Pa., April 8, 2015  — Inovio Pharmaceuticals, Inc. (Nasdaq:INO) announced today that the company has been selected to receive a grant from the Defense Advanced Research Projects Agency (DARPA) to lead a collaborative team to develop multiple treatment and prevention approaches against Ebola. Inovio is the prime contractor on the DARPA program. Other collaborators are: MedImmune, the global biologics research and development arm of AstraZeneca; GeneOne Life Sciences (KSE:011000) and its manufacturing subsidiary, VGXI, Inc.; and Professor David B. Weiner, PhD, professor of Pathology and Laboratory Medicine at The Perelman School of Medicine at the University of Pennsylvania, Emory University and Vanderbilt University.

The Inovio-led consortium is taking a multi-faceted approach to develop products to prevent and treat Ebola infection. These programs include development and early clinical testing of:

• A therapeutic DNA-based monoclonal antibody product dMAb^™ against the Ebola virus infection. This promising new technology has properties that best fit a response to the outbreak in that they could be designed and manufactured expediently on a large scale using common fermentation technology, are thermal-stable, and may provide more rapid therapeutic benefit.
• A highly potent conventional protein-based therapeutic monoclonal antibody (mAb) product against Ebola virus infection.
• Inovio’s DNA-based vaccine against Ebola, with the first patient expected to be dosed in 2Q 2015. In previously published preclinical testing, Inovio’s DNA-based Ebola vaccine protected 100% of vaccinated animals from death and sickness after being exposed to a lethal dose of the Ebola virus.

Pathogen specific mAbs have emerged as a viable approach for immunoprophylaxis against Ebola and other pathogens where anti-viral drugs or vaccinations are not currently available. mAbs can be administered either just before or just after exposure to the pathogen and serve to combat the immediate effects of the pathogen. Unlike vaccines, immunoprophylaxis by mAbs does not develop long term immune memory. Therefore an ideal approach would include the administration of a mAb for immediate protection and a vaccine to train the immune system for longer term protection.

Previous Ebola research studies have shown that monoclonal antibodies (such as ZMapp) could be useful in treating patients who have been infected with Ebola virus by selectively binding and neutralizing the virus in the body. Inovio is already developing dMAb products against influenza and antibiotic resistant bacteria as a subcontractor under a separate DARPA funded grant.

The proposed effort will cover pre-clinical development costs for the dMAb products and protein mAb candidates as well as GMP manufacturing costs and the phase I clinical study costs with the three product candidates. MedImmune will manufacture the protein mAbs and the Inovio-GeneOne/VGXI team will manufacture the DNA based products. The academic partners are leading Ebola research and medical centers at the front edge of the discovery efforts for highly potent anti-Ebola mAbs. The funding period is over two years and covers a base award of $21 million and an option award of $24 million. The development proposal includes a second option of $11 million to support additional product supply and clinical development activities. The options are contingent upon the successful completion of certain pre-clinical development milestones.

Due to the global concerns and immediacy of need, the consortium has employed an aggressive development timeline for the Ebola products by developing these three options in parallel, resulting in an acceleration of the initial clinical evaluation. None of these products will contain any Ebola virus or viral particles.

Dr. J. Joseph Kim, President & CEO of Inovio, said, “We thank DARPA for their confidence in Inovio to address this medical crisis by simultaneously developing a preventive Ebola vaccine and treatment for those infected. We are advancing against this virus on all fronts. The development of the novel DNA-based monoclonal antibodies hold the greatest potential benefit in their speed of manufacturing, dosing and stability, and we are pleased to add them to our strong product pipeline.”

Dr. Niranjan Y. Sardesai, COO of Inovio and the DARPA Ebola Program Team Leader, said, “This is an exciting government–academia–industry partnership bringing together global product development experts to rapidly develop and test novel dMAb products against Ebola. Our optimized DNA based product programs are uniquely placed to target both rapid immunity through delivery of dMAb products as well as long-term immunity via DNA vaccination. Success in any one of the three parallel approaches by the team will be a boost to the global efforts against the Ebola virus.”

DARPA, an agency of the U.S. Department of Defense that creates and supports novel technologies important for national security, has selected Inovio to develop products that if successful can add to the arsenal of rapid response capabilities. Inovio’s Ebola program is initially targeted to treat first responders and Ebola-infected health care workers and patients, but could potentially be widely utilized to stem the spread of the current or subsequent outbreaks.

Inovio and the other participating institutions have a strong history of previous collaborative development efforts having worked together on multi-institutional product development grants and contracts bringing new products to the clinic. Inovio’s previous collaborative Ebola vaccine research efforts with GeneOne Life Sciences have been incorporated into this Inovio-led team.

About the Ebola Virus

The Ebola virus causes periodic outbreaks of a highly contagious and lethal human infectious disease marked by severe hemorrhagic fever, with a mortality rate that ranges between 50% and 90%. The infection typically affects multiple organs in the body and is often accompanied by severe bleeding. The virus is transmitted to people from wild animals and spreads in the human population through human-to-human transmission. At present, there are no FDA-approved pre- or post-exposure interventions available in the event of an outbreak, laboratory accident, or deliberate misuse. The Ebola virus is classified as a Category A Priority Pathogen by the Centers for Disease Control and Prevention. This designation prescribes an accelerated development pathway for FDA approval that determines efficacy based on two different validated animal studies followed by clinical evaluation in phase 1 and phase 2 trials to establish safety and immunogenicity for use in humans.

About Inovio Pharmaceuticals, Inc.

Inovio is revolutionizing the fight against cancer and infectious diseases. Our immunotherapies uniquely activate best-in-class immune responses to prevent and treat disease, and have shown clinically significant efficacy with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include Roche, MedImmune, University of Pennsylvania, DARPA, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.

This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines, our expectations regarding our research and development programs and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, including safety and efficacy for VGX-3100, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, our ability to support our broad pipeline of SynCon® active immune therapy and vaccine products, our ability to advance our portfolio of immune-oncology products independently, including INO-5150, and to commence a phase I clinical trial for INO-5150 in the first half of 2015, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, our ability to enter into partnerships in conjunction with our research and development programs, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company’s technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2014, and other regulatory filings from time to time. There can be no assurance that any product in Inovio’s pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.

CONTACT: Investors: Bernie Hertel, Inovio Pharmaceuticals
         858-410-3101, bhertel@inovio.com
         Media: Jeff Richardson, Inovio Pharmaceuticals
         267-440-4211, jrichardson@inovio.com

(ENTA) & (ABBV) Collab. Yields Results, Hep C Data To Be Shown At Liver Congress 2015

– 29 abstracts, including sub-analyses of AbbVie’s approved treatment of VIEKIRAX® + EXVIERA®, as well as new data from Phase 3b development program and AbbVie’s HCV pipeline compounds

NORTH CHICAGO, Ill., April 8, 2015  — AbbVie (NYSE: ABBV) today announced that 29 abstracts from its ongoing hepatitis C clinical development program have been accepted for presentation during The International Liver Congress^TM (ILC) 2015 in Vienna, Austria from April 22-26. Data being presented include sub-analyses of the recently approved VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets), Phase 3b studies, including a head-to-head comparison of AbbVie’s three direct-acting antiviral treatment with telaprevir-based therapy and Phase 2/3 studies investigating AbbVie’s combination treatment in genotype 1 (GT1) and genotype 4 (GT4). Additionally, data from Phase 1 studies of ABT-493 and ABT-530 will be presented.

“We are pleased to present new investigational data at ILC that reinforces our broad HCV clinical development program beyond the approval of VIEKIRAX + EXVIERA,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “We are studying the diverse populations seen in clinical practice and expanding our research and development, including our new HCV pipeline compounds.”

AbbVie’s ongoing HCV pipeline development program focuses on investigating a pan-genotypic, ribavirin (RBV)-free, once-daily treatment that may also allow for treatment durations of as little as eight weeks. Preliminary results from a Phase 2b study (n=79) of ABT-493 and ABT-530 in non-cirrhotic GT1 patients receiving the RBV-free recommended regimen for 12 weeks demonstrated a sustained virologic response rate at four weeks post treatment (SVR₄) of 99 percent (n=78/79). These results, announced for the first time today, included both GT1a and GT1b, treatment-naïve and pegylated-interferon and RBV prior null responders. Patients across both study arms were randomized to receive ABT-493 (200mg) and either 120mg or 40mg of ABT-530. To date, the most common (>5 percent) adverse reactions were fatigue, headache, nausea, diarrhea and anxiety. Data from these Phase 2b studies of ABT-493 and ABT-530 will not be presented at ILC 2015, and will be released at future medical congresses.

Abstracts for AbbVie’s HCV Pipeline Compounds:

• Pharmacokinetics of ABT-493 and ABT-530 is Similar in Healthy Caucasian, Chinese and Japanese Adult Subjects; Wang, T; ePoster # P0855
• Steady-state Pharmacokinetics and Safety of Co-administration of Pan-genotypic, Direct Acting Protease Inhibitor, ABT-493 with Pan-genotypic NS5A Inhibitor, ABT-530, in Healthy Adult Subjects; Lin, C; ePoster # P0715

Abstracts for Approved VIEKIRAX and EXVIERA:

• Long-Term Follow-up of Treatment-emergent Resistance-associated Variants in NS3, NS5A and NS5B with Paritaprevir/r-, Ombitasvir- and Dasabuvir-based Regimens; Krishnan, P; Oral Presentation, Viral Hepatitis C: Clinical Session, Friday, April 24 at 4:15pm–4:30pm CEST; # O057
• Implications of Baseline HCV RNA Level and Intrapatient Viral Load Variability on OBV/PTV/R + DSV 12-Weeks Treatment Outcomes; Brown, R; ePoster # LP39
• High SVR Rates Despite Multiple Negative Predictors in Genotype 1 Patients Receiving Ombitasvir/Paritaprevir/R, Dasabuvir with or without Ribavirin for 12 and 24 Weeks: Integrated Analysis of Six Phase 3 Trials; Bernstein, D; ePoster # P0781
• Pharmacokinetics of Paritaprevir, Ombitasvir, Ritonavir and Ribavirin in Subjects with HCV Genotype 4 Infection; Eckert, D; ePoster # P0823
• Improvement in Liver Function and Non-Invasive Estimates of Liver Fibrosis 48 Weeks After Treatment with Ombitasvir/Paritaprevir/R, Dasabuvir and Ribavirin in HCV Genotype 1 Patients with Cirrhosis; Wedemeyer, H; ePoster # P0808
• Pharmacokinetics of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir and Ribavirin in Subjects with HCV Genotype 1 Infection in Phase 3 Studies; Mensing, S; Khatri, A; ePoster # P0820
• Exposure-Response Analyses for Efficacy (SVR₁₂) for the Direct Acting Antiviral Regimen of ABT-450/R, Ombitasvir with Dasabuvir ± Ribavirin in Subjects with HCV Genotype 1 Infection; Khatri, A; ePoster # P0902
• Adherence to Ombitasvir/Paritaprevir/R, Dasabuvir, and Ribavirin is >98% in the SAPPHIRE-I and SAPPHIRE-II Trials; Hassanein, T; ePoster # P0908

Abstracts for Phase 3b Program:

• Safety of Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir for Treating HCV GT1 Infection in Patients with Severe Renal Impairment or End-stage Renal Disease: The RUBY-I Study; Pockros, P; Oral Presentation, Late Breakers Session, Saturday, April 25 at 4:00pm–4:15pm CEST
• MALACHITE-I: Phase 3b Trial of Ombitasvir/Paritaprevir/R and Dasabuvir+/-Ribavirin or Telaprevir + Peginterferon/Ribavirin in Treatment-Naïve Adults with HCV Genotype 1; Conway, B; ePoster # P0842
• MALACHITE-II: Phase 3b Trial of Ombitasvir/Paritaprevir/R and Dasabuvir + Ribavirin or Telaprevir + Peginterferon/Ribavirin in Peginterferon/Ribavirin Treatment-Experienced Adults with HCV Genotype 1; Dore, G; ePoster # P0847
• Phase 3b Studies to Assess Long-term Clinical Outcomes in HCV GT1-Infected Patients Treated with Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with or without Ribavirin; Dumas, E; ePoster # P1331

Abstracts for AbbVie’s HCV Investigational Treatment:

• Ombitasvir/Paritaprevir/Ritonavir for Treatment of HCV Genotype 1b in Japanese Patients with or without Cirrhosis: Results from GIFT-I; Sato, K; Rodrigues-Jr, L; Oral Presentation, General Session 3 & Award Ceremony 2: Saturday, April 25 at 8:30am–8:45am CEST; # G13
• A Randomized, Open-label Study to Evaluate Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir Co-administered with Ribavirin in Adults with Genotype 4 Chronic Hepatitis C Infection and Cirrhosis; Asselah, T; ePoster # P1345
• An Open-label Study to Evaluate the Efficacy and Safety of Co-formulated Ombitasvir/Paritaprevir/Ritonavir with Ribavirin in Adults with Chronic HCV Genotype 4 Infection in Egypt; Doss, W; ePoster # P1351
• No Significant Interaction Among Ombitasvir/Paritaprevir/Ritonavir ± Dasabuvir and Sofosbuvir; King, J; ePoster # P0905

Abstracts for Health Economics and Outcomes Research (HEOR) and Other AbbVie Data:

• The Public Health Value of Sparing Livers for Transplantation Through Systematic Treatment of Hepatitis C; Stevens, W; Juday, T; ePoster # P0025
• Healthcare Costs by Stage of Liver Disease in Chronic Hepatitis C Patients in the United States; Walker, D; ePoster # P0719
• The Value of Survival Benefits from Treating Hepatitis C at Different Fibrosis Stages with All-oral, Interferon-free Therapy Relative to ‘Watchful Waiting’; Gonzalez, Y; ePoster # P0806
• Cost-effectiveness of Treating Different Stages of Genotype 1 Hepatitis C Virus (HCV) with AbbVie 3D (ABT-450/Ritonavir/Ombitasvir and Dasabuvir) +/- Ribavirin Compared to No Treatment in the United States; Samp, J; ePoster # P0815
• Reduction in Annual Medical Costs with Early Treatment of HCV Using AbbVie 3D (ABT-450/Ritonavir/Ombitasvir and Dasabuvir) +/- Ribavirin in the United States; Samp, J; ePoster # P0816
• Percent of Subjects Experiencing Liver Morbidity Over A Lifetime Horizon with AbbVie 3D (ABT-450/Ritonavir/Ombitasvir And Dasabuvir) Versus No Treatment; Samp, J; ePoster # P0850
• Public Health Impact of HCV Screening and Treatment in the French Baby-boomer Population; Ethgen, O; ePoster # P1245
• Impact of Pill Count on Medication Adherence During the First 12 Weeks of HIV Antiviral Treatment: Implications for HCV Treatment; Walker, D; ePoster # P0741
• The Impact of Ribavirin on Real World Adherence and Discontinuation Rates in HCV Patients Treated with Sofosbuvir + Simeprevir; Walker, D; Juday, T; ePoster # P0864    
• Ombitasvir/Paritaprevir /Ritonavir and Dasabuvir with Ribavirin (RBV) has Minimal Impact on Health-Related Quality of Life (HRQoL) Compared with Placebo During 12-Week Treatment in Treatment-Naïve Adults with Chronic Hepatitis C (CHC); Liu, Y; ePoster # P0873
• Ombitasvir/Paritaprevir /Ritonavir and Dasabuvir with Ribavirin (RBV) has Mild Impact on Health-Related Quality of Life (HRQoL) Compared with Placebo During 12-Week Treatment in Treatment-Experienced Adults with Chronic Hepatitis C (CHC); Liu, Y; ePoster # P0856

The full ILC 2015 scientific program can be found at www.ilc-congress.eu/.

About VIEKIRAX® + EXVIERA®

VIEKIRAX + EXVIERA is approved in the European Union for the treatment of genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection.

VIEKIRAX consists of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily, and EXVIERA consists of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily taken with or without ribavirin, dosed twice daily. VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV, except in GT1a and GT4 patients with compensated cirrhosis, who should take it for 24 weeks.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie’s other investigational medicines for the treatment of chronic hepatitis C.

Additional information about AbbVie’s hepatitis C development program can be found on www.clinicaltrials.gov.

EU Indication

VIEKIRAX is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. EXVIERA is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.

Important EU Safety Information
Contraindications:

VIEKIRAX + EXVIERA are contraindicated in patients with severe hepatic impairment (Child-Pugh C). Patients taking ethinyl estradiol-containing medicinal products must discontinue them and switch to an alternative method of contraception prior to initiating VIEKIRAX + EXVIERA. Do not give VIEKIRAX with certain drugs that are sensitive CYP3A substrates or strong inhibitors of CYP3A. Do not give VIEKIRAX and EXVIERA with strong or moderate enzyme inducers. Do not give EXVIERA with certain drugs that are strong inhibitors of CYP2C8.

Special warnings and precautions for use:

VIEKIRAX and EXVIERA are not recommended as monotherapy and should be used in combination with other medicinal products for the treatment of hepatitis C infection.

Pregnancy and concomitant use with ribavirin
When VIEKIRAX + EXVIERA are used in combination with ribavirin, women of childbearing potential or their male partners must use an effective form of contraception during the treatment and 6 months after the treatment. Refer to the Summary of Product Characteristics for ribavirin for additional information.

ALT elevations
Transient elevations of ALT to >5x ULN without concomitant elevations of bilirubin occurred in clinical trials with VIEKIRAX + EXVIERA and were more frequent in a subgroup who were using ethinyl estradiol-containing contraceptives.

Use with concomitant medicinal products
Use caution when administering VIEKIRAX with fluticasone or other glucocorticoids that are metabolized by CYP3A4. A reduction in colchicine dosage or interruption in colchicine is recommended in patients with normal renal or hepatic function. VIEKIRAX with or without EXVIERA is expected to increase exposure of statins so certain statins need to be discontinued or dosages reduced. Low dose ritonavir, which is part of VIEKIRAX, may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy. HIV co-infected patients without suppressive antiretroviral therapy should not be treated with VIEKIRAX.

