(SYRX) LG Electronics MobileCom, Sprint, Sysorex to Sponsor Go Mobile 2015 Conference

LG’s Leading Role in Go Mobile 2015 Signifies Its Commitment to Enterprise IT and Mobile Decision-Makers

(FNJN) USPTO Grants 23rd US Patent to Finjan for Malicious Mobile Code Protection

Bolstering Patent Coverage for Technologies Used in Cloud Enabled Cybersecurity Platforms

(PULM) to Report Clinical Data on PUR0200 in Patients with COPD

– Results to be Presented September 29th at 2015 European Respiratory Society Congress –

LEXINGTON, Mass., Sept. 23, 2015  — Pulmatrix, Inc. (NASDAQ: PULM) will report data from a Phase 1B study evaluating PUR0200, an iSPERSE formulation of a long acting muscarinic antagonist (LAMA) bronchodilator, on September 29^th at the 2015 European Respiratory Society Congress. PUR0200 is being developed under the PK bio-equivalence pathway in Europe.

The two-part, single dose, placebo controlled dose-ranging clinical study in 38 patients was designed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and safety and tolerability of PUR0200 compared to the reference product, a once daily LAMA bronchodilator. The main phase of the study was a 5-period crossover design with each patient receiving 3, 6, and 9 micrograms of PUR0200, 18 micrograms of the reference product, and an inhalation of placebo. PK results demonstrated that administration of PUR0200 resulted in dose proportional increases in plasma drug levels and all doses of PUR0200 improved pulmonary function compared to the placebo.  Further, inhalation of PUR0200 3 micrograms resulted in similar PK and PD as the reference at a nominal dose that is 80% less than the reference product, demonstrating the delivery advantages of the iSPERSE™ technology.  All doses of PUR0200 were safe and well tolerated.

Additional data from the study will be presented by David Hava, Ph.D., Chief Scientific Officer of Pulmatrix in a poster presentation. Details of the presentation are as follows:

About Pulmatrix

Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE™ technology. The Company’s proprietary product pipeline is focused on advancing treatments for rare diseases, including PUR1900, an inhaled anti-fungal for patients with cystic fibrosis (CF), as well as PUR1500, an inhaled product for the treatment of idiopathic pulmonary fibrosis. In addition, Pulmatrix is pursuing opportunities in major pulmonary diseases through collaborations, including PUR0200, a branded generic in clinical development for chronic obstructive pulmonary disease (COPD).  Pulmatrix’s product candidates are based on iSPERSE™, its proprietary dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.

(CTIC) To Submit NDA For Pacritinib In Q4

– Decision Follows Pre-NDA Meeting with the FDA to Request Accelerated Approval for Patients with Myelofibrosis and Low Platelet Counts – – Accelerated Approval to Be Requested Based on Single Trial, Potentially Reducing Time to Market –

SEATTLE, Sept. 23, 2015  — CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) today announced its plan to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) following a productive pre-NDA meeting for pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. The company expects to submit the NDA in the fourth quarter of 2015 and to request accelerated approval for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter (<50,000/uL). The NDA will be based primarily on data from the PERSIST-1 Phase 3 trial – as well as data from Phase 1 and 2 studies of pacritinib – and additional information requested by the FDA, including a separate study report and datasets for the specific patient population with low platelet counts of less than 50,000 per microliter (<50,000/uL) for whom there are no approved drugs. Submission of an NDA after a single Phase 3 trial under accelerated approval, instead of waiting to complete two Phase 3 trials, could potentially reduce time to market by up to 14 months.

Myelofibrosis is a rare and serious chronic blood cancer that can affect patients of all ages with a median age of 65 years, with an estimated prevalence in the United States of approximately 18,000 patients.

“This improved timing on the plan to submit an NDA – which is supported by data after completion of the PERSIST-1 trial – will allow us the potential for making pacritinib available to patients with low platelet counts earlier than expected,” said James A. Bianco, M.D., President and CEO of CTI BioPharma. “We look forward to working with the FDA on the submission and review of this application.”