Adverse Reactions
Most common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with RBV were fatigue and nausea.

Full summary of product characteristics is available at www.ema.europa.eu.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie

AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. AbbVie employs more than 26,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” in AbbVie’s 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

(MYL) Proposes To Acquire (PRGO) For $205 Per Share

THIS ANNOUNCEMENT IS NOT AN ANNOUNCEMENT OF A FIRM INTENTION TO MAKE AN OFFER UNDER RULE 2.5 OF THE IRISH TAKEOVER PANEL ACT, 1997, TAKEOVER RULES 2013 AND THERE CAN BE NO CERTAINTY THAT AN OFFER WILL BE MADE, EVEN IF THE DUE DILIGENCE PRE-CONDITION IS SATISFIED OR WAIVED. Combination Would Create Global Pharmaceutical Leader with a Unique Profile and a Broad and Diverse Portfolio Across Branded, Generic and OTC Products; a Powerful Commercial Platform Reaching All Customer Channels; and an Exceptional, High Quality Operating Platform Cash-and-Stock Proposal Delivers Significant, Immediate Value to Perrigo Shareholders, Plus Participation in Long-Term Growth Opportunities Created by Combined Company Transaction to Generate Significant Operating Synergies, Expand Operating Margins and Result in Meaningful EPS Accretion

POTTERS BAR, England, April 8, 2015  — Mylan N.V. (NASDAQ: MYL) today announced that Mylan has made a proposal to acquire Perrigo Company plc (NYSE: PRGO) in a cash-and-stock transaction that would create a diversified, global pharmaceutical leader with an unmatched commercial and operating platform and a unique, one-of-a-kind profile. The combination of these highly complementary businesses would produce a company with critical mass in specialty brands, generics, over-the-counter (OTC) and nutritional products; a powerful commercial platform with reach across all customer channels; an exceptional high-quality operating platform; and opportunities to generate enhanced growth and deliver significant immediate and long-term value and benefits for shareholders and the other stakeholders of both companies.

Under the terms of the non-binding proposal, which was delivered to Perrigo’s Chairman on April 6, 2015, Perrigo shareholders would receive $205 in a combination of cash and Mylan stock for each Perrigo share, which represents a greater than 25% premium to the Perrigo trading price as of the close of business on Friday, April 3, 2015 (the last trading date prior to the date of Mylan’s proposal), a greater than 29% premium to Perrigo’s sixty-day average share price and a greater than 28% premium to Perrigo’s ninety-day average share price.

Mylan’s Executive Chairman Robert J. Coury commented, “This proposal is the culmination of a number of prior discussions between Mylan and Perrigo about the compelling strategic and financial logic of this combination. This combination would result in meaningful immediate and long-term value creation, and our proposal is designed to deliver that value to shareholders and other stakeholders of both companies.  We have great respect for Perrigo’s board and management team and what they have built.  We look forward in the weeks ahead to working with them to capitalize on this tremendous opportunity and working together to create a unique leader with a one-of-a-kind profile in our industry.”

The proposal is subject to the pre-condition of confirmatory due diligence, which pre-condition may be waived by Mylan at its discretion.  This announcement is not an announcement of a firm intention to make an offer under rule 2.5 of the Irish Takeover Panel Act, 1997, Takeover Rules 2013 and there can be no certainty that an offer will be made, even if the due diligence pre-condition is satisfied or waived. A further statement will be made if and when appropriate.

The full text of the letter delivered to Perrigo by Mylan on April 6, 2015 is included below.

April 6, 2015

Joseph C. Papa
President, Chief Executive Officer and Chairman
Perrigo Company plc
Treasury Building
Lower Grand Canal St.
Dublin 2, Ireland

Dear Joe:

As you and I have discussed on a number of occasions over the past few years, a combination of Mylan and Perrigo offers clear and compelling strategic and financial benefits, has sound industrial logic, and would create a global leader with a unique and one-of-a-kind profile.  We have complementary operations across all of our businesses, both from a product and geographic perspective.  In an environment where scale and reach are becoming increasingly important, the combination of our companies would result in an unmatched global platform, substantial revenue and operating synergies, and enhanced long-term growth potential, all of which would serve to create significant value for the combined company’s shareholders and other stakeholders.

Based on our many conversations over the years and my knowledge of Perrigo, I have often noted the similarity in the culture and core values of our two companies.  We both place paramount emphasis on integrity, respect and responsibility in our commitment to provide the world’s 7 billion people access to the broadest range of affordable, high quality medicine.  We also have a common focus on innovation, reliability and excellent customer service.  Most importantly, all of our people are dedicated to creating better health for a better world, one person at a time.  This shared culture and these common values will be key contributors to a successful integration.

For the foregoing reasons, I am writing on behalf of Mylan to propose a combination of Mylan and Perrigo in a transaction that would deliver to your shareholders significantly greater near-term and long-term value than they could otherwise obtain on a standalone basis.  Our proposal is the natural culmination of our prior discussions and reflects our shared vision for the industry.  This is the right time for our two companies to move forward together, and Mylan and our Board are firmly committed to making this combination a reality.

Specifically, we propose to offer Perrigo shareholders $205 in a combination of cash and Mylan stock for each Perrigo share, which represents a greater than 25% premium to the Perrigo trading price as of the close of business on Friday, April 3, 2015, a greater than 29% premium to Perrigo’s sixty-day average share price and a greater than 28% premium to Perrigo’s ninety-day average share price.

Our proposal provides a very significant cash payment to Perrigo shareholders.  In addition, even with conservative assumptions for what we believe to be significant and meaningful synergies coming from both companies, our proposal provides Perrigo shareholders with an even greater equity value in the combined company than they currently have in Perrigo today.

In addition to the compelling value to shareholders, a combination of Mylan and Perrigo would offer substantial benefits to the other stakeholders of both companies.  In particular, the combination would provide a broader variety of opportunities to our employees and increased stability for the communities in which we operate and serve.  The position of our creditors and suppliers would be enhanced by the combined company’s scale and significant free cash flows, and patients would receive improved access to affordable, high quality medicine through increased scale across geographies and robust capabilities to drive innovation.

As you and I have acknowledged in our prior discussions, we have no doubt that you and your Board will recognize the compelling logic of this transaction as outlined below:

• Highly complementary businesses with strong presence in key developed and emerging markets around the world;
• Attractive, diversified portfolio with critical mass across generics, OTC, specialty brands and nutritionals;
• Powerful commercial platform with strong reach across multiple channels, giving the combined company an increasingly important strategic advantage in light of the evolving distributor and payor dynamics across geographies;
• World-class operating platform, including an unrivaled combined manufacturing platform, renowned supply chain capabilities, vertical integration and global sourcing excellence with the cost advantages and flexibility to be a leading reliable source of high quality products around the world;  and
• Strong R&D capabilities, including broad technological capabilities across prescription, OTC and nutritionals products, and expertise in complex, difficult-to-formulate products, which would continue to expand our pipeline and drive long-term growth.

Our proposed transaction not only makes compelling strategic sense, it also results in a combined company with a very strong financial profile, including:

• Approximately $15.3 billion in 2014 pro forma sales;
• Substantial free cash flows driving rapid deleveraging and enhanced reinvestment into the business;
• Compelling synergies resulting in operating margin expansion and EPS accretion;
• Scope for meaningful revenue synergies given the strength of the combined business, rich pipeline of launches, and opportunities to mean more to our customers across business lines;
• A much stronger, larger and more diverse platform to create enhanced and more predictable earnings growth; and
• Greater opportunities for continued growth through strategic acquisitions.

Mylan is a seasoned integrator and quality operator, and we have extensive and proven experience in successfully integrating combinations like this one and capturing the significant value we see ahead.

We and our advisors have carefully studied the regulatory aspects of a combination of Mylan and Perrigo, and we are confident that we would be able to structure a transaction that would not pose material impediments to closing.

The Mylan Board would like to offer you the opportunity to serve with me as co-Chairman and as a member of the Mylan Board.  In addition, I look forward to discussing with you the possibility of potentially including other Perrigo directors on the Mylan Board.

The Mylan Board believes that continuity of our management team, with its successful track record of execution and proven strategic vision, is critical to the success of the combined company.  As such, I will continue to serve as Mylan’s Executive Chairman, Heather Bresch will continue to serve as CEO and Rajiv Malik will continue to serve as President.  Our Board also has great respect for your senior management team, and we envision the combined company leveraging the best of our collective management and employee talent.  To that end, we are hopeful that, among others at Perrigo, Judy Brown and Todd Kingma would be willing to serve in important roles with the combined company.  We also envision important roles in the combined company for members of Marc Coucke’s Omega Pharma management team.  We look forward to exploring with you other ways of maximizing the benefits to our shareholders and other stakeholders presented by combining these two very strong management teams.

We have dedicated a full team to the evaluation of Perrigo, including both Mylan management and outside advisors, and have conducted a thorough review of the business and its operations based on publicly available information.  In order to finalize our proposal, we would welcome the opportunity to complete customary confirmatory due diligence, which we believe could be completed quickly.  We stand ready to begin working with you and your team immediately and are prepared to commit the resources and time required to complete the proposed transaction expeditiously.  To that end, we have retained Goldman Sachs as financial advisors and Cravath, Swaine & Moore as legal advisors to assist us in completing this transaction.

This preliminary proposal is a non-binding indication of interest.

We look forward to working together with you to deliver compelling value and benefits to our respective shareholders and other stakeholders.

Very truly yours,

/s/ Robert J. Coury
Robert J. Coury
Executive Chairman

ABOUT MYLAN

Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of around 1,400 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in about 145 countries and territories. Our workforce of approximately 30,000 people is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com.

RESPONSIBILITY STATEMENT

The directors of Mylan accept responsibility for the information contained in this announcement. To the best of the knowledge and belief of the directors (who have taken all reasonable care to ensure that such is the case) the information contained in this announcement is in accordance with the facts and does not omit anything likely to affect the import of such information.

DEALING DISCLOSURE REQUIREMENTS

Under the provisions of Rule 8.3 of the Irish Takeover Panel Act, 1997, Takeover Rules 2013 (the “Irish Takeover Rules”), if any person is, or becomes, ‘interested’ (directly or indirectly) in, 1% or more of any class of ‘relevant securities’ of Perrigo or Mylan, all ‘dealings’ in any ‘relevant securities’ of Perrigo or Mylan (including by means of an option in respect of, or a derivative referenced to, any such ‘relevant securities’) must be publicly disclosed by not later than 3:30 pm (New York time) on the ‘business’ day following the date of the relevant transaction. This requirement will continue until the date on which the ‘offer period’ ends. If two or more persons co-operate on the basis of any agreement, either express or tacit, either oral or written, to acquire an ‘interest’ in ‘relevant securities’ of Perrigo or Mylan, they will be deemed to be a single person for the purpose of Rule 8.3 of the Irish Takeover Rules.

Under the provisions of Rule 8.1 of the Irish Takeover Rules, all ‘dealings’ in ‘relevant securities’ of Perrigo by Mylan or ‘relevant securities’ of Mylan by Perrigo, or by any party acting in concert with either of them, must also be disclosed by no later than 12 noon (New York time) on the ‘business’ day following the date of the relevant transaction.

A disclosure table, giving details of the companies in whose ‘relevant securities’ ‘dealings’ should be disclosed, can be found on the Irish Takeover Panel’s website at www.irishtakeoverpanel.ie.

Interests in securities arise, in summary, when a person has long economic exposure, whether conditional or absolute, to changes in the price of securities. In particular, a person will be treated as having an ‘interest’ by virtue of the ownership or control of securities, or by virtue of any option in respect of, or derivative referenced to, securities.

Terms in quotation marks are defined in the Irish Takeover Rules, which can also be found on the Irish Takeover Panel’s website. If you are in any doubt as to whether or not you are required to disclose a dealing under Rule 8, please consult the Irish Takeover Panel’s website at www.irishtakeoverpanel.ie or contact the Irish Takeover Panel on telephone number +353 1 678 9020 or fax number +353 1 678 9289.

Goldman Sachs, which is authorized by the Prudential Regulation Authority and regulated by the Financial Conduct Authority and the Prudential Regulation Authority in the United Kingdom, is acting for Mylan and no one else in connection with the proposed transaction and will not be responsible to anyone other than Mylan for providing the protections afforded to clients of Goldman Sachs, or for giving advice in connection with the proposed transaction or any matter referred to herein.

Goldman Sachs does not accept any responsibility whatsoever for the contents of this announcement or for any statement made or purported to be made by them or on their behalf in connection with the Offer. Goldman Sachs accordingly disclaims all and any liability whether arising in tort, contract or otherwise which it might otherwise have in respect of this announcement or any such statement.

ADDITIONAL INFORMATION

In connection with the proposal, Mylan expects to file certain materials with the Securities and Exchange Commission (the “SEC”), including, among other materials, a Registration Statement on Form S-4 and a proxy statement on Schedule 14A (in preliminary and then definitive form). This communication is not intended to be, and is not, a substitute for such filings or for any other document that Mylan may file with the SEC in connection with the proposal. INVESTORS AND SECURITYHOLDERS OF MYLAN AND PERRIGO ARE URGED TO READ THE DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY (IF AND WHEN THEY BECOME AVAILABLE) BEFORE MAKING AN INVESTMENT DECISION BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT MYLAN, PERRIGO AND THE PROPOSAL. Such documents will be available free of charge through the website maintained by the SEC at www.sec.gov or by directing a request to Mylan at 724-514-1813 or investor.relations@mylan.com. Any materials filed by Mylan with the SEC that are required to be mailed to shareholders of Perrigo and/or Mylan will also be mailed to such shareholders. This communication has been prepared in accordance with U.S. securities law, Irish law and the Irish Takeover Rules.

PARTICIPANTS IN SOLICITATION

This communication is not a solicitation of a proxy from any investor or shareholder. However, Mylan and certain of its directors, executive officers and other members of its management and employees may be deemed to be participants in the solicitation of proxies in connection with the proposal under the rules of the SEC. Information regarding Mylan’s directors and executive officers may be found in the Mylan proxy statement/prospectus on Form S-4 filed with the SEC on December 23, 2014 and Mylan Inc.’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014, which was filed with the SEC on March 2, 2015. These documents can be obtained free of charge from the sources indicated above. Additional information regarding the interests of these participants, which may, in some cases, be different than those of Mylan’s shareholders generally, will also be included in the materials that Mylan intends to file with the SEC when they become available.

NON-SOLICITATION

This communication is not intended to, and does not, constitute or form part of (1) any offer or invitation to purchase or otherwise acquire, subscribe for, tender, exchange, sell or otherwise dispose of any securities, (2) the solicitation of an offer or invitation to purchase or otherwise acquire, subscribe for, sell or otherwise dispose of any securities or (3) the solicitation of any vote or approval in any jurisdiction pursuant to this communication or otherwise, nor will there be any acquisition or disposition of the securities referred to in this communication in any jurisdiction in contravention of applicable law or regulation. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

FURTHER INFORMATION

The distribution of this communication in certain jurisdictions may be restricted or affected by the laws of such jurisdictions. Accordingly, copies of this communication are not being, and must not be, mailed or otherwise forwarded, distributed or sent in, into, or from any such jurisdiction. Therefore, persons who receive this communication (including, without limitation, nominees, trustees and custodians) and are subject to the laws of any such jurisdiction will need to inform themselves about, and observe, any applicable restrictions or requirements. Any failure to do so may constitute a violation of the securities laws of any such jurisdiction. To the fullest extent permitted by applicable law, Mylan disclaims any responsibility or liability for the violations of any such restrictions by any person.

FORWARD-LOOKING STATEMENTS

This communication contains “forward-looking statements.” These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include, without limitation, statements about the proposed transaction, benefits and synergies of the proposed transaction, future opportunities for Mylan, Perrigo, or the combined company and products and any other statements regarding Mylan’s, Perrigo’s, or the combined company’s future operations, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, competition and other expectations and targets for future periods. These may often be identified by the use of words such as “will”, “may”, “could”, “should”, “would”, “project”, “believe”, “anticipate”, “expect”, “plan”, “estimate”, “forecast”, “potential”, “intend”, “continue”, “target” and variations of these words or comparable words. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: uncertainties as to the timing of the proposed transaction; uncertainties as to whether Perrigo will cooperate with Mylan and whether Mylan will be able to consummate the proposed transaction; uncertainties as to whether shareholders will provide the requisite approvals for the proposed transaction; the possibility that competing offers will be made; the possibility that certain conditions to the consummation of the proposed transaction will not be satisfied; the possibility that Mylan will be unable to obtain regulatory approvals for the proposed transaction or be required, as a condition to obtaining regulatory approvals, to accept conditions that could reduce the anticipated benefits of the proposed transaction; the ability to meet expectations regarding the accounting and tax treatments of the proposed transaction, changes in relevant tax and other laws, including but not limited to changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; the integration of Perrigo being more difficult, time-consuming or costly than expected; operating costs, customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers, clients or suppliers) being greater than expected following the proposed transaction; the retention of certain key employees of Perrigo being difficult; the possibility that Mylan may be unable to achieve expected synergies and operating efficiencies in connection with the proposed transaction within the expected time-frames or at all and to successfully integrate Perrigo; expected or targeted future financial and operating performance and results; the capacity to bring new products to market, including but not limited to where Mylan uses its business judgment and decides to manufacture, market and/or sell products, directly or through third parties, notwithstanding the fact that allegations of patent infringement(s) have not been finally resolved by the courts (i.e., an “at-risk launch”); success of clinical trials and Mylan’s ability to execute on new product opportunities; the scope, timing and outcome of any ongoing legal proceedings and the impact of any such proceedings on financial condition, results of operations and/or cash flows; the ability to protect intellectual property and preserve intellectual property rights; the effect of any changes in customer and supplier relationships and customer purchasing patterns; the ability to attract and retain key personnel; changes in third-party relationships; the impact of competition; changes in the economic and financial conditions of the businesses of Mylan, Perrigo, or the combined company; the inherent challenges, risks, and costs in identifying, acquiring and integrating complementary or strategic acquisitions of other companies, products or assets and in achieving anticipated synergies; uncertainties and matters beyond the control of management; and inherent uncertainties involved in the estimates and judgments used in the preparation of financial statements, and the providing of estimates of financial measures, in accordance with GAAP and related standards or on an adjusted basis. For more detailed information on the risks and uncertainties associated with Mylan’s business activities, see the risks described in Mylan Inc.’s Annual Report on Form 10-K for the year ended December 31, 2014 and our other filings with the SEC. You can access Mylan’s filings with the SEC through the SEC website at www.sec.gov, and Mylan strongly encourages you to do so. Mylan undertakes no obligation to update any statements herein for revisions or changes after the date of this release, except as required by law.

NO PROFIT FORECAST / ASSET VALUATIONS

No statement in this announcement is intended to constitute a profit forecast for any period, nor should any statements be interpreted to mean that earnings or earnings per share will necessarily be greater or lesser than those for the relevant preceding financial periods for Mylan or Perrigo as appropriate. No statement in this announcement constitutes an asset valuation.

SOURCES AND BASES OF INFORMATION

The historical share price information for Perrigo is sourced from the New York Stock Exchange.

For the purposes of determining the premium described above, Perrigo’s share price as of close of business on Friday, April 3, 2015 ($163.73) has been used. For the purposes of determining the premium relative to Perrigo’s sixty-day average share price, Perrigo’s sixty-day average share price as of close of business on Friday, April 3, 2015 ($158.71) has been been used.  For the purposes of determining the premium relative to Perrigo’s ninety-day average share price, Perrigo’s ninety-day average share price as of close of business on Friday, April 3, 2015 ($159.64) has been used.

The information regarding pro forma 2014 revenues for Mylan and Perrigo combined is extracted from: (i) for information relating to Mylan, Mylan N.V.’s Amended Current Report (Form 8-K/A) filed with the SEC on March 26, 2015; (ii) for information relating to Perrigo, Perrigo’s Quarterly Report (Form 10-Q) for the period ended December 27, 2014 filed with the SEC on February 5, 2015, Perrigo’s Annual Report (Form 10-K) for the period ended June 28, 2014 filed with the SEC on August 14, 2014 and Perrigo’s press release announcing the completion of the acquisition of Omega Pharma Invest N.V. published on March 30, 2015.

The information set forth under “About Mylan” above has been extracted from Mylan Inc.’s Annual Report (Form 10-K) for the period ended December 31, 2014 filed with the SEC on March 2, 2015.

(ADXS) & (MRK) Team Up For Prostate Cancer Immunotherapy Clinical Trials

KEYNOTE-046 is the Second Trial Initiated to Evaluate KEYTRUDA, and the First-in-Human Study of ADXS-PSA, for Prostate Cancer

PRINCETON, N.J. and KENILWORTH, N.J., April 8, 2015  — Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, and Merck (NYSE:MRK), known as MSD outside the U.S. and Canada, announced that enrollment has initiated in the Phase 1/2 clinical trial evaluating the combination of ADXS-PSA (ADXS31-142), an investigational Lm-LLO immunotherapy, and KEYTRUDA^® (pembrolizumab), the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States, in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC). The clinical trial, KEYNOTE-046, is the first-in-human study of Advaxis’s lead Lm-LLO immunotherapy candidate for prostate cancer. It is the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer.

ADXS-PSA and KEYTRUDA are members of a class of cancer treatments known as immuno-oncology therapies. Data from preclinical studies suggest that Advaxis Lm-LLO immunotherapies in combination with a PD-1 antibody may lead to an enhanced anti-tumor immune response. The results from KEYNOTE-046 will determine the future clinical development program for the combination.

“A synergistic anti-tumor immune response has been observed in preclinical studies evaluating the combination of a PD-1 antibody with an Lm-LLO immunotherapy, and we look forward to the possibility of seeing these results in patients. This immunotherapy combination could be a promising alternative treatment option to current standards of care,” said Naomi B. Hass, M.D., Associated Professor of Medicine and Director of the Prostate and Kidney Cancer Program at the University of Pennsylvania Abramson Cancer Center and principal investigator for KEYNOTE-046.

“The KEYNOTE-046 combination immunotherapy study is a significant clinical development milestone for our Lm-LLO immunotherapy platform, as well as the advancement of ADXS-PSA as a potential treatment for advanced prostate cancer,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. “Further, for Advaxis, the initiation of this clinical program continues what has been a rapid progression of our pipeline, which we hope will further demonstrate the value of our immunotherapy technology alone and in combination with checkpoint inhibitors.”

“The initiation of new combination studies with KEYTRUDA is an example of our focus on advancing breakthrough science in the field of immuno-oncology,” said Eric Rubin, M.D., vice president and therapeutic area head, early-stage oncology development, Merck Research Laboratories. “We are pleased this study with Advaxis has begun and we look forward to gaining a better understanding of the potential of KEYTRUDA and ADXS-PSA, two immunotherapies with varying mechanisms, in advanced prostate cancer.”

KEYNOTE-046 is a multicenter, dose determining, open-label Phase 1/2 study designed to evaluate the safety and efficacy of ADXS-PSA as a monotherapy and in combination with KEYTRUDA in approximately 51 mCRPC patients. Part A of the study will be a dose escalating study designed to establish the maximum tolerated dose of ADXS-PSA as a monotherapy. Part B will consist of a dose escalating trial of ADXS-PSA in combination with KEYTRUDA, followed by an expansion cohort phase. The primary objective is to evaluate safety and tolerability of the two immunotherapies, with the secondary objective to evaluate anti-tumor activity and progression-free survival (PFS). Further information about KEYNOTE-046 can be found on ClinicalTrials.gov, using Identifier NCT02325557.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in six will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that approximately 233,000 new cases of prostate cancer will be diagnosed and about 30,000 men are expected to die of the disease this year.

About ADXS-PSA

ADXS-PSA is an Lm-LLO immunotherapy that is designed to target the prostate-specific antigen (PSA), a protein produced exclusively by prostate cells that is associated with prostate cancer. ADXS-PSA secretes the PSA antigen, fused to the powerful immunostimulant tLLO, directly inside the antigen presenting cells that are capable of driving a cellular immune response to PSA expressing cells. This approach is also designed to inhibit the Treg and myeloid-derived suppressor cells (MDSCs) that contribute to immunologic tolerance of prostate cancer. In preclinical analysis, ADXS-PSA inhibits the immunosuppression caused by Treg and MDSC cells localized inside tumors that may promote immunologic tolerance of prostate cancer.

About KEYTRUDA^® (pembrolizumab)

KEYTRUDA (pembrolizumab) is a humanized monoclonal antibody that blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, KEYTRUDA releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

KEYTRUDA is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merck is advancing a broad and fast-growing clinical development program for KEYTRUDA with more than 70 clinical trials – across more than 30 tumor types and over 8,000 patients – both as a monotherapy and in combination with other therapies.

Selected Important Safety Information for KEYTRUDA

Pneumonitis occurred in 12 (2.9%) of 411 patients with advanced melanoma receiving KEYTRUDA (the approved indication in the United States), including Grade 2 or 3 cases in 8 (1.9%) and 1 (0.2%) patients, respectively. Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 pneumonitis.

Colitis (including microscopic colitis) occurred in 4 (1%) of 411 patients, including Grade 2 or 3 cases in 1 (0.2%) and 2 (0.5%) patients respectively, receiving KEYTRUDA. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Hepatitis (including autoimmune hepatitis) occurred in 2 (0.5%) of 411 patients, including a Grade 4 case in 1 (0.2%) patient, receiving KEYTRUDA. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hypophysitis occurred in 2 (0.5%) of 411 patients, including a Grade 2 case in 1 and a Grade 4 case in 1 (0.2% each) patient, receiving KEYTRUDA. Monitor for signs and symptoms of hypophysitis. Administer corticosteroids for Grade 2 or greater hypophysitis. Withhold KEYTRUDA for Grade 2; withhold or discontinue for Grade 3; and permanently discontinue KEYTRUDA for Grade 4 hypophysitis.

Nephritis occurred in 3 (0.7%) patients receiving KEYTRUDA, consisting of one case of Grade 2 autoimmune nephritis (0.2%) and two cases of interstitial nephritis with renal failure (0.5%), one Grade 3 and one Grade 4. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.

Hyperthyroidism occurred in 5 (1.2%) of 411 patients, including Grade 2 or 3 cases in 2 (0.5%) and 1 (0.2%) patients respectively, receiving KEYTRUDA. Hypothyroidism occurred in 34 (8.3%) of 411 patients, including a Grade 3 case in 1 (0.2%) patient, receiving KEYTRUDA. Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer corticosteroids for Grade 3 or greater hyperthyroidism. Withhold KEYTRUDA for Grade 3; permanently discontinue KEYTRUDA for Grade 4 hyperthyroidism. Isolated hypothyroidism may be managed with replacement therapy without treatment interruption and without corticosteroids.

Other clinically important immune-mediated adverse reactions can occur. The following clinically significant, immune-mediated adverse reactions occurred in less than 1% of patients treated with KEYTRUDA: exfoliative dermatitis, uveitis, arthritis, myositis, pancreatitis, hemolytic anemia, partial seizures arising in a patient with inflammatory foci in brain parenchyma, adrenal insufficiency, myasthenic syndrome, optic neuritis, and rhabdomyolysis.

For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement of the adverse reaction to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Restart KEYTRUDA if the adverse reaction remains at Grade 1 or less. Permanently discontinue KEYTRUDA for any severe or Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

Based on its mechanism of action, KEYTRUDA may cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of KEYTRUDA.

For the treatment of advanced melanoma, KEYTRUDA was discontinued for adverse reactions in 6% of 89 patients who received the recommended dose of 2 mg/kg and 9% of 411 patients across all doses studied. Serious adverse reactions occurred in 36% of patients receiving KEYTRUDA. The most frequent serious adverse drug reactions reported in 2% or more of patients were renal failure, dyspnea, pneumonia, and cellulitis.

The most common adverse reactions (reported in ≥20% of patients) were fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash (29%), decreased appetite (26%), constipation (21%), arthralgia (20%), and diarrhea (20%).

The recommended dose of KEYTRUDA is 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks until disease progression or unacceptable toxicity. No formal pharmacokinetic drug interaction studies have been conducted with KEYTRUDA. It is not known whether KEYTRUDA is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with KEYTRUDA. Safety and effectiveness of KEYTRUDA have not been established in pediatric patients.

Please see Prescribing Information for KEYTRUDA (pembrolizumab) at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and the Medication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf

About Advaxis, Inc.

Advaxis is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm-LLO platform technology. The Lm-LLO technology, using bioengineered live attenuated Listeria monocytogenes bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs), that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis’s lead Lm-LLO immunotherapy, ADXS-HPV, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The FDA has granted Advaxis orphan drug designation for each of these three indications. The Company plans to initiate a registrational clinical program for cervical cancer in 2015 and has established licensing partners in India and Asia for commercialization in those regions. Advaxis entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca, for a Phase 1/2 immunotherapy study to evaluate the safety and efficacy of MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis’s ADXS-HPV as a treatment for patients with advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck cancer.

Advaxis’s second Lm-LLO immunotherapy candidate in clinical testing will be ADXS-PSA, which is being developed to address prostate cancer. Advaxis entered into a clinical trial collaboration agreement with Merck & Co., Inc. (“Merck”), known as MSD outside the United States and Canada, through its subsidiaries, to evaluate the combination of Advaxis’s Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck’s PD-1 checkpoint inhibitor KEYTRUDA^® (pembrolizumab). The planned clinical trial will evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab in a Phase 1/2 study of patients with previously treated metastatic, castration-resistant prostate cancer.

Advaxis is also developing Lm-LLO immunotherapy ADXS-cHER2, to target the Her2 receptor overexpressing cancers. Her2 is overexpressed in certain solid-tumor cancers, including pediatric bone cancer (or osteosarcoma), breast cancer, esophageal, and gastric cancer. ADXS-cHER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma.  Advaxis is developing ADXS-cHER2 for both human and animal-health, and has seen promising results in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis is planning to file an IND for ADXS-cHER2 in Her2 overexpressing cancers and to conduct a clinical program in pediatric osteosarcoma. Advaxis has licensed ADXS-cHER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for pet therapeutics.

For more information please visit www.advaxis.com.

Merck’s Focus on Cancer

Our goal is to translate breakthrough science into biomedical innovations to help people with cancer worldwide. For Merck Oncology, helping people fight cancer is our passion, supporting accessibility to our cancer medicines is our commitment, and pursuing research in immuno-oncology is our focus to potentially bring new hope to people with cancer. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

About Merck

Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Advaxis Forward-Looking Statement

This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis’s ability to develop the next generation of cancer immunotherapies; the safety and efficacy of Advaxis’s proprietary immunotherapy, ADXS HPV; whether Advaxis immunotherapies can redirect the powerful immune response all human beings have to the bacterium to cancers. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis’s SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

Merck Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation in the United States and internationally; global trends toward healthcare cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2014 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA

CONTACT: Company:
         Advaxis, Inc.
         Greg Mayes, Executive Vice President and COO
         mayes@advaxis.com
         609.452.9813 ext. 102

         Media Contact:
         Tiberend Strategic Advisors, Inc.
         Amy S. Wheeler
         awheeler@tiberend.com
         646.362.5750

         For Merck (Media):
         Pam Eisele
         267.305.3558

         Claire Mulhearn
         908.236.1118

         For Merck (Investors):
         Justin Holko
         908.740.1879

(DCTH) Adds New U.S. Center To Global Phase 2 Hepatocellular Carcinoma Program

Montefiore Medical Center in New York Opens for Enrollment

NEW YORK, April 7, 2015  — Delcath Systems, Inc. (NASDAQ: DCTH) announces the expansion of its global Phase 2 program for the treatment of patients with unresectable hepatocellular carcinoma (HCC) or primary liver cancer. Montefiore Medical Center in the Bronx, New York has joined the U.S. Phase 2 HCC study and is now open for patient enrollment. The Company now has two centers participating in the U.S. Phase 2 HCC study, with another three centers in Germany enrolling patients in the EU Phase 2 HCC study. The Company expects to include up to seven centers in Europe and the United States in its global Phase 2 HCC program, and will seek to enroll approximately 30 patients in total.

HCC is the most common primary cancer of the liver, with approximately 700,000 new cases diagnosed worldwide annually.  Surgical removal is not possible for an estimated 80-90 percent of primary liver cancer patients. In the U.S., the Phase 2 study will investigate the safety and efficacy of Melphalan/HDS treatment followed by sorafenib in patients with unresectable liver cancer confined to the liver, evaluate tumor response (objective response rate), as measured by modified Response Evaluation Criteria in Solid Tumor (mRECIST), assess progression-free survival, safety, and the safety of sorafenib following treatment with Melphalan/HDS. Additional analyses will be conducted to characterize the systemic exposure of melphalan administered by Melphalan/HDS, as well as an assessment of patient-reported clinical outcomes, or quality-of-life.

“We are pleased to have Montefiore Medical Center, a nationally recognized Center of Excellence for cancer care and clinical research, as a part of our global Phase 2 HCC program,” said Jennifer Simpson, Ph.D., Delcath’s Interim President and CEO. “We now have five centers open for patient enrollment in the program, and with our prospective commercial registry in Europe also now open for enrollment, we are continuing to execute on all elements of our Clinical Development Program.”

About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers. Our proprietary Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure. In April 2012 we obtained authorization to affix a CE Mark to our second-generation system, which is currently marketed in Europe as a device under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT). In the U.S. the Melphalan/HDS system is considered a combination drug and device product, and is regulated as a drug by the U.S. Food and Drug Administration (FDA). The Melphalan/HDS system has not been approved for sale in the U.S. We have commenced a global Phase 2 clinical trial in Europe and the U.S. to investigate the Melphalan/HDS system for the treatment of primary liver cancer (HCC), and expect to initiate a global Phase 3 trial in ocular melanoma (OM) that has metastasized to the liver and plan to evaluate intrahepatic cholangiocarcinoma (ICC) in a Phase 2 clinical study.

Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to: timely patient enrollment the ability to complete an interim evaluation of the Company’s Global Phase 2 HCC program, acceptance and publication of the Phase 3 trial manuscript and the impact of publication to support the Company’s efforts,  the timing and results of the Company’s  clinical trials including without limitation the HCC, ICC  and OM  clinical trial programs  timely enrollment and treatment of patients in the global Phase 2 HCC and ICC clinical trial, FDA approval of the global Phase 3 OM clinical trial protocol, IRB or ethics committee clearance of the Phase 2 HCC/ICC  and/or Phase 3 OM  protocols from  participating sites and the timing of site activation and subject enrollment in each trial, the impact of the presentations at ESSO and future clinical results consistent with the data presented, approval of Individual Funding Requests for reimbursement of the CHEMOSAT procedure, the impact, if any  of Value 4 status on potential CHEMOSAT product use and sales in Germany, clinical adoption, use and resulting sales, if any, for the CHEMOSAT system to deliver and filter melphalan in Europe including the key markets of Germany and the UK, the Company’s ability to successfully commercialize the Melphalan HDS/CHEMOSAT system and the potential of the Melphalan HDS/CHEMOSAT system as a treatment for patients with primary and metastatic disease in the liver, our ability to obtain reimbursement for the CHEMOSAT system in various markets, the Company’s ability to satisfy the requirements of the FDA’s Complete Response Letter and provide the same in a timely manner, approval of the current or future Melphalan HDS/CHEMOSAT system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in the U.S. and/or in foreign markets, actions by the FDA or other foreign regulatory agencies, the Company’s ability to successfully enter into strategic partnership and distribution arrangements in foreign markets and the timing and revenue, if any, of the same, uncertainties relating to the timing and results of research and development projects, our ability to maintain NASDAQ listing, and uncertainties regarding the Company’s ability to obtain financial and other resources for any research, development, clinical trials and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.