PERSIST Update
Pacritinib is currently being evaluated in two Phase 3 clinical trials, known as the PERSIST program, for patients with myelofibrosis. PERSIST-1 is a randomized, open-label, multicenter Phase 3 trial comparing the efficacy and safety of pacritinib with that of best available therapy (exclusive of a JAK inhibitor) in 327 enrolled patients with myelofibrosis (primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis), regardless of the patients’ platelet counts. PERSIST-2 is a randomized, open-label, multicenter Phase 3 clinical trial evaluating pacritinib compared to best available therapy (BAT), including the approved JAK1/JAK2 inhibitor dosed according to product label for patients with myelofibrosis whose platelet counts are less than or equal to 100,000 per microliter. In October 2013, CTI BioPharma reached agreement with the FDA on a Special Protocol Assessment (SPA) for the PERSIST-2 trial. The SPA is a written agreement between CTI BioPharma and the FDA regarding the design, endpoints and planned statistical analysis approach of the trial to be used in support of a potential NDA submission. The design of PERSIST-1 and PERSIST-2 allows for patients on the BAT arm to crossover and receive treatment with pacritinib if their disease progresses or after they achieve the 24-week measurement endpoint. Although crossover design of clinical trials may confound evaluation of survival, such designs are frequently used in cancer studies, and the FDA has approved multiple oncology drugs that utilized crossover design in Phase 3 trials. The Independent Data Monitoring Committee (IDMC) for the PERSIST program recommended patients on the best available therapy arm should not crossover to receive pacritinib due to non-statistically significant safety concerns in patients who crossover after 24 weeks, which crossover confounds evaluation of survival. After receiving input from external independent experts and providing the FDA the PERSIST-1 data, IDMC’s recommendation and correspondence, CTI BioPharma and Baxalta notified the FDA of the decision to proceed per protocol. Following a written response in lieu of a Type C meeting with the FDA, CTI BioPharma and Baxalta determined that no modifications to the ongoing trials were required. Enrollment in PERSIST-2, which is designed to enroll up to 300 patients in North America, Europe, Australia, New Zealand and Russia is continuing. Based on current timelines, PERSIST-2 enrollment is expected to be completed in the first quarter of 2016. Additional details on PERSIST-2 are available at www.clinicaltrials.gov or www.PERSISTprogram.com.

About Pacritinib
Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. In August 2014, pacritinib was granted Fast Track designation by the FDA for the treatment of intermediate and high risk myelofibrosis, including but not limited to patients with disease-related thrombocytopenia, patients experiencing treatment-emergent thrombocytopenia on other JAK2 inhibitor therapy, or patients who are intolerant of, or whose symptoms are sub-optimally managed on other JAK2 inhibitor therapy. The FDA’s Fast Track process is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Pacritinib does not have regulatory approval and is not commercially available.

CTI BioPharma and Baxalta (NYSE:BXLT) are parties to a worldwide license agreement to develop and commercialize pacritinib. CTI BioPharma and Baxalta will jointly commercialize pacritinib in the U.S. while Baxalta has exclusive commercialization rights for all indications outside the U.S.

About CTI BioPharma
CTI BioPharma Corp. (NASDAQ and MTA: CTIC) is a biopharmaceutical company focused on the acquisition, development, and commercialization of novel targeted therapies covering a spectrum of blood-related cancers that offer a unique benefit to patients and healthcare providers. CTI BioPharma has a commercial presence in Europe and a late-stage development pipeline, including pacritinib, CTI BioPharma’s lead product candidate, which is currently being studied in a Phase 3 program for the treatment of patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington, with offices in London and Milan under the name CTI Life Sciences Limited. For additional information and to sign up for email alerts and get RSS feeds, please visit www.ctibiopharma.com.

Forward Looking Statements
This press release includes forward-looking statements related to pacritinib and related clinical trials conducted pursuant to a collaboration between CTI BioPharma Corp. and Baxalta Inc., which are within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are subject to a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of the issuers’ securities. Such statements include, but are not limited to, statements regarding expectations with respect to the potential therapeutic utility of pacritinib and the prevalence of myelofibrosis in the United States, plans and intentions with respect to the submission of an NDA requesting accelerated approval in the fourth quarter of 2015 or any other regulatory filings in Europe and other locations outside the US, the ability of the PERSIST-1 and Phase 1 and Phase 2 trials and additional information about pacritinib requested by the FDA to support a potential regulatory submission on an accelerated basis or otherwise, CTI BioPharma’s ability to provide the FDA with the additional data and information requested, potential for making pacritinib available to patients with significant thrombocytopenia earlier than expected and to shorten the time to market for pacritinib by 14 months, the ability to complete enrollment for PERSIST-2 by in the first quarter 2016 and the ability of pacritinib to meet unmet medical needs and future regulatory, development and commercialization plans. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and are based on assumptions about many important factors and information currently available to us to the extent we have thus far had an opportunity to evaluate such information in light of all surrounding facts, circumstances, recommendations and analyses. A number of results and uncertainties could cause actual results to differ materially from those in the forward-looking statements: CTI BioPharma’s NDA requesting accelerated approval for pacritinib may not be accepted by the FDA; additional pre-approval trials or post-approval Risk Evaluation and Mitigation Strategy (REMS) or Post-Marketing Requirements (PMR) may be required; satisfaction of regulatory and other requirements; clinical trial results; changes in laws and regulations; product quality, product efficacy, trial design and study protocol, data integrity, dataset size, patient safety issues, the smaller population size for the specific patient population; product development risks; and other risks identified in each issuer’s most recent filings on Form 10-K and other Securities and Exchange Commission filings. Except as required by law, CTI BioPharma undertakes to update its forward-looking statements.