Contact Information:
Investor Contact:
LHA
Anne Marie Fields,
afields@lhai.com
212-838-3777

(LBIX) Three Significant Steps for Growth and Enhancing Shareholder Value

VANCOUVER, British Columbia, April 7, 2015  — Leading Brands, Inc. (Nasdaq:LBIX), North America’s only fully integrated healthy branded beverage company, announces that it is taking three significant steps to invest in the future of the Company and enhance shareholder value.

Leading Brands Chairman & CEO Ralph McRae said:

“We are intent upon increasing growth and enhancing shareholder value. To accomplish this, we are taking three significant steps to invest in our future that will place the Company in a strong position for long-term growth. They are:

• A new contract signed with our largest customer to ensure certainty of term;
• The Canada-wide roll-out of HappyWater® and new WaterBox™ packaging format; and
• An investment banker, Merriman & Co. of San Francisco, engaged to help us identify new strategic opportunities.

New Contract Provides Certainty

“Over the past few years, the lack of a formalized agreement with our largest bottling customer has inhibited us from investing in certain cost-saving measures to improve the combined efficiency of our main bottling and warehouse operations. With the new contract in place, we have initiated those cost reduction initiatives.

“While we expect long term benefits, we caution that in the short term the contract will likely impact our financial results. That’s because we had to provide our customer with certain financial incentives in order to achieve certainty of term – a trade off that will likely cause revenues to drop and will impact short-term profitability. We believe that the cost reductions we are now implementing will offset the vast majority of that impact. We expect to realize these benefits within a few months. On the whole, we will be a stronger organization, well positioned for growth and better able to capitalize on opportunities.

Realizing the Potential of HappyWater® and Implementing Innovative Packaging

“We will complete the roll-out of Happy Water® across major Canadian markets by mid-2015. This is just the beginning. If all goes well, we expect to launch into the US, likely in partnership with a select high-end retailer, at the end of this year.

“We are confident that consumers and retailers will be attracted to our blend of naturally alkaline spring and lithia water and that the product has the potential to return high margins and become self-sustaining. Our confidence is based on a three-year development program and test market in Vancouver, where we evolved and successfully implemented the brand message and marketing strategy.

“HappyWater® contains naturally occurring lithia at levels that have been clinically proven to provide improvements in mood and behaviour. If you have not seen last September’s New York Times article on the importance of lithia in your diet, I commend it to you: http://www.nytimes.com/2014/09/14/opinion/sunday/should-we-all-take-a-bit-of-lithium.html?_r=0. The timing of that recognition is uncanny.

“Moreover, our WaterBox™ format of packaging offers an attractive alternative to PET and BPA-laden water bottles for the fast-growing, health and environment-conscious consumer market. With 85% less plastic than conventional bottled water, the HappyWater® WaterBox™ not only dramatically reduces the environmental footprint of water packaging but also improves the way consumers integrate premium, naturally functional water into their everyday lives.

“We believe that the attributes of Happy Water® and WaterBox™ are sufficiently unique that they can be legally protected in addition to being difficult to replicate. Just as exciting, our box technology isn’t limited to water and we are exploring how our juice lines could benefit from this innovative packaging.

We Positioned the Company for this Success

“At the onset of the Great Recession in 2008, Leading Brands was significantly in debt and exposed to a contracting US market. We took action to protect the business and reposition the company for future growth.

“From March 1, 2009 through to the end of our last reported quarter we have (all amounts in Cdn$):

• Purchased almost $4,000,000 in new capital equipment, primarily to invest in our bottling plant and equipment to make us a more attractive partner to our customers, and new technology that facilitated the launch of the WaterBox™;
• Eliminated our long term debt of approximately $6,500,000;
• Repurchased almost 30% of Leading Brand’s issued and outstanding shares;
• Returned 85% of our net income to shareholders through the repurchase of shares;
• Increased the Company’s working capital by more than $2,000,000; and
• All while we developed an exciting new brand and packaging format for the Company, accomplished using existing cash flow.

“As a result, we are in a strong position to grow Leading Brands and create value for all shareholders. We are focused on realizing the benefits of our new contract with our largest customer, ensuring a successful North American-wide roll-out of HappyWater® and the careful consideration of potential new strategic initiatives utilizing the expertise of an experienced investment banker.

Considering New Initiatives

“With our business strengthened and positioned for growth, our investment banker’s broad mandate includes, as a top priority, finding us an acquisition target involving one or more healthy, fast-growing food or beverage brands that have a strong foothold in the US market and a proven ability to execute there.

“We have structured the contract with Merriman & Co. so that virtually all of their compensation is tied to results. While there is no certainty that a transaction will take place, we believe that we should be searching for good fits that will supplement our current business and accelerate our market penetration and development, particularly in the United States.

“We continue to be guided by a simple yet effective philosophy: improve our balance sheet, return profits to shareholders when appropriate and invest in our brands. This approach fueled our successful turnaround and we are confident it will continue to guide us as we now focus on growth and value creation for all shareholders.”

About Leading Brands, Inc.

Leading Brands, Inc. (Nasdaq:LBIX) is North America’s only fully integrated healthy beverage company. Leading Brands creates, designs, bottles, distributes and markets its own proprietary premium beverage brands via its unique Integrated Distribution System (IDS)™ which involves the Company finding the best and most cost-effective route to market. The Company strives to use the best natural ingredients hence its mantra: Better Ingredients – Better Brands.

Forward Looking Statements

Certain information contained in this document includes forward-looking statements, including statements regarding the Company’s plans and expectations, including regarding financial results, revenues and profitability, the benefits of cost saving measures, Happy Water® and WaterBox™, including the potential for those products to return high margins and become self-sustaining, and potential transactions.  Words such as “believe”, “expect,” “will,” or comparable terms, are intended to identify forward-looking statements concerning the Company’s expectations, beliefs, intentions, plans, objectives, future events or performance and other developments. Such forward-looking information is based on management’s expectations and assumptions, including that the new contract with the Company’s largest customer (the “Contract”) and the Company’s cost saving measures will have the effect on the Company’s financial results expected by management, that the cost saving measures will be implemented successfully, that the Company’s roll out of Happy Water® and the demand for and profitability of Happy Water® and WaterBox™ will be consistent with management’s expectations and that the Company’s efforts to identify and complete a suitable acquisition transaction will be successful.  Factors that could cause actual results to differ materially from those described herein include the Contract and cost saving measures having different effects on the Company’s financial results and operations than those expected by management, that the cost saving measures will not be implemented successfully, that the Company’s roll out of Happy Water® and the demand for and profitability of Happy Water® and WaterBox™ will not be consistent with management’s expectations, unanticipated competition with the Company’s products and that the Company’s efforts to identify and complete a suitable acquisition transaction will be unsuccessful, as well as the risks disclosed in the Company’s securities filings, which include the following: general economic conditions, weather conditions, changing beverage consumption trends, pricing, availability of raw materials, economic uncertainties (including currency exchange rates), government regulation, managing and maintaining growth, the effect of adverse publicity, litigation, competition and other risk factors described from time to time in securities reports filed by Leading Brands, Inc. There may be other factors that cause actual results not to be as anticipated, estimated or intended.  Readers should not place undue reliance on forward-looking information. For all such forward-looking statements, we claim the safe harbor for forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  All forward-looking statements included in this press release are based on information available to the Company on the date hereof and speak only as of the date hereof.  The Company undertakes no obligation to update these forward-looking statements, other than as required by applicable law.

Better Ingredients | Better Brands™

©2015 Leading Brands, Inc.

CONTACT: Leading Brands, Inc.
         Tel: (604) 685-5200
         Email: info@LBIX.com

(CTSO) Issues Responses to Frequently Asked Questions

MONMOUTH JUNCTION, N.J., April 7, 2015  — CytoSorbents Corporation (NASDAQ CM: CTSO), a critical care immunotherapy company using blood purification to treat critically-ill and cardiac surgery patients in multiple countries worldwide, has prepared a list of Frequently Asked Questions (“FAQs”) in response to shareholder inquiries following its 2014 Year End Earnings Call on March 31, 2015. A full transcript of the earnings call is available on the Company’s website, here.

Question: Can you provide some additional detail on your expectation that Q1 2015 product sales will be lower than Q4 2014?

Dr. Phillip Chan – CEO: First, let me reiterate that we firmly believe in the underlying fundamentals of our business and the value that CytoSorb® brings to the market.  Because of this, we expect 2015 sales of CytoSorb® to compare favorably to what we achieved in 2014.  Most important, we continue to receive positive feedback from physicians on how CytoSorb® has helped make a difference in outcomes of their critically-ill patients.

With that said, it is important to note that we are still in the very early stages of CytoSorb® commercialization, and that in this early stage of commercialization, we expect variability in our results due to the timing and size of specific orders, particularly those from distributors.  As a result, our focus is on the broader CytoSorb® sales trend rather than on quarter-to-quarter performance, as we believe this bigger picture perspective is a more accurate indicator of the traction that CytoSorb® is gaining in the market.  Q4 2014 and Q1 2015 are amongst the best quarterly results in the Company’s history, and continue to drive our trailing 12-month revenues higher.

It is also important to remember that this is a business that is directly targeting a massive $20 billion global opportunity of treating deadly inflammation in critically-ill and cardiac surgery patients, where CytoSorb® is uniquely positioned in a market with few to no other treatment options.  We are focused on maximizing the long-term opportunity for CytoSorb®, and the type of quarter-to-quarter variability we are seeing is expected and in no way diminishes the overall market potential for CytoSorb®.

To illustrate the magnitude of the medical problem, in Germany, there are 2,100 acute care hospitals, of which approximately 400 have more than 400 beds.  In these hospitals, approximately 10-20 percent of ICU admissions, or ~300-600 patients, will have severe sepsis or septic shock each year.  Based on usage patterns, a typical sepsis patient requires three-to-five treatments, or ~$3,000-$5,000 per patient in CytoSorb® revenue.  If CytoSorb® became standard-of-care for the treatment of sepsis, just one hospital would account for potentially $1 to $3 million in CytoSorb® revenue.  The revenue opportunity is even higher given the many other potential applications for CytoSorb® such as lung injury, trauma, burn injury, pancreatitis, liver failure, and cardiac surgery.  So although we are clearly not yet standard of care therapy, I point this out to demonstrate how large this opportunity could be, and how even modest success would completely dwarf our current performance.

Question: Can you share details of some recent case reports of CytoSorb® being used in the critical care setting?

            Within the past few weeks, we have received case reports that clearly demonstrate the value of CytoSorb® in the critical care setting. These examples demonstrate the ability of CytoSorb to not only improve patient outcomes, but save lives:

• A 13-year-old boy in septic shock and multiple organ failure in conjunction with an aggressively spreading drug-resistant-Staphylococcus aureus infection resulting from a major joint infection continued to rapidly deteriorate despite antibiotics and surgical debridement. Because of his dire situation, he was treated with CytoSorb® off-label for age, along with standard continuous renal replacement therapy. The patient’s condition rapidly stabilized, to the excitement of his treating physicians, marking his turning point towards a steady recovery. He was discharged home from the hospital several weeks later and, according to his family, is now playing soccer with friends
• A 72-year-old man suffering from septic shock and multiple organ failure after being admitted with a severe infection of unknown origin. CytoSorb® was used three times to help physicians stabilize his blood pressure and hemodynamics, ameliorating the situation and helping him recover.
• A 72-year-old woman who collapsed at home and couldn’t move. When found, she had developed kidney failure and a massive case of muscle injury and rhabdomyolysis with a myoglobin of 200,000 ng/mL from the fall and being immobilized. With no urine production and therefore no renal clearance of myoglobin, CytoSorb® treatment was felt to be a major contributor in rapidly reducing her myoglobin levels in the first 48 hours of therapy to less than 10,000 ng/mL, at which point her kidney function and urine output started to return and she began to recover

Question:  Can you offer more color on the need to restructure the sales force?

Dr. Chan [Comments modified from the conference call] – Growing a strong core sales team quickly is a challenging task.  First, we felt it necessary to support our dramatically expanding international distribution and partner network with someone who is experienced with selling CytoSorb® and can transmit this knowledge while helping to teach our distributors and their sales teams about the advances in CytoSorb® therapy that are happening elsewhere in the world.  At the beginning of Q4 2014, we promoted our Sales Director, who is one of our lead sales people in northern Germany, to become International Sales Director.  His replacement in northern Germany joined us in Q1 2015 and is excellent, but has not yet come fully up to speed, resulting in a temporary shortfall in sales in this important territory.

In addition, despite a tremendous amount of time and effort in selecting, hiring and training our new sales team, during Q1 we released four existing sales personnel to find stronger replacements who were better equipped to sell our therapy.  The remaining team, including recent additions to distributor support, product support and clinical support, is outstanding.  However, these changes to the sales team have created a significant gap in sales coverage in our direct sales territories (given that we divide Germany into multiple territories with one sales representative in each territory), which we believe has resulted in a temporary reduction in direct sales.  We continue to see strong interest throughout Germany, but we still need representatives on the ground with a strong physician network that can effectively detail the product and provide support and education at the reimbursement level, the hospital administration level, the physician level and the nursing level.  This is similar to every other medical device company and is not unique to our company or product.  However, unlike most companies that sell “me-too” products, CytoSorb® is a unique technology, treating complex, life-threatening conditions, requiring a sales team with specialized skills.  We have been actively recruiting additional sales people and have already identified two potential replacements with the skill set we are seeking.  This gives us confidence that the restructuring will be completed in the next several months.

We believe it is important to address potential issues proactively, and believe these changes are integral to maximizing the long-term opportunity for CytoSorb®.  More important, we believe they will have a significantly positive benefit beginning in the second half of 2015.  Meanwhile, we will continue to focus on the two other drivers of revenue growth: distributor and strategic partner sales where we see near term catalysts.

Question:  Why do you expect quarter-over-quarter growth to resume, and what steps are you taking to accelerate that sequential growth?

Dr. Chan:  Based upon our market intelligence, discussions with physicians from all over the world, and observations from numerous critical care and cardiac surgery conferences, we believe that the interest in CytoSorb® in the medical community has never been higher.  The physician interest and participation at our exhibit booth, User’s Meetings, and research symposia at major conferences such as DIVI 2014, the 44^th Annual Meeting of the German Society for Thoracic and Cardiovascular Surgery in February 2015, and the Symposium of Intensive Medicine and Intensive Care in Bremen, Germany in February 2015 underscores this belief in the growing interest in CytoSorb®. Most recently, we showcased CytoSorb® at ISICEM 2015 in Brussels, Belgium, and interest in the product there was the most robust that we have seen to date.  We believe that these indicators all point to healthy and growing awareness of, and interest in, our therapy.

In the meantime, we have been systematically establishing the foundation to make CytoSorb® a standard-of-care therapy for different applications and to drive significant future growth.  These initiatives are occurring in several major areas, including:

Sales and Marketing:

• Upgrading our direct sales force, distributor support infrastructure, and customer service in Germany to help convert the considerable, positive physician awareness that is growing around the world into new CytoSorb® usage and sales
• Working to expand awareness and usage of CytoSorb® amongst more physicians at our existing hospital customers.  Currently the vast majority of our sales are repeat orders from existing direct customers and distributors, a proxy for continued usage by treating physicians
• Expanding our geographic footprint of CytoSorb® sales through additional distributors and partners.  Key to this approach is facilitating the timely registration of CytoSorb® in strategic territories
• Expansion of marketing materials such as the recently launched CytoSorb® website to help centralize and disseminate information about CytoSorb® to a global audience, and teach how it is being used successfully today in case reports and clinical studies. We’ll continue to update the website throughout the year to make sure our customers have the most recent information about CytoSorb®
• Enhancing our professional education and distributor support capabilities to help better train our direct and distributors’ sales professionals, and provide the ongoing support necessary to position them for success in the field

Clinical Data:

• Building our clinical development capabilities, with expansion of our clinical trial team, to generate new evidence and a robust body of knowledge and help drive further adoption of CytoSorb®
• Funding a U.S. clinical development program in cardiac surgery that is designed to support U.S. FDA approval.  Cardiac surgery data generated from this program could be used to support cardiac surgery sales worldwide
• Overseeing more than 50 investigator initiated studies in a diverse set of therapeutic applications, where a number of the dozen studies currently enrolling patients will be completed this year, with data to be made available when possible
• Continued funding of new clinical trials specifically in sepsis, our largest target market, both in the U.S. and abroad
• Collection of global CytoSorb® treatment data under our International CytoSorb® Registry, that can used to evaluate safety, therapeutic indications, and answer questions such as “who, when and how to treat?”. This registry can also be data-mined for publications and to help answer critical treatment questions

Fostering Strategic Partnerships:

• Our multi-country strategic partnership with Fresenius Medical Care, the world’s largest dialysis company, to commercialize our CytoSorb® therapy for critical care applications in France, Poland, Sweden, Denmark, Norway, and Finland, is just getting off the ground. Both sides continue to invest significant resources toward a successful CytoSorb® launch, which is targeted to start this quarter
• Our strategic partnership with Biocon Ltd, Asia’s largest biotechnology company, continues to expand. They have become a trusted partner, and have done an excellent job in driving usage and awareness in India. We are now in the planning stages of developing clinical studies in India that Biocon will fund to help further build the clinical data that will drive future use and adoption
• We are now in the active market evaluation of CytoSorb® in our initial partnership with one of the top four global medical device companies in cardiac surgery. We expect this evaluation to be completed in the near future, and if successful, we plan to discuss next steps with them for a potentially broader partnership
• We will continue to support our existing partnerships while potentially seeking new ones for CytoSorb® and our advanced pipeline that includes HemoDefend™, ContrastSorb, DrugSorb and others. In doing so, we believe we can help unlock the significant value of our products

Thought Leadership

• We have established close relationships with key opinion leaders from all over the world. Most are intensive care physicians, cardiac surgeons, nephrologists, and perfusionists who have strong interest in new treatments to help solve major problems in their respective fields. Many are these key opinion leaders are highly-regarded because of the significant scientific or clinical contributions they have made during their careers. Many have seen first-hand how CytoSorb® can impact the outcomes of critically-ill or cardiac surgery patients. Their support of our CytoSorb® therapy is important. Also important is their willingness to help us and to discuss our technology both publicly and privately.

Balancing Supply and Demand

• In anticipation of future demand, we continue to push forward with our plans to expand our manufacturing of CytoSorb®. This should help achieve cost-efficiencies and economies of scale, helping to improve the profitability of the CytoSorb® device and our overall business. We see this as a key investment in our future growth.

As can be seen, the Company is executing across a broad range of initiatives, coming off the most successful year in our Company’s history where we achieved nearly all of the milestones that we discussed in early 2014.  While achieving quarter-to-quarter sales growth is important as we continue working to increase traction in the market, we view the near-term fluctuations as simple growing pains. We are taking what we view as the necessary steps to pro-actively manage this short-term volatility, but the Company is being managed for optimal, sustainable success.

Question: Where are we with registration in different countries?

International distribution and strategic partner sales are again a major part of our expansion strategy, and expected to be a major contributor to sales going forward.  We have established distribution in more than 29 countries, and with successful product registration, we expect them to add cumulatively to revenue growth.  We are:

• Actively selling product in the E.U. in Germany, Italy, the U.K., Austria, Switzerland, Romania, Moldovia and the Netherlands, as well as in Turkey and India
• Currently registered in Saudi Arabia, and have completed a feasibility study that was a pre-requisite for Saudi FDA approval. If we secure this approval, it can be leveraged rapidly across all seven countries of the Gulf Cooperation Council (GCC) including the United Arab Emirates, Kuwait, Qatar, and others
• Registered in Australia through the Therapeutic Goods Administration (TGA), enabling us to expand there as well
• Expecting to hear about registration of CytoSorb in France, the second largest medical device market in the E.U., and the other five countries that are part of the Fresenius partnership that we signed several months ago, very soon
• In the final stages of Russian registration, one of the larger countries we plan to add for 2015. Conservatively, we expect this will occur in late Q4 2015 or Q1 2016, if not sooner. The Russian registration process has been very detailed and time consuming, but we believe we have crossed a major hurdle and are in the home stretch to add this country to our growing portfolio
• Have met the requirements to add Canadian registration to our ISO 13485 certification. This will allow CytoSorb® to be registered in Canada once all Health Canada requirements have been met
• Withdrawing from the registration process in Taiwan due to the ongoing significant complexity of this process, as disclosed in our Form 10-K

We also are working on continued international expansion with multiple registrations in process in other countries.  We cannot speculate as to when, if ever, sales from distributor or strategic partners in these countries will become a meaningful contributor to our revenues.  But as can be seen, we have many distributors that could come on-line soon, representing significant potential catalysts for future revenue growth.

Question:  You referenced the fall in the Euro as contributing to the expected sequential decline in Q1 2015 sales.  Can you please explain further?

Dr. Chan:  Currency exchange fluctuations are a potential problem for all companies with international sales, and do not reflect the health of a company’s business or future prospects.  Without delving into foreign exchange derivatives, there is little that we can do as a small company to hedge against these changes.  Our approach to reduce currency risk has been to diversify our revenue base and have sales outside the European Union based in dollars, and our European sales predominantly in Euros.  For the most part, it is unusual to see dramatic changes in currency over the course of a few months.  However, this is exactly what we saw in Q1 2015 with the Euro falling precipitously against the dollar as Switzerland eliminated their currency cap to the Euro.  In Q1 2014, we received approximately $1.37 for every 1 Euro in sales.  In Q1 2015, we received only $1.05 for every 1 Euro in sales.  By itself, this currency exchange drop caused a 22% decrease in our expected revenues for Q1 2015, and again, has nothing to do with what we feel are the strong underlying fundamentals in our business.  On the positive side, what is not reflected in our revenue guidance for Q1 2015 is a reduction in expenses from our European operations and clinical studies, since we fund these activities with US dollars and benefit from a stronger dollar.

Question: What is the timing of the US REFRESH Trial?

Dr. Chan:  We have selected the site that will lead our REFRESH trial and have discussed and received verbal agreement from three major cardiac surgery centers to participate in the trial.  This meets the 3-center criterion of the feasibility study approved by the FDA in January.  The next steps are institutional IRB approvals of the study.  Once this is completed, we will execute clinical trial agreements and initiate the sites.  We expect to begin and complete the study this year, and be in a position to file our pivotal trial IDE after meeting with the FDA shortly thereafter.

Question: Will there be an Annual Meeting?

Yes, we plan to have an annual meeting and will notify shareholders when the details have been finalized.

About CytoSorbents Corporation

CytoSorbents Corporation is a critical care focused immunotherapy company using blood purification to control severe inflammation — with the goal of preventing or treating multiple organ failure in life-threatening illnesses. Organ failure is the cause of nearly half of all deaths in the intensive care unit, with little to improve clinical outcome. CytoSorb®, the Company’s flagship product, is approved in the European Union and marketed in 29 countries around the world, as a safe and effective extracorporeal cytokine adsorber, designed to reduce the “cytokine storm” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury, and pancreatitis. These are conditions where the risk of death is extremely high, yet no effective treatments exist.  CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure.

CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption.  CytoSorbents has numerous products under development based upon this unique blood purification technology, protected by 32 issued US patents and multiple applications pending, including HemoDefend™, ContrastSorb, DrugSorb, and others.  Additional information is available for download on the Company’s website: http://www.cytosorbents.com/.

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2015, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.

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CTSO 8.21  0.91 Today 5d 1m 3m 1y 5y 10y CytoSorbents Issues Responses to Frequently Asked Questions MONMOUTH JUNCTION, N.J., April 7, 2015 /PRNewswire/ — CytoSorbents Corporation (NASDAQ CM: CTSO), a critical care immunotherapy company using blood purification to treat critically-ill and cardiac surgery patients in multiple countries worldwide, has prepared a list of Frequently Asked Questions (“FAQs”) in response to shareholder inquiries following its 2014 Year End Earnings Call on March 31, 2015. A full transcript of the earnings call is available on the Company’s website, here. Question: Can you provide some additional detail on your expectation that Q1 2015 product sales will be lower than Q4 2014? Dr. Phillip Chan – CEO: First, let me reiterate that we firmly believe in the underlying fundamentals of our business and the value that CytoSorb® brings to the market.  Because of this, we expect 2015 sales of CytoSorb® to compare favorably to what we achieved in 2014.  Most important, we continue to receive positive feedback from physicians on how CytoSorb® has helped make a difference in outcomes of their critically-ill patients. With that said, it is important to note that we are still in the very early stages of CytoSorb® commercialization, and that in this early stage of commercialization, we expect variability in our results due to the timing and size of specific orders, particularly those from distributors.  As a result, our focus is on the broader CytoSorb® sales trend rather than on quarter-to-quarter performance, as we believe this bigger picture perspective is a more accurate indicator of the traction that CytoSorb® is gaining in the market.  Q4 2014 and Q1 2015 are amongst the best quarterly results in the Company’s history, and continue to drive our trailing 12-month revenues higher. It is also important to remember that this is a business that is directly targeting a massive $20 billion global opportunity of treating deadly inflammation in critically-ill and cardiac surgery patients, where CytoSorb® is uniquely positioned in a market with few to no other treatment options.  We are focused on maximizing the long-term opportunity for CytoSorb®, and the type of quarter-to-quarter variability we are seeing is expected and in no way diminishes the overall market potential for CytoSorb®. To illustrate the magnitude of the medical problem, in Germany, there are 2,100 acute care hospitals, of which approximately 400 have more than 400 beds.  In these hospitals, approximately 10-20 percent of ICU admissions, or ~300-600 patients, will have severe sepsis or septic shock each year.  Based on usage patterns, a typical sepsis patient requires three-to-five treatments, or ~$3,000-$5,000 per patient in CytoSorb® revenue.  If CytoSorb® became standard-of-care for the treatment of sepsis, just one hospital would account for potentially $1 to $3 million in CytoSorb® revenue.  The revenue opportunity is even higher given the many other potential applications for CytoSorb® such as lung injury, trauma, burn injury, pancreatitis, liver failure, and cardiac surgery.  So although we are clearly not yet standard of care therapy, I point this out to demonstrate how large this opportunity could be, and how even modest success would completely dwarf our current performance. Question: Can you share details of some recent case reports of CytoSorb® being used in the critical care setting?             Within the past few weeks, we have received case reports that clearly demonstrate the value of CytoSorb® in the critical care setting. These examples demonstrate the ability of CytoSorb to not only improve patient outcomes, but save lives: A 13-year-old boy in septic shock and multiple organ failure in conjunction with an aggressively spreading drug-resistant-Staphylococcus aureus infection resulting from a major joint infection continued to rapidly deteriorate despite antibiotics and surgical debridement. Because of his dire situation, he was treated with CytoSorb® off-label for age, along with standard continuous renal replacement therapy. The patient’s condition rapidly stabilized, to the excitement of his treating physicians, marking his turning point towards a steady recovery. He was discharged home from the hospital several weeks later and, according to his family, is now playing soccer with friends A 72-year-old man suffering from septic shock and multiple organ failure after being admitted with a severe infection of unknown origin. CytoSorb® was used three times to help physicians stabilize his blood pressure and hemodynamics, ameliorating the situation and helping him recover. A 72-year-old woman who collapsed at home and couldn’t move. When found, she had developed kidney failure and a massive case of muscle injury and rhabdomyolysis with a myoglobin of 200,000 ng/mL from the fall and being immobilized. With no urine production and therefore no renal clearance of myoglobin, CytoSorb® treatment was felt to be a major contributor in rapidly reducing her myoglobin levels in the first 48 hours of therapy to less than 10,000 ng/mL, at which point her kidney function and urine output started to return and she began to recover Question:  Can you offer more color on the need to restructure the sales force? Dr. Chan [Comments modified from the conference call] – Growing a strong core sales team quickly is a challenging task.  First, we felt it necessary to support our dramatically expanding international distribution and partner network with someone who is experienced with selling CytoSorb® and can transmit this knowledge while helping to teach our distributors and their sales teams about the advances in CytoSorb® therapy that are happening elsewhere in the world.  At the beginning of Q4 2014, we promoted our Sales Director, who is one of our lead sales people in northern Germany, to become International Sales Director.  His replacement in northern Germany joined us in Q1 2015 and is excellent, but has not yet come fully up to speed, resulting in a temporary shortfall in sales in this important territory. In addition, despite a tremendous amount of time and effort in selecting, hiring and training our new sales team, during Q1 we released four existing sales personnel to find stronger replacements who were better equipped to sell our therapy.  The remaining team, including recent additions to distributor support, product support and clinical support, is outstanding.  However, these changes to the sales team have created a significant gap in sales coverage in our direct sales territories (given that we divide Germany into multiple territories with one sales representative in each territory), which we believe has resulted in a temporary reduction in direct sales.  We continue to see strong interest throughout Germany, but we still need representatives on the ground with a strong physician network that can effectively detail the product and provide support and education at the reimbursement level, the hospital administration level, the physician level and the nursing level.  This is similar to every other medical device company and is not unique to our company or product.  However, unlike most companies that sell “me-too” products, CytoSorb® is a unique technology, treating complex, life-threatening conditions, requiring a sales team with specialized skills.  We have been actively recruiting additional sales people and have already identified two potential replacements with the skill set we are seeking.  This gives us confidence that the restructuring will be completed in the next several months. We believe it is important to address potential issues proactively, and believe these changes are integral to maximizing the long-term opportunity for CytoSorb®.  More important, we believe they will have a significantly positive benefit beginning in the second half of 2015.  Meanwhile, we will continue to focus on the two other drivers of revenue growth: distributor and strategic partner sales where we see near term catalysts. Question:  Why do you expect quarter-over-quarter growth to resume, and what steps are you taking to accelerate that sequential growth? Dr. Chan:  Based upon our market intelligence, discussions with physicians from all over the world, and observations from numerous critical care and cardiac surgery conferences, we believe that the interest in CytoSorb® in the medical community has never been higher.  The physician interest and participation at our exhibit booth, User’s Meetings, and research symposia at major conferences such as DIVI 2014, the 44th Annual Meeting of the German Society for Thoracic and Cardiovascular Surgery in February 2015, and the Symposium of Intensive Medicine and Intensive Care in Bremen, Germany in February 2015 underscores this belief in the growing interest in CytoSorb®. Most recently, we showcased CytoSorb® at ISICEM 2015 in Brussels, Belgium, and interest in the product there was the most robust that we have seen to date.  We believe that these indicators all point to healthy and growing awareness of, and interest in, our therapy. In the meantime, we have been systematically establishing the foundation to make CytoSorb® a standard-of-care therapy for different applications and to drive significant future growth.  These initiatives are occurring in several major areas, including: Sales and Marketing: Upgrading our direct sales force, distributor support infrastructure, and customer service in Germany to help convert the considerable, positive physician awareness that is growing around the world into new CytoSorb® usage and sales Working to expand awareness and usage of CytoSorb® amongst more physicians at our existing hospital customers.  Currently the vast majority of our sales are repeat orders from existing direct customers and distributors, a proxy for continued usage by treating physicians Expanding our geographic footprint of CytoSorb® sales through additional distributors and partners.  Key to this approach is facilitating the timely registration of CytoSorb® in strategic territories Expansion of marketing materials such as the recently launched CytoSorb® website to help centralize and disseminate information about CytoSorb® to a global audience, and teach how it is being used successfully today in case reports and clinical studies. We’ll continue to update the website throughout the year to make sure our customers have the most recent information about CytoSorb® Enhancing our professional education and distributor support capabilities to help better train our direct and distributors’ sales professionals, and provide the ongoing support necessary to position them for success in the field Clinical Data: Building our clinical development capabilities, with expansion of our clinical trial team, to generate new evidence and a robust body of knowledge and help drive further adoption of CytoSorb® Funding a U.S. clinical development program in cardiac surgery that is designed to support U.S. FDA approval.  Cardiac surgery data generated from this program could be used to support cardiac surgery sales worldwide Overseeing more than 50 investigator initiated studies in a diverse set of therapeutic applications, where a number of the dozen studies currently enrolling patients will be completed this year, with data to be made available when possible Continued funding of new clinical trials specifically in sepsis, our largest target market, both in the U.S. and abroad Collection of global CytoSorb® treatment data under our International CytoSorb® Registry, that can used to evaluate safety, therapeutic indications, and answer questions such as “who, when and how to treat?”. This registry can also be data-mined for publications and to help answer critical treatment questions Fostering Strategic Partnerships: Our multi-country strategic partnership with Fresenius Medical Care, the world’s largest dialysis company, to commercialize our CytoSorb® therapy for critical care applications in France, Poland, Sweden, Denmark, Norway, and Finland, is just getting off the ground. Both sides continue to invest significant resources toward a successful CytoSorb® launch, which is targeted to start this quarter Our strategic partnership with Biocon Ltd, Asia’s largest biotechnology company, continues to expand. They have become a trusted partner, and have done an excellent job in driving usage and awareness in India. We are now in the planning stages of developing clinical studies in India that Biocon will fund to help further build the clinical data that will drive future use and adoption We are now in the active market evaluation of CytoSorb® in our initial partnership with one of the top four global medical device companies in cardiac surgery. We expect this evaluation to be completed in the near future, and if successful, we plan to discuss next steps with them for a potentially broader partnership We will continue to support our existing partnerships while potentially seeking new ones for CytoSorb® and our advanced pipeline that includes HemoDefend™, ContrastSorb, DrugSorb and others. In doing so, we believe we can help unlock the significant value of our products Thought Leadership We have established close relationships with key opinion leaders from all over the world. Most are intensive care physicians, cardiac surgeons, nephrologists, and perfusionists who have strong interest in new treatments to help solve major problems in their respective fields. Many are these key opinion leaders are highly-regarded because of the significant scientific or clinical contributions they have made during their careers. Many have seen first-hand how CytoSorb® can impact the outcomes of critically-ill or cardiac surgery patients. Their support of our CytoSorb® therapy is important. Also important is their willingness to help us and to discuss our technology both publicly and privately. Balancing Supply and Demand In anticipation of future demand, we continue to push forward with our plans to expand our manufacturing of CytoSorb®. This should help achieve cost-efficiencies and economies of scale, helping to improve the profitability of the CytoSorb® device and our overall business. We see this as a key investment in our future growth. As can be seen, the Company is executing across a broad range of initiatives, coming off the most successful year in our Company’s history where we achieved nearly all of the milestones that we discussed in early 2014.  While achieving quarter-to-quarter sales growth is important as we continue working to increase traction in the market, we view the near-term fluctuations as simple growing pains. We are taking what we view as the necessary steps to pro-actively manage this short-term volatility, but the Company is being managed for optimal, sustainable success. Question: Where are we with registration in different countries? International distribution and strategic partner sales are again a major part of our expansion strategy, and expected to be a major contributor to sales going forward.  We have established distribution in more than 29 countries, and with successful product registration, we expect them to add cumulatively to revenue growth.  We are: Actively selling product in the E.U. in Germany, Italy, the U.K., Austria, Switzerland, Romania, Moldovia and the Netherlands, as well as in Turkey and India Currently registered in Saudi Arabia, and have completed a feasibility study that was a pre-requisite for Saudi FDA approval. If we secure this approval, it can be leveraged rapidly across all seven countries of the Gulf Cooperation Council (GCC) including the United Arab Emirates, Kuwait, Qatar, and others Registered in Australia through the Therapeutic Goods Administration (TGA), enabling us to expand there as well Expecting to hear about registration of CytoSorb in France, the second largest medical device market in the E.U., and the other five countries that are part of the Fresenius partnership that we signed several months ago, very soon In the final stages of Russian registration, one of the larger countries we plan to add for 2015. Conservatively, we expect this will occur in late Q4 2015 or Q1 2016, if not sooner. The Russian registration process has been very detailed and time consuming, but we believe we have crossed a major hurdle and are in the home stretch to add this country to our growing portfolio Have met the requirements to add Canadian registration to our ISO 13485 certification. This will allow CytoSorb® to be registered in Canada once all Health Canada requirements have been met Withdrawing from the registration process in Taiwan due to the ongoing significant complexity of this process, as disclosed in our Form 10-K We also are working on continued international expansion with multiple registrations in process in other countries.  We cannot speculate as to when, if ever, sales from distributor or strategic partners in these countries will become a meaningful contributor to our revenues.  But as can be seen, we have many distributors that could come on-line soon, representing significant potential catalysts for future revenue growth. Question:  You referenced the fall in the Euro as contributing to the expected sequential decline in Q1 2015 sales.  Can you please explain further? Dr. Chan:  Currency exchange fluctuations are a potential problem for all companies with international sales, and do not reflect the health of a company’s business or future prospects.  Without delving into foreign exchange derivatives, there is little that we can do as a small company to hedge against these changes.  Our approach to reduce currency risk has been to diversify our revenue base and have sales outside the European Union based in dollars, and our European sales predominantly in Euros.  For the most part, it is unusual to see dramatic changes in currency over the course of a few months.  However, this is exactly what we saw in Q1 2015 with the Euro falling precipitously against the dollar as Switzerland eliminated their currency cap to the Euro.  In Q1 2014, we received approximately $1.37 for every 1 Euro in sales.  In Q1 2015, we received only $1.05 for every 1 Euro in sales.  By itself, this currency exchange drop caused a 22% decrease in our expected revenues for Q1 2015, and again, has nothing to do with what we feel are the strong underlying fundamentals in our business.  On the positive side, what is not reflected in our revenue guidance for Q1 2015 is a reduction in expenses from our European operations and clinical studies, since we fund these activities with US dollars and benefit from a stronger dollar. Question: What is the timing of the US REFRESH Trial? Dr. Chan:  We have selected the site that will lead our REFRESH trial and have discussed and received verbal agreement from three major cardiac surgery centers to participate in the trial.  This meets the 3-center criterion of the feasibility study approved by the FDA in January.  The next steps are institutional IRB approvals of the study.  Once this is completed, we will execute clinical trial agreements and initiate the sites.  We expect to begin and complete the study this year, and be in a position to file our pivotal trial IDE after meeting with the FDA shortly thereafter. Question: Will there be an Annual Meeting? Yes, we plan to have an annual meeting and will notify shareholders when the details have been finalized. About CytoSorbents Corporation CytoSorbents Corporation is a critical care focused immunotherapy company using blood purification to control severe inflammation — with the goal of preventing or treating multiple organ failure in life-threatening illnesses. Organ failure is the cause of nearly half of all deaths in the intensive care unit, with little to improve clinical outcome. CytoSorb®, the Company’s flagship product, is approved in the European Union and marketed in 29 countries around the world, as a safe and effective extracorporeal cytokine adsorber, designed to reduce the “cytokine storm” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury, and pancreatitis. These are conditions where the risk of death is extremely high, yet no effective treatments exist.  CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure. CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption.  CytoSorbents has numerous products under development based upon this unique blood purification technology, protected by 32 issued US patents and multiple applications pending, including HemoDefend™, ContrastSorb, DrugSorb, and others.  Additional information is available for download on the Company’s website: http://www.cytosorbents.com/. Forward-Looking Statements This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2015, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws. Please Click to Follow Us on Facebook and Twitter Logo – http://photos.prnewswire.com/prnh/20140408/MM00899LOGO   To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/cytosorbents-issues-responses-to-frequently-asked-questions-300061922.html SOURCE CytoSorbents Corporation Source: PR Newswire (April 7, 2015 – 8:01 AM EDT)News by QuoteMedia