CTI BioPharma Contact:
Monique Greer
206-272-4343
mgreer@ctibiopharma.com

(ZAGG) Debuts InvisibleShield Glass Luxe and Accessories for New Apple iPhones

ZAGG Offers Leading Screen Protection, Keyboards, Audio and Power Accessories for the New iPhone 6s and iPhone 6s Plus.

SALT LAKE CITY, Sept. 10, 2015  — ZAGG Inc (NASDAQ:ZAGG), a leading global mobile accessories company, announces a full range of accessories for the newest Apple smartphones, the iPhone™ 6s and iPhone 6s Plus. From top-selling screen protection and mobile keyboards to award-winning backup batteries and audio gear, Zagg is the leading brand for protecting and enhancing the iPhone experience.

“Zagg products are designed to bring out the best in Apple iPhones,” said Randy Hales, chief executive officer for Zagg. “Having the top-selling screen protection and keyboards as well as Zagg’s full range of power, audio, and cases have made us the go-to expert for outfitting Apple’s amazing phones and tablets.”

Along with its industry-leading InvisibleShield® HDX and InvisibleShield Glass screen protection, Zagg is introducing the InvisibleShield Glass Luxe^TM, which features enhanced, edge-to-edge durability and a seamless look from a polycarbonate border and high quality tempered glass shield. The glass maintains an ultra-smooth feel and precision touch sensitivity, ideal for the 3D Touch interactivity of the iPhone 6s and iPhone 6s Plus screens. Glass Luxe is available in multiple colors to accent the newly introduced smartphones.

All InvisibleShield products for the iPhone feature patented EZ Apply™ tabs for quick, easy application, and come with a lifetime guarantee. The InvisibleShield line includes:

• InvisibleShield Glass Luxe: Made of premium tempered glass and surrounded by a polycarbonate border, it provides edge-to-edge protection with maximum image clarity, an ultra-smooth feel, tapered edges, and remarkable touch sensitivity; available in coordinating with the new iPhones.
• InvisibleShield HDX: Features HD clarity and three-times greater shatter protection than most industry-leading phone glass. The InvisibleShield HDX also offers EZ Apply tabs for quick and simple application.
• InvisibleShield Glass: Made from multiple premium protective layers, including tempered scratch-resistant glass, it delivers ultimate image clarity with a silky smooth feel and unique tapered edges.

Zagg has a full range of accessories to complement the various Apple iPhone models. Examples include the Pocket Keyboard — the first mobile Bluetooth keyboard designed for smartphones — and a full range of power and audio products including the GoLite 2.0 and ZR-Six Earbuds. All Zagg’s accessories are available online at www.zagg.com or through Zagg’s select retail partners.

iPhone is a trademark of Apple Inc.

About ZAGG Inc:

ZAGG Inc (NASDAQ:ZAGG) creates best-in-class accessories that protect and enhance mobile devices for consumers around the globe. The company offers a broad range of products, from the No. 1 selling industry-standard InvisibleShield® screen protectors and mobile keyboards, to power management solutions, mobile audio, and cases. Zagg is the trusted brand that makes products consumers can rely on to make the most of their mobile lives. More information about the company and its brands, including iFrogz®, is available at www.zagg.com or on Facebook and Twitter.

CONTACT: Investor Relations:
         ZAGG Inc
         Kim Rogers
         801-506-7008
         kim.rogers@zagg.com

         Media:
         Edelman
         Jillian Gerig
         415-486-3222
         jillian.gerig@edelman.com

         Company:
         ZAGG Inc
         Nathan Nelson
         801-506-7341
         nnelson@zagg.com

(ACRX) European Commission Marketing Authorization for Zalviso

Approval triggers $15 million milestone payment to AcelRx from Grunenthal

REDWOOD CITY, Calif., Sept. 22, 2015  — AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) (AcelRx) announced today that the European Commission (EC) has approved Zalviso™ (15 micrograms sufentanil sublingual tablets) for the management of acute moderate-to-severe post-operative pain in adult patients. The marketing authorization is granted for the 28 EU member states as well as for the European Economic Area (EEA) countries, Norway, Iceland and Liechtenstein. Zalviso is a system combining a drug and a device designed to deliver a sublingual tablet formulation of sufentanil 15 mcg via a proprietary, pre-programmed, non-invasive, patient-controlled analgesia (PCA) device. Grunenthal Group, AcelRx’s licensee in Europe and Australia, expects the product to be available to Western European patients in the first half of 2016.