(ETRM) Announces Update on vBloc Therapy Trained Centers and Physicians

Fifteen Centers Certified and Nineteen Physicians Trained as of the end of the First Quarter of 2015

ST. PAUL, Minn., April 7, 2015  — EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that 15 centers have been certified and 19 physicians were trained in implanting and administering vBloc Therapy as of the end of the first quarter of 2015, supporting the company’s goal of training 20-25 vBloc Therapy centers and physicians by the end of 2015.

“Since receiving approval for vBloc Therapy in mid-January, we have been focused on identifying and training centers and physicians in key self-pay markets then working to integrate vBloc Therapy into their accounting and quality-assurance systems, a process  that can take 2-3 months per center,” said Brad Hancock, Chief Commercial Officer of EnteroMedics.  “In parallel, we have been developing materials and programs to support patient access to vBloc Therapy, including a partnership with a healthcare lending company, American HealthCare Lending, as well as hosting well-attended patient webinars to educate patients on vBloc Therapy and building resources to help patients navigate their insurance programs.  These efforts have put us on track to begin U.S. commercial implants this quarter.”

EnteroMedics’ bariatric center selection, training and certification process follows a defined protocol that includes rigorous center qualification criteria and didactic and surgical training. Once the center criteria are met, the Company’s field staff trains the surgeon and staff on vBloc Therapy, theory of operation, and program implementation.  This is followed by procedure and system operation training and one or two supervised surgeries, after which the surgeon is certified.

“The strong reception of vBloc Therapy by patients, centers and physicians has reinforced our belief that this first-of-its-kind treatment option fills the gap that exists between behavior modification or pharmaceutical options and anatomy altering and restricting surgery,” said Mark B. Knudson, PhD, President and CEO of EnteroMedics.  “We are pleased with the progress we have made with qualifying and training centers in the first quarter.  We believe we have a solid pipeline of patients, physicians and centers to support our goals during this initial, controlled phase of our commercialization rollout in 2015 and look forward to providing additional updates on our progress as the year unfolds.”

If you are interested in learning more about vBloc Therapy, please visit our physician locator at http://enteromedics.com/vbloc or call 1-800-MY-VBLOC.

About EnteroMedics Inc.

EnteroMedics is a medical device company focused on the development and commercialization of its neuroscience based technology to treat obesity and metabolic diseases. vBloc Therapy, delivered by a pacemaker-like device called the Maestro® Rechargeable System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. EnteroMedics’ Maestro Rechargeable System has received U.S. Food and Drug Administration approval, CE Mark and is listed on the Australian Register of Therapeutic Goods.

Information about the Maestro® Rechargeable System and vBloc® Therapy

You should not have an implanted Maestro Rechargeable System if you have cirrhosis of the liver, high blood pressure in the veins of the liver, enlarged veins in your esophagus or a significant hiatal hernia of the stomach; if you need magnetic resonance imaging (MRI); if you have a permanently implanted, electrical medical device; or if you need a diathermy procedure using heat.  The most common related adverse events that were experienced during clinical study of the Maestro System included pain, heartburn, nausea, difficulty swallowing, belching, wound redness or irritation, and constipation.

Talk with your doctor about the full risks and benefits of vBloc Therapy and the Maestro Rechargeable System. For additional prescribing information, please visit www.enteromedics.com/vbloc

Forward-Looking Safe Harbor Statement:

This press release contains forward-looking statements about EnteroMedics Inc. Our actual results could differ materially from those discussed due to known and unknown risks, uncertainties and other factors including our limited history of operations; our losses since inception and for the foreseeable future; our lack of commercial sales experience with our Maestro® Rechargeable System for the treatment of obesity in the United States or in any foreign market other than Australia and the European Community; our ability to comply with the Nasdaq continued listing requirements; our ability to commercialize our Maestro System; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for any modifications to our Maestro System; physician adoption of our Maestro System and vBloc® Therapy; our ability to obtain third party coding, coverage or payment levels; ongoing regulatory compliance; our dependence on third party manufacturers and suppliers; the successful development of our sales and marketing capabilities; our ability to raise additional capital when needed; international commercialization and operation; our ability to attract and retain management and other personnel and to manage our growth effectively; potential product liability claims; potential healthcare fraud and abuse claims; healthcare legislative reform; and our ability to obtain and maintain intellectual property protection for our technology and products. These and additional risks and uncertainties are described more fully in the Company’s filings with the Securities and Exchange Commission, particularly those factors identified as “risk factors” in the annual report on Form 10-K filed March 13, 2015. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

(SYRX) Awarded NASA SEWP V Contract

Big data software and infrastructure solutions provider Sysorex (NASDAQ: SYRX) today announced it been awarded a contract in the National Aeronautics and Space Administration’s (NASA) fifth Solutions for Enterprise-Wide Procurement (SEWP) contract vehicle. Sysorex received the contract award as part of the small business group otherwise known as “Group C”. The new vehicle has a maximum value of $20 billion with a base period of 5 years and one 5 year option period.

“We are very pleased to be a recipient of a NASA SEWP V award,” said Nadir Ali, CEO of Sysorex. “This is a prestigious contract that will allow Sysorex to offer a complement of systems and services to federal agencies worldwide, including our AirPatrol mobile device security and locationing systems and our advanced big data analytics platforms.”

Ali noted that Sysorex’s long-time partnerships and deep experience with leading technology vendors and OEMs allows it to offer a broad variety of state-of-the-art solutions as well as significant cost savings to customers across the federal spectrum.

The SEWP V contract is Sysorex’s second federal government win in the past month. In March the company was awarded a subcontract on the $249 million Enterprise Information Technology Services (EITS) Indefinite Delivery / Indefinite Quantity (ID/IQ) contract in support of the U.S. Army Program Executive Office for Enterprise Information Systems (PEO-EIS).

About SEWP V

The SEWP V procurement is for a Government-wide Agency Contract (GWAC) to provide Information Technology products, services, and solutions to the entire Federal sector. This procurement activity is the fifth iteration of SEWP, and is a follow-on to the SEWP IV contracts. The principal purpose of the SEWP V contracts is to provide state-of-the-art computer technologies, high-end scientific and engineering processing capabilities, peripherals, and network equipment. SEWP V will continue to provide a Government-wide capability to gain access to leading edge IT; provide direct access to IT products and services that are aligned with high-end technical requirements; optimize productivity through utilization of powerful computer systems, state of the art supporting peripherals and software on standardized but customizable systems; and ensure the availability of reliable and affordable IT to Federal agencies.

About Sysorex

Through focused, custom technology solutions, Sysorex (NASDAQ:SYRX) provides cyber security, data analytics, cloud solutions, Mobile/BYOD solutions and strategic outsourcing to government and commercial clients in major industries around the world. From identifying security risks to helping clients realize value from their big data strategies, Sysorex has the experience, technology, partners, and agility to be your trusted IT partner. Visit www.sysorex.com, follow @SysorexGlobal on Twitter and Like us on Facebook.

Safe Harbor Statement

All statements in this release that are not based on historical fact are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. While management has based any forward-looking statements included in this release on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties and other factors, many of which are outside of the control of the registrant and its subsidiaries, which could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not limited to, the fluctuation of global economic conditions, the performance of management and employees, our ability to obtain financing, competition, general economic conditions and other factors that are detailed in our periodic and current reports available for review at www.sec.gov. Furthermore, we operate in a highly competitive and rapidly changing environment where new and unanticipated risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise forward-looking statements.

(APDNW) Announces Record Date for Annual Stockholders’ Meeting

(BONE) Announces OsteoSponge(R) Patent

BELGRADE, Mont., April 6, 2015  — Bacterin International Holdings, Inc. (NYSE MKT:BONE), a leader in the development of revolutionary bone grafts, is pleased to announce that the United States Patent and Trademark Office has issued US Patent No. 8,992,964 entitled “Process for Demineralization of Bone Matrix with Preservation of Natural Growth Factors.” The issued claims in the patent cover certain demineralized bone matrixes containing minimum levels of bone morphogenetic protein-2 (BMP-2), which include products in Bacterin’s OsteoSponge^® product line. Bacterin has pending continuing applications in the United States to pursue protection on other aspects of its bone demineralization technology.

Bacterin’s Chief Scientific Officer, Gregory Juda, commented, “We are pleased to receive this patent that protects our proprietary demineralized bone products and recognizes the long term innovation of our company. This patent further substantiates our core competency in demineralized bone matrix technology and we are committed to maintaining our role as a leader in advancing orthobiologic technology.”

The OsteoSponge^® technology is two-fold; it allows for the allograft comprised of human bone to become compressible, while maintaining the spectrum of native growth factors inherent to bone. These growth factors are essential for the tissue regeneration process in the patient’s body. Because of this unique combination of properties, clinical investigators have been able to show fusion rates greater than 97 percent in peer-reviewed, published studies. Bacterin was the first company to commercialize a compressible DBM sponge marketed specifically for its handling characteristics, osteoconductive architecture, and osteoinductive properties for orthopedic bone grafting applications.

About Bacterin International Holdings

Bacterin International Holdings, Inc. (NYSE MKT:BONE) develops, manufactures and markets biologics products to domestic and international markets. These products are used in a variety of applications including enhancing fusion in spine surgery, relief of back pain, promotion of bone growth in foot and ankle surgery, promotion of cranial healing following neurosurgery and subchondral repair in knee and other joint surgeries.

For further information, please visit www.bacterin.com.

Important Cautions Regarding Forward-looking Statements

The presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward- looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the Company’s ability to meet its existing and anticipated contractual obligations, including financial covenant and other obligations contained in the Company’s secured lending facility; the Company’s ability to manage cash flow and achieve profitability; the Company’s ability to remain listed on the NYSE MKT; the Company’s ability to develop, market, sell and distribute desirable applications, products and services and to protect its intellectual property; the ability of the Company’s sales force to achieve expected results; the ability of the Company’s customers to pay and the timeliness of such payments; the Company’s ability to obtain financing as and when needed; changes in consumer demands and preferences; the Company’s ability to attract and retain management and employees with appropriate skills and expertise; the Company’s ability to successfully conclude government investigations; the impact of changes in market, legal and regulatory conditions and in the applicable business environment, including actions of competitors; and other factors. Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law.

CONTACT: COCKRELL GROUP
         877.889.1972
         investorrelations@thecockrellgroup.com
         cockrellgroup.com

(CYTX) and Lorem Vascular Receive Regulatory Clearance in China

Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today that its exclusive licensee, Lorem Vascular, has been granted regulatory clearance for the Cytori Celution® System by the State Food and Drug Administration of the People’s Republic of China (CFDA). This regulatory clearance officially makes Cytori’s Celution System available in the largest healthcare market in the world and triggers a substantial 2015 product purchase order for Cytori from Lorem Vascular.

Cytori’s exclusive licensee in the region, Lorem Vascular, has worked closely with Cytori during the last year preparing for CFDA clearance and planning for commercial introduction of the Celution family of products in China. Today’s news marks the first time that Cytori’s Celution System has gained any level of access to the mainland Chinese healthcare market. Lorem Vascular will begin product launch of Celution in key hospitals in China immediately.

“Our combined teams have spent the past year examining the delivery of healthcare in China and it is clear that diseases endemic is western countries are a rapidly growing burden on millions of citizens and already represent a heavy drain on resources of the healthcare system,” said David C. Oxley, Chief Executive Officer of Lorem Vascular. “With CFDA clearance, Lorem Vascular will now begin to consummate partnerships with key hospitals throughout China to address specific vascular and non-vascular applications using patients’ own adipose derived regenerative cells, which have demonstrated clinical promise in studies around the world.”

In November 2013, Cytori Therapeutics and Lorem Vascular entered into a 30-year exclusive licensing agreement to commercialize Cytori Celution System in China, Hong Kong, Malaysia, Singapore, and Australia. As part of that agreement, Lorem Vascular agreed to pay up to $500 million in fees to Cytori for a 30-year exclusive license for all indications, excluding alopecia, in the licensed territories following specific revenue milestones, as well as royalties of 30% on gross profits from Lorem’s operations in China, Malaysia and Hong Kong. Furthermore, following today’s news, Lorem Vascular placed an opening order of 23 Celution Devices and 1,100 Celution Consumable Sets, which is anticipated to be fulfilled throughout 2015. Following this opening order, Lorem Vascular has agreed to purchase annually a minimum of fifty (50) Celution Devices and fifty (50) Celution Consumable Sets for each of the Celution Devices for the next three years from CFDA clearance.

“Lorem Vascular’s commitment to the Chinese market, along with today’s CFDA clearance and receipt of the opening order from Lorem Vascular is an important part of our 2015 plan and a key milestone for the year,” said Tiago Girao, Vice President of Finance and CFO of Cytori Therapeutics. “We intend to continue our full support of Lorem Vascular as it expands its commercial efforts throughout its territories in the years ahead.”

About Cytori Therapeutics, Inc.

Cytori Therapeutics is a late stage cell therapy company developing laboratory equipment and autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information: visit www.cytori.com.

About Lorem Vascular

Lorem Vascular Pte. Ltd. is a leader in the new field of regenerative medicine. Headquartered in Singapore, with offices in Australia, China, Hong Kong, and Malaysia, Lorem Vascular is transforming the quality of patient care by enabling hospitals and doctors to address a variety of major vascular and non-vascular diseases using patients’ own cells.

(VBIV) Announces Research Collaboration With Sanofi Pasteur

• Sanofi Pasteur has chosen VBI’s LPV™ technology to develop a more stable formulation of a key Sanofi Pasteur vaccine candidate.
• The collaboration will leverage VBI’s LPV™ technology, which allows for the stabilization of vaccine antigens and biologics.

CAMBRIDGE, Mass., April 6, 2015  — VBI Vaccines Inc. (Nasdaq:VBIV) (“VBI”) announced today that it has entered into a research collaboration with Sanofi Pasteur to apply VBI’s LPV™ (Lipid Particle Vaccine) formulation technology to further the development of a key Sanofi Pasteur vaccine candidate.

Under the collaboration agreement, Sanofi Pasteur will leverage VBI’s LPV™ technology and expertise to reformulate a Sanofi Pasteur vaccine candidate to provide improved stability. The collaboration provides Sanofi Pasteur with the option to acquire certain worldwide rights to use VBI’s LPV™ technology in its vaccines. The vaccine candidate and the terms of the agreement were not disclosed.

“VBI is proud to be working with Sanofi Pasteur, a significant global vaccine manufacturer, to provide a more stable formulation of one of its key pipeline assets,” said Jeff Baxter, VBI’s President and CEO. “Our LPV™ technology has shown great promise in stabilizing vaccines and biologics of a variety of classes and targets. This collaboration reinforces the potential of our technology.”

Stability is a critical issue affecting vaccine potency, safety, and ultimately patient access. LPV™ technology has the potential to confer thermostability up to 40° C by using a proprietary process and lipids which surround and enclose the antigen (active component) of a vaccine or biologic. To learn more about VBI’s vaccine platforms, visit: http://www.vbivaccines.com/technology.

About VBI Vaccines Inc.

VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company developing novel technologies that seek to expand vaccine protection in large underserved markets. VBI’s eVLP vaccine platform allows for the design of enveloped (“e”) virus-like particle (“VLP”) vaccines that closely mimic the target virus. VBI’s lead eVLP asset is a prophylactic Cytomegalovirus (“CMV”) vaccine; VBI has initiated work for GMP manufacturing of its CMV candidate for use in formal preclinical and Phase I trials. VBI’s LPV platform is a thermostable technology that enables the development of vaccines and biologics that can withstand storage or shipment at constantly fluctuating temperatures. VBI has completed proof of concept thermostability studies on a number of vaccine and biologic targets. VBI is headquartered in Cambridge, MA with research facilities in Ottawa, Canada.

Website Home: http://www.vbivaccines.com/
News and Insights: http://www.vbivaccines.com/wire/
Investors: http://ir.vbivaccines.com/

Forward-Looking Statement Disclosure

This press release contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the efficacy of potential products, the timelines for bringing such products to market, and the availability of funding sources for continued development of such products. Forward-looking statements are based on management’s estimates, assumptions, and projections, and are subject to uncertainties, many of which are beyond the control of VBI. Actual results may differ materially from those anticipated in any forward-looking statement. Factors that may cause such differences include the risks that potential products that appear promising to VBI cannot be shown to be efficacious or safe in subsequent preclinical or clinical trials, VBI will not obtain appropriate or necessary governmental approvals to market these or other potential products, VBI may not be able to obtain anticipated funding for its development projects or other needed funding, and VBI may not be able to secure or enforce adequate legal protection, including patent protection, for its products. All forward-looking statements included in this press release are made only as of the date of this press release, and VBI does not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

More detailed information about VBI and risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this press release, is set forth in VBI’s filings with the Securities and Exchange Commission (the “Commission”). VBI urges investors and security holders to read those documents free of charge at the Commission’s Web site at http://www.sec.gov. Interested parties may also obtain those documents free of charge from VBI. Forward-looking statements speak only as to the date they are made, and except for any obligation under the U.S. federal securities laws, VBI undertakes no obligation to publicly update any forward-looking statement as a result of new information, future events or otherwise.

CONTACT: VBI Company Contact

         Jeff Baxter, President and CEO
         Phone: (617) 830-3031 x125
         Email: ir@vbivaccines.com

         VBI Investor Contacts

         Robert B. Prag, President
         The Del Mar Consulting Group, Inc.
         Phone: (858) 361-1786
         Email: bprag@delmarconsulting.com

         Scott Wilfong, President
         Alex Partners, LLC
         Phone: (425) 242-0891
         Email: scott@alexpartnersllc.com

(QURE) & (BMY) Enter into Exclusive Strategic Collaboration

Bristol-Myers Squibb Company (NYSE:BMY) and uniQure N.V. (NASDAQ:QURE) announced today an agreement that provides Bristol-Myers Squibb with exclusive access to uniQure’s gene therapy technology platform for multiple targets in cardiovascular diseases. The collaboration includes uniQure’s proprietary gene therapy program for congestive heart failure that is intended to restore the heart’s ability to synthesize S100A1, a calcium sensor and master regulator of heart function, and thereby improve clinical outcomes for patients with reduced ejection fraction. Beyond cardiovascular diseases, the agreement also includes the potential for target-exclusive collaboration in other disease areas. In total, the companies may collaborate on ten targets, including S100A1.

uniQure will lead discovery efforts and be responsible for manufacturing of clinical and commercial supplies using its vector technologies and its industrial, proprietary insect-cell based manufacturing platform. Bristol-Myers Squibb will lead development and regulatory activities across all programs and be responsible for all research and development costs. Bristol-Myers Squibb will be solely responsible for commercialization of all products from the collaboration.

“Bristol-Myers Squibb has an excellent and long-standing track record of success in discovering and developing treatments for cardiovascular diseases and in embracing advancing technologies for the treatment of human diseases,” said Carl Decicco, Ph.D., Head of Discovery, R&D, Bristol-Myers Squibb. “Collaborating with uniQure, a clear leader in the field with an innovative and validated gene therapy platform, further strengthens our capability to bring forward transformational new therapeutics for difficult-to-treat diseases, including cardiovascular diseases such as heart failure.”

“Bristol-Myers Squibb’s strength in the cardiovascular area and its commitment to gene therapy will allow them to leverage the full breadth and capacity of our platform for cardiovascular diseases,” said Joern Aldag, Chief Executive Officer of uniQure. “This collaboration will accelerate the application of gene therapy for large patient populations suffering from heart diseases and will complement the further development of uniQure’s internal pipeline in two focus areas: liver diseases, including hemophilia, and CNS, including lysosomal storage diseases.”

Under the terms of the agreement, Bristol-Myers Squibb will make near-term payments of approximately $100 million, including an upfront payment of $50 million to be made at the closing of the transaction, a $15 million payment for the selection of three collaboration targets, in addition to S100A1, to be made within three months of the closing and an initial equity investment in uniQure for a number of shares that will equal 4.9% of the total number of shares outstanding following such issuance, at a purchase price of $33.84 per share, or at least $32 million in total. Bristol-Myers-Squibb will acquire an additional 5.0% ownership before December 31, 2015, at a 10% premium, and will be granted two warrants to acquire up to an additional 10% equity interest, at a premium, based on additional targets being introduced into the collaboration. The parties have also agreed to enter into a supply contract, under which uniQure will undertake manufacturing of all gene therapy products under the collaboration.

uniQure will be eligible to receive research, development and regulatory milestone payments, including up to $254 million for the lead S100A1 therapeutic and up to $217 million for each other gene therapy product potentially developed under the collaboration. uniQure is also eligible to receive net sales based milestone payments and tiered single to double-digit royalties on product sales.

“It is immensely exciting to see the potential of our initial discoveries recognized first by uniQure and then advanced to a stage where we can build a portfolio of gene therapies to treat cardiovascular disease in partnership with Bristol-Myers Squibb,” added Prof. Dr. Patrick Most, Managing Director of uniQure Germany (formerly known as InoCard). “I would like to thank my colleagues in Heidelberg, Amsterdam and Lexington, Massachusetts for the teamwork that has contributed to bringing the lead S100A1 therapeutic closer to helping patients.”

uniQure and Bristol-Myers Squibb anticipate the collaboration to be effective during the second quarter of 2015. The effectiveness of the transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act. The initial issuance by uniQure of equity to Bristol-Myers Squibb also is anticipated to close in the second quarter of 2015 and is subject to the approval by the shareholders of uniQure.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

About uniQure

uniQure is delivering on the promise of gene therapy through single treatments with potentially curative results. We have developed a modular platform to rapidly bring new disease-modifying therapies to patients with severe disorders. We are engaged in multiple partnerships and have obtained regulatory approval of our lead product, Glybera, in the European Union for a subset of patients with LPLD. www.uniQure.com

Bristol-Myers Squibb Forward-Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that any of the investigational gene therapy programs described in this release will be successful. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2014 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

uniQure Forward-Looking Statement

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. These forward-looking statements include, but are not limited to, statements regarding the development of gene therapies for cardiovascular disease, the success of our collaboration with Bristol-Myers Squibb, the election by Bristol-Myers Squibb to extend the range of target indications covered by our collaboration, and the risk of cessation, delay or lack of success of any of our ongoing or planned clinical studies and/or development of our product candidates. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with collaboration arrangements, our and our collaborators’ clinical development activities, regulatory oversight, product commercialization and intellectual property claims, as well as the risks, uncertainties and other factors described under the heading “Risk Factors” in uniQure’s 2013 Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 25, 2014 and its 2014 Annual Report on Form 20-F to be filed with the Securities and Exchange Commission. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.

(BIND) Announces Extension of Global Collaboration with Pfizer

BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine platform company developing targeted and programmable therapeutics called Accurins™, today announced an extension of the terms of its global collaboration with Pfizer Inc. to create Accurins that optimize the therapeutic potential of two molecularly targeted oncology drugs in Pfizer’s pipeline. The collaboration was originally established in April 2013 and the timeline for Pfizer to exercise its option to acquire the exclusive license for the first program continues to be September 2015. Both companies agreed to an extension of the timeline for the second program through March 2016.

“We have made a great deal of progress in this collaboration and have shown promising preclinical results with Accurins containing each of the two compounds,” said Andrew Hirsch, president and chief executive officer, BIND Therapeutics. “Pfizer has been a terrific partner and the results to date have provided evidence that we are on track with the collaboration goals. We mutually agreed to extend the research terms for the second of the two selected compounds in order to ensure it is fully evaluated and well-positioned to enter IND-enabling studies.”

A development milestone was achieved for the first program in December 2014. The 2015 option target date on the first compound remains unchanged and this extension allows BIND and Pfizer an additional year to complete preclinical research evaluating the second program.

“Our Accurin development programs are active and of high interest to both companies,” said Robert Abraham, Ph.D., Senior Vice President and Chief Scientific Officer, Oncology Research Unit, Pfizer. “We are pleased to continue working with BIND under terms of the amended agreement.”

Under terms of the original agreement, Pfizer has the exclusive option to pursue development and commercialization of the Accurins selected. Both companies will work together on preclinical research, and if Pfizer exercises its option, Pfizer will have responsibility for development and commercialization of the selected Accurins.

BIND received an upfront payment of $4.0 million in 2013, a $1.0 million preclinical development milestone in December 2014, and has the potential to receive payments up to $88.5 million upon the achievement of additional specified development and regulatory events. BIND may also receive additional payments up to $110 million for specified commercial events as well as royalties in the low single to high single digit percentages on potential future sales of each Accurin commercialized, if any.

About BIND Therapeutics

BIND Therapeutics is a clinical-stage nanomedicine platform company developing a pipeline of Accurins, its novel targeted therapeutics designed to increase the concentration and duration of therapeutic payloads at disease sites while reducing exposure to healthy tissue. BIND is leveraging its Medicinal Nanoengineering platform to develop a pipeline of Accurins targeting hematological and solid tumors and has a number of strategic collaborations with biopharmaceutical companies to develop Accurins in areas of high unmet need. BIND’s lead drug candidate, BIND-014, is a prostate-specific membrane antigen (PSMA) -targeted Accurin that contains docetaxel, a clinically-validated and widely-used cancer chemotherapy drug. BIND-014 is currently in development for the treatment of non-small cell lung cancer, or NSCLC, in patients with KRAS mutations or squamous histology. In addition, BIND plans to initiate clinical trials with BIND-014 in cervical, bladder, head and neck and cholangio cancers in 2015. BIND is also advancing BIND-510, its second PSMA-targeted Accurin drug candidate containing vincristine, a potent microtubule inhibitor with dose limiting peripheral neuropathy in its conventional form, through important preclinical studies to position it for an Investigational New Drug (IND) application filing with the U.S. Food and Drug Administration (FDA) in 2016. Lastly, BIND is developing Accurins designed to inhibit PLK1 and KSP, both of which BIND believes are promising anti-mitotic targets that have been limited in the clinic due to myelotoxicity prior to reaching therapeutic doses.

BIND has announced ongoing collaborations with Pfizer Inc., AstraZeneca AB, F. Hoffmann-La Roche Ltd. and Merck & Co., or Merck (known as Merck Sharp & Dohme outside the United States and Canada), to develop Accurins based on their proprietary therapeutic payloads and targeting ligands.

Forward-Looking Statements Disclaimer

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the creation of Accurins based on drugs in Pfizer’s pipeline, including our expectations regarding IND-enabling studies, the achievement of potential milestones and potential receipt of additional payments and royalties; and expectations regarding BIND’s nanomedicine platform and pipeline.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the fact that the Company has incurred significant losses since its inception and expects to incur losses for the foreseeable future; the Company’s need for additional funding, which may not be available; raising additional capital may cause dilution to its stockholders or require it to relinquish rights to its technologies or drug candidates; the Company’s limited operating history; failure to use and expand its medicinal nanoengineering platform to build a pipeline of drug candidates and develop marketable drugs; the early stage of the Company’s development efforts with only one drug candidate in clinical development; failure of the Company or its collaborators to successfully develop and commercialize drug candidates; clinical drug development involves a lengthy and expensive process, with an uncertain outcome; delays or difficulties in the enrollment of patients in clinical trials; serious adverse or unacceptable side effects or limited efficacy observed during the development of the Company’s drug candidates; inability to maintain any of the Company’s collaborations, or the failure of these collaborations; the Company’s reliance on third parties to conduct its clinical trials and manufacture its drug candidates; the Company’s inability to obtain required regulatory approvals; any conclusion by the FDA that BIND-014 does not satisfy the requirements for approval under the Section 505(b)(2) regulatory approval pathway; the inability to obtain orphan drug exclusivity for drug candidates; failure to obtain marketing approval in international jurisdictions; any post-marketing restrictions or withdrawals from the market; effects of recently enacted and future legislation; failure to comply with environmental, health and safety laws and regulations; failure to achieve market acceptance by physicians, patients, or third-party payors; failure to establish effective sales, marketing and distribution capabilities or enter into agreements with third parties with such capabilities; effects of substantial competition; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; product liability lawsuits; failure to retain key executives and attract, retain and motivate qualified personnel; difficulties in managing our growth; risks associated with operating internationally, including the possibility of sanctions with respect to our operations in Russia; failure to obtain and maintain patent protection for or otherwise protect our technology and products; effects of patent or other intellectual property lawsuits; the eligibility of a significant portion of the Company’s total outstanding shares to be sold into the market, which could cause the market price of its common stock to drop significantly; increased costs as a result of operating as a public company; and any securities class action litigation. These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 11, 2015, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

(AKER) Signs Distribution Agreement With ADS for U.S. Govt.

THOROFARE, N.J., April 2, 2015  — Akers Biosciences, Inc. (Nasdaq:AKER) (AIM:AKR.L), (“Akers” or the “Company”), a medical device company focused on reducing the cost of healthcare through faster, easier diagnostics, has signed an exclusive Master Distributor Agreement with ADS Inc. (“ADS”) for the marketing and supply of Akers’ rapid diagnostic assays to U.S. Government agencies and departments (the “Agreement”).

ADS is the premier equipment procurement and support solutions specialist to the military, law enforcement, first responders and the defense industries in the United States.

The Agreement, which has an initial term of eighteen months, spans the entirety of Akers’ product catalog but will focus initially on marketing the Company’s rapid test for Heparin-Induced Thrombocytopenia (an allergic condition associated with the commonly used blood-thinner Heparin, generally used in various surgical procedures); the Company’s rapid, light-weight test for determining blood type compatibility in remote locations; and the Company’s range of rapid tests for infectious diseases including Malaria and Dengue Fever.

“Akers and ADS have identified a number of areas in which U.S. Government departments such as the Department of Defense could benefit significantly from the introduction of the Company’s rapid diagnostic assays,” said Raymond F. Akers, Jr. PhD, Co-founder and Executive Chairman of the Board.

“These include the introduction of the Company’s PIFA Heparin/PF4 rapid assays to military hospitals in order to reduce the costs and risks associated with the use of Heparin as a blood-thinning agent; our rapid blood-typing card for use in blood transfusions under battlefield conditions; and tests for infectious diseases such as Malaria and Dengue Fever out in the field or in remote locations where speed and ease of diagnosis are of paramount importance,” continued Dr. Akers.

“ADS is the preeminent distributor to this important target market so we are delighted to partner with them through this agreement to reach these large potential customers,” added Dr. Akers.

ABOUT AKERS BIOSCIENCES, INC.

Akers Biosciences develops, manufactures, and supplies rapid screening and testing products designed to deliver quicker and more cost-effective healthcare information to healthcare providers and consumers. The Company has advanced the science of diagnostics while responding to major shifts in healthcare through the development of several proprietary platform technologies. The Company’s state-of-the-art rapid diagnostic assays can be performed virtually anywhere in minutes when time is of the essence. The Company has aligned with major healthcare companies and high volume medical product distributors to maximize product offerings, and to be a major worldwide competitor in diagnostics.

Additional information on the Company and its products can be found at www.akersbiosciences.com. Follow us on Twitter @AkersBio.

ABOUT ADS INC.

ADS Inc. is a leading solutions provider that proudly serves all branches of the U.S. Military, federal, state and local government organization, law enforcement, first responders, foreign governments and the defense industry. The company is focused on solving customers’ challenges through the largest product and service selection, the broadest array of procurement and contract options, world-class support and logistics solutions and legendary customer service. ADS is a single source that actively seeks out customers’ equipment and logistics challenges to deliver innovative and cost-effective solutions that help them complete their mission and maintain readiness. ADS equipment and support solutions include C4ISR, Combat Support, Medical, Operational Clothing and Individual Equipment (OCIE), Weapons and Optics as well as Special Missions, including CWMD, CBRNe EOD, First Responders and Maritime Operations.

Additional information can be found at www.adsinc.com.

Cautionary Statement Regarding Forward Looking Statements

Statements contained herein that are not based upon current or historical fact are forward-looking in nature and constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements reflect the Company’s expectations about its future operating results, performance and opportunities that involve substantial risks and uncertainties. These statements include but are not limited to statements regarding the intended terms of the offering, closing of the offering and use of any proceeds from the offering. When used herein, the words “anticipate,” “believe,” “estimate,” “upcoming,” “plan,” “target”, “intend” and “expect” and similar expressions, as they relate to Akers Biosciences, Inc., its subsidiaries, or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to the Company and are subject to a number of risks, uncertainties, and other factors that could cause the Company’s actual results, performance, prospects, and opportunities to differ materially from those expressed in, or implied by, these forward-looking statements.

CONTACT: For more information:

         Akers Biosciences, Inc.
         Raymond F. Akers, Jr. PhD
         Executive Chairman of the Board
         Tel. +1 856 848 8698

         finnCap (UK Nominated Adviser and Broker)
         Geoff Nash / Scott Mathieson (Corporate Finance)
         Steve Norcross (Broking)
         Tel. +44 (0)20 7220 0500

         Taglich Brothers, Inc. (US Investor Relations)
         Chris Schreiber
         Tel. +1 917 445 6207

         Vigo Communications (UK Investor Relations)
         Ben Simons / Fiona Henson
         Tel. +44 (0)20 7016 9570
         akers@vigocomms.com

(FHCO) Reports Record Unit Sales for Second Quarter of FY2015

CHICAGO, April 2, 2015  — The Female Health Company (NASDAQ-CM: FHCO) today announced that it expects to report unit sales for the second quarter of FY2015 totaling approximately 20.8 million units.  This achievement represents an increase of approximately 184% relative to the corresponding period of the previous fiscal year and an increase of approximately 71% relative to the first quarter of FY2015.  It is also the largest quarterly unit sales in the Company’s history.

“This record volume of quarterly unit sales demonstrates that the Company is uniquely positioned to be able to deliver very large quantities of product in a very short time period,” stated Karen King, President and Chief Executive Officer of The Female Health Company.  “It also reinforces the continued importance of the FC2 Female Condom in protecting women against sexually transmitted diseases and in family planning programs around the World.”

In other news, the Company continues its work on the development of the US consumer market for female condoms.  “We are moving forward with a new brand and package design that is more complementary to the target user,” noted King.  “In the interim, we continue to work on establishing the infrastructure to support consumer product sales, which we intend to address primarily through social and digital marketing campaigns.  One of our most significant recent accomplishments involved the registration of the product with the relevant organizations to support reimbursement.”

“It is a little known fact that female condoms are reimbursable under the Affordable Care Act and most major health plans administered by United-Healthcare, Aetna, Humana, Kaiser, Cigna among many others,” continued King.  “For a large majority of the major health plans, the key requirement is a prescription from an in-network doctor to achieve full reimbursement.  We believe this provides further evidence of the value to the health care system of a female-controlled device that protects against unwanted pregnancy and sexually-transmitted diseases.  FC2 Female Condom offers women a non-hormonal birth control option under their control.  Many users report a high preference for female condoms over male condoms due to the less restrictive, more ‘natural’ experience provided by the unique design of the product.”

The Company will report its full financial results for the second quarter of FY2015 on April 30, 2015.  Management will host an investor conference call at 11:00 a.m. Eastern Time on April 30, 2015 to discuss year-to-date FY2015 financial results and other topics of interest.  Details for accessing the conference call will be forthcoming in a future press release.

About The Female Health Company

The Female Health Company, based in Chicago, Illinois, manufactures and markets the FC2 Female Condom® (FC2). Since the Company began distributing FC2 in 2007, the product has been shipped to 144 countries. The Company owns certain worldwide rights to the FC2 Female Condom®, including patents that have been issued in a number of countries around the world. The patents cover key aspects of FC2, including its overall design and manufacturing process.  The FC2 Female Condom® is the only currently available female-controlled product approved by FDA that offers dual protection against sexually transmitted infections, including HIV/AIDS, and unintended pregnancy. The World Health Organization (WHO) has cleared FC2 for purchase by U.N. agencies.

“Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995

The statements in this release which are not historical fact are “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995.  Forward-looking statements in this release include statements relating to expected unit sales in the second quarter of fiscal 2015 and the Company’s ability to successfully implement its growth strategy, and the effect of such strategy on the Company’s business and results of operations.  These statements are based upon the Company’s current plans and strategies, and reflect the Company’s current assessment of the risks and uncertainties related to its business, and are made as of the date of this release.  The Company assumes no obligation to update any forward-looking statements contained in this release as a result of new information or future events, developments or circumstances. Such forward-looking statements are inherently subject to known and unknown risks and uncertainties. The Company’s actual results and future developments could differ materially from the results or developments expressed in, or implied by, these forward-looking statements.  Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, the following:  product demand and market acceptance; competition in the Company’s markets and the risk of new competitors and new competitive product introductions; government contracting risks, including the appropriations process and funding priorities, potential bureaucratic delays in awarding contracts, process errors, politics or other pressures, and the risk that government tenders and contracts may be subject to cancellation, delay or restructuring; a governmental tender award indicates acceptance of the bidder’s price rather than an order or guarantee of the purchase of any minimum number of units, and as a result government ministries or other public sector customers may order and purchase fewer units than the full maximum tender amount; the Company’s reliance on its international partners in the consumer sector and on the level of spending on the female condom by country governments, global donors and other public health organizations in the global public sector; the economic and business environment and the impact of government pressures; risks involved in doing business on an international level, including currency risks, regulatory requirements, political risks, export restrictions and other trade barriers; the Company’s production capacity, efficiency and supply constraints; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company’s Form 10-K for the year ended September 30, 2014.  Actual events affecting the Company and the impact of such events on the Company’s operations may vary from those currently anticipated.

For more information about the Female Health Company visit the Company’s website at http://www.femalehealth.com and http://www.femalecondom.org. If you would like to be added to the Company’s e-mail alert list, please send an e-mail to FHCInvestor@femalehealthcompany.com.

(ARCW) Announces Pricing of Public Offering

DELAND, Fla., April 2, 2015  — ARC Group Worldwide, Inc. (“ARC”) (NASDAQ: ARCW) today announced the pricing of its public offering of 3,000,000 shares of common stock at a price to the public of $5.00 per share.  The gross proceeds to ARC from this offering are expected to be $15 million, before deducting the underwriting discount and other estimated offering expenses payable by ARC.  The offering is expected to close on or about April 8, 2015, subject to customary closing conditions.

Brean Capital, LLC and Imperial Capital, LLC are acting as joint book-running managers in the offering.

The underwriters have been granted a 30-day option to purchase up to an additional 450,000 shares of common stock from ARC to cover over-allotments, if any. The closing of the offering is expected to occur on April 8, 2015. The shares of ARC common stock issued pursuant to the offering will trade on NASDAQ under the symbol “ARCW” together with issued and trading shares of ARC common stock.

ARC plans to use all of the net proceeds from the offering to voluntarily prepay a portion of the outstanding indebtedness under ARC’s senior credit facility and subordinated credit facility loans which were used to finance the acquisitions of ATC, Thixoforming, Kecy, and Munson by ARC.

The securities described above are being offered by ARC pursuant to a registration statement previously filed with the Securities and Exchange Commission (the “SEC”), which became effective on April 1, 2015.  A final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov.  Copies of the final prospectus supplement and the accompanying prospectus relating to these securities may be obtained, when available, from Brean Capital, LLC, 1345 Avenue of the Americas, 29th Floor, New York, NY 10105, attention: Matt Picciano, phone: (212) 702-6536 / fax: (212) 702-6649, or by e-mail: Syndicate@breancapital.com; or Imperial Capital, LLC, 277 Park Avenue, 48th Floor, New York, NY 10172, attention: Steve Dearing phone: (212) 351-9433 / fax: (212) 351-9718.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About ARC Group Worldwide, Inc.

ARC Group Worldwide, Inc. is a leading global advanced manufacturing and 3D printing service provider. With its business founded in 1987, the Company offers its customers a compelling portfolio of advanced manufacturing technologies and cutting-edge capabilities to improve the efficiency of traditional manufacturing processes and accelerate their time to market. In addition to being a world leader in metal injection molding (“MIM”), ARC has significant expertise in 3D printing and imaging, materials science, advanced tooling, automation, machining, stamping, plastic injection molding, lean manufacturing, and robotics. For more information visit the website of ARC Group Worldwide, Inc.

Forward-Looking Statements

The forward-looking statements contained in this press release are based on ARC management’s current expectations, estimates and projections about future events. These include, but are not limited to, statements, if any, regarding business plans, pro-forma statements and financial projections, ARC’s ability to expand its services and realize growth.  All such “forward-looking statements” are made within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to risks and uncertainties.  These statements are not historical facts or guarantees of future performance, events or results. Such statements involve potential risks and uncertainties, and the general effects of financial, economic, and regulatory conditions affecting our industries. Accordingly, actual results may differ materially.  In particular, estimates regarding our anticipated quarterly performance are based upon currently available information; however, unpredictable events may arise before the closing of each quarterly financial period that could negatively affect actual quarterly performance outcomes.  These events may include orders that are withdrawn, delayed or returned, unexpected costs, change in currency exchange rates, and/or quality, workforce, and inventory issues.  ARC does not have any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For additional factors that may affect future results, please see filings made by ARC with the Securities and Exchange Commission (“SEC”), including its Form 10-K for the fiscal year ended June 30, 2014, Form 10-Q for the period ended September 28, 2014, and Form 10-Q for the period ended December 28, 2014 as well as our current reports on Form 8-K filed from time-to-time with the SEC.

CONTACT: Drew M. Kelley
PHONE: (303) 467-5236

Email: InvestorRelations@ArcGroupWorldwide.com

(NETE) & TAS Group Enter Strategic Partnership

TAS Group Will License Proprietary EMV Technology to Net Element and Resell Net Element Payment and Mobile Services

(BBLU) Announces Sumter CHP Plant Energized on March 30, 2015

(RPRX) Announces Acceptance for Filing of NDA

THE WOODLANDS, Texas, April 1, 2015  — Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that the New Drug Application (NDA) for its enclomiphene citrate product candidate, formerly known as Androxal®, has been accepted by the U.S. Food and Drug Administration (FDA), indicating that the application is sufficiently complete to permit a substantive review. This investigational product, which is the Company’s lead product candidate, is a single isomer of clomiphene citrate and an orally active proprietary small molecule compound. The Company is developing this product candidate for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. Men with secondary hypogonadism exhibit low testosterone levels due to under stimulated testes but they are generally fertile. The Company’s product candidate is designed to treat the underlying mechanism, insufficient stimulation of the testes by the pituitary, which causes secondary hypogonadism.

About Repros Therapeutics Inc.®

Repros Therapeutics focuses on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders

Forward-Looking Statements

Any statements made by the Company that are not historical facts contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to various risks, uncertainties and other factors that could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements. These statements often include words such as “may,” “will,” “expect,” “anticipate,” “continue,” “estimate,” “project,” “intend,” “believe,” “plan,” “seek,” “could,” “can,” “should” or similar expressions. These statements are based on assumptions that the Company has made in light of the Company’s experience in the industry, as well as the Company’s perceptions of historical trends, current conditions, expected future developments and other factors the Company believes are appropriate in these circumstances. Forward-looking statements include, but are not limited to, those relating to possible approval of the NDA by the FDA and the timeline for such approval and potential benefits and uses of the label for the product candidate and its commercial potential. Such statements are based on current expectations that involve a number of known and unknown risks, uncertainties and other factors that may cause actual events to be materially different from those expressed or implied by such forward-looking statements, including risks that the FDA will not complete review of the NDA by the PDUFA date, that the FDA may not ultimately approve the product candidate, the risk that the that any marketing approvals, if granted, may have significant limitations on use, that even if the NDA is approved, the Company may not be able to successfully commercialize the product candidate, risks relating to the Company’s ability to protect its intellectual property rights and such other risks as are identified in the Company’s most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

For more information, please visit the Company’s website at http://www.reprosrx.com.

CONTACT: Investor Relations:
         Thomas Hoffmann
         The Trout Group
         (646) 378-2931
         thoffmann@troutgroup.com

(TRIL) Announces Pricing of Public Offering of Securities

TORONTO, April 1, 2015  — Trillium Therapeutics Inc. (Nasdaq:TRIL) (TSX:TR) an immuno-oncology company developing innovative therapies for the treatment of cancer, today announced that it has priced an underwritten public offering of 1,522,395 common shares and 1,077,605 non-voting convertible preferred shares at a price of US$19.50 per share for aggregate gross proceeds of US$50.7 million before deducting underwriting discounts and commissions and other offering expenses.

Trillium has also granted the underwriters a 30-day option to purchase up to an additional 228,359 common shares, which, if exercised, would result in additional gross proceeds of approximately US$4.45 million. The offering is expected to close on or about April 7, 2015, subject to the satisfaction of customary closing conditions.

All of the shares in the offering are to be sold by Trillium, with net proceeds to be used to develop product candidates as well as for working capital and general corporate purposes.

Leerink Partners LLC and Cowen and Company, LLC are acting as joint book-runners for the offering. Oppenheimer & Co. Inc. is acting as co-manager in the offering.

The offering is being made pursuant to a registration statement on Form F-1 that has been filed with the U.S. Securities and Exchange Commission and has become effective. The offering is being made only by means of a prospectus. When available, copies of the prospectus relating to these securities may be obtained from: Leerink Partners LLC; Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or via telephone at (800) 808-7525 ext. 6142, or by email at syndicate@leerink.com; or from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, or by phone 631- 274-2806 / fax 631-254-7140.

This offering is restricted to persons who are not residents of Canada. Investors in the offered securities may not resell the purchased securities, directly or indirectly, to any resident of Canada or (in the case of the common shares) over the Toronto Stock Exchange or ‎otherwise in Canada for a period of 90 days following the completion of this offering.  Each investor will be deemed to agree to the above and to represent that it is not a resident of Canada upon acceptance of delivery of the purchased securities by the investor or its dealer or other representative.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

Forward-Looking Statements and Information

This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws in United States and Canada, respectively, which reflect Trillium’s current expectation regarding future events (collectively, “forward-looking statement”). Forward-looking statements in this press release include statements about the conduct and completion of the offering, the offering size and the use of proceeds therefrom. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such risks and uncertainties are described in Trillium’s ongoing quarterly and annual reporting. With respect to the forward-looking statements contained in this press release, Trillium has made numerous assumptions regarding, among other things: regulatory approval of the financing; stability of economic and market conditions; and the level of demand for Trilliums’ securities. While Trillium considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies. Except as required by applicable securities laws, Trillium undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Neither TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accepts responsibility for the adequacy or accuracy of this release.

CONTACT: Trillium Therapeutics Inc.
         James Parsons
         Chief Financial Officer
         +1 416 595 0627 x232
         james@trilliumtherapeutics.com
         www.trilliumtherapeutics.com

(NYMX) Announces Phase 3 BPH Studies

HASBROUCK HEIGHTS, N.J., April 1, 2015  — Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today that the Company is undertaking further analyses of its pivotal U.S. Phase 3 studies of NX-1207 for prostate enlargement (BPH). This will include new long-term data from Studies NX02-0017 and NX02-0018. The Company expects to provide these new pivotal Phase 3 study results in Q2 or early Q3 this year.

The pivotal U.S. studies NX02-0017 and NX02-0018 were initiated in 2009. Enrollment of NX02-0017 (499 patients randomized) was completed in 2012; enrollment of NX02-0018 (498 patients randomized) was completed in 2013. 973 patients were injected with either NX-1207 2.5 mg (n=582) or saline vehicle alone as control (n=391). At 12 months post-treatment there was no overall top-line statistical significance for the efficacy of treatment in terms of BPH Symptom Score improvement vs controls. The safety profile of NX-1207 was excellent.

Dr. Paul Averback, CEO of Nymox said, “Despite the setback of top-line results not initially beating controls statistically at 12 months post-treatment in these large studies, we continue to believe that NX-1207 has enormous potential for long-term management of BPH. Additional new blinded protocol data from the same pivotal studies is being prospectively captured in order to assess long-term results in patients up to 5 years after a single injection of NX-1207 2.5 mg vs placebo.”

NX-1207 is also in late-stage development for low grade localized prostate cancer. In 2014 the Company reported 8 month efficacy results showing statistically significant reduced cancer progression in patients who received NX-1207 compared to standard of care.

For more information please contact info@nymox.com or 800-936-9669.

This press release contains certain “forward-looking statements” as defined in the United States Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. There can be no assurance that such statements will prove to be accurate and the actual results and future events could differ materially from management’s current expectations. Development of drug products involves substantial risks and actual results may differ materially from expectations. Factors that could cause actual results or events to differ materially from those projected in forward-looking statements are detailed from time to time in Nymox’s filings with the United States Securities and Exchange Commission and other regulatory authorities.

CONTACT: For Further Information Contact:
         Paul Averback
         Nymox Pharmaceutical Corporation
         1-800-93NYMOX
         www.nymox.com

(INVT) $2.15 Million Common Stock Financing to Accelerate Licensing Operations