“This is a significant event for AcelRx. Not only is this the Company’s first marketing approval, but it represents the successful development and commercialization of a product that we believe will provide a new way for physicians and their patients to treat acute moderate-to-severe post-operative pain using an innovative delivery method,” stated Howie Rosen, interim chief executive officer of AcelRx Pharmaceuticals. “Our partner Grunenthal will be working with the member states of the EU and EEA to ensure that Zalviso is made available to those patients who would benefit from an effective and reliable solution for their moderate-to-severe post-surgical pain.”

Zalviso is designed to offer sustained (for up to 72 hours) and reliable pain relief for acute moderate-to-severe post-operative pain. In a Phase 3 clinical trial in patients who had undergone major joint replacement or open abdominal surgery, a higher percentage of study participants who self-administered Zalviso over a 48-hour period rated the method of pain control “good” or “excellent” compared to those using intravenous (IV) morphine PCA (p=0.007). Moreover, patients surveyed in this study rated their overall ease of care (p<0.001) and overall satisfaction (p=0.004) with Zalviso as higher than with IV morphine PCA. Zalviso was also rated by nurses to provide higher treatment satisfaction (p<0.001) and overall ease of care (p=0.017) compared with IV morphine PCA. Adverse events reported in the study were generally mild or moderate in nature and similar in both placebo and treatment groups, however fewer patients using Zalviso™ experienced oxygen desaturation episodes < 95% (p=0.028).

Dott. Alberto Grua, chief commercial officer Europe, Australia, North America & Global Product Supply (CCO EU, AUS, NA & GPS) from Grunenthal, adds, “We are delighted to bring a new, innovative way to manage post-operative pain to European healthcare professionals and patients. By combining the benefits of patient-controlled analgesia with those of a non-invasive route of administration, Zalviso offers a unique solution to address unmet needs of adult patients suffering from acute moderate-to-severe post-operative pain.”

On an annual basis, there are 19 million surgical procedures with associated acute moderate-to-severe post-operative pain in the European Union. A recent German survey in patients after surgery has shown that 55% of all patients are not satisfied with their treatment for post-operative pain¹. Even more so, 30% mention that their pain management has been inadequately effective [¹ Maier C et al. Dtsch Arztebl Int. 2010; 107; 607-614].

About Zalviso
Zalviso is an innovative pre-programmed, non-invasive, handheld system that allows hospital patients with acute moderate-to-severe post-operative pain to self-dose with sufentanil sublingual tablets, 15 mcg, to manage their pain. The system is designed to help address certain problems associated with post-operative analgesia, such as the drug-related side effects and delayed analgesic effect of morphine, the invasive intravenous (IV) route of delivery of current systems for patient-controlled analgesia (PCA) and the complexity of infusion pumps used for IV PCA delivery.

Grunenthal holds the rights for Zalviso in Europe and Australia while AcelRx retains all rights in North America, Asia, Latin America and Middle East/Africa. Under the terms of the collaboration, Grunenthal is responsible for maintaining the regulatory approval for the drug product and all commercial activities for Zalviso, in the Grunenthal territory. AcelRx will be responsible for maintaining device regulatory approval in the Grunenthal territory, as well as manufacturing and supply of Zalviso to Grunenthal for commercial sales and clinical trials.

About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain. In the US, the Company’s late-stage pipeline includes ARX-04 (sufentanil sublingual tablet, 30 mcg) for the treatment of moderate-to-severe acute pain in a medically supervised setting; and Zalviso (sufentanil sublingual tablet system) for the management of moderate-to-severe acute pain in adult patients in the hospital setting.

ARX-04 delivers 30 mcg sufentanil sublingual, a high therapeutic index opioid, through a disposable, pre-filled, single-dose applicator (SDA). AcelRx has reported positive results from the pivotal Phase 3 SAP301 ambulatory surgery study, and will be advancing ARX-04 into a study in emergency room patients in 2015. Zalviso delivers 15 mcg sufentanil sublingual tablets through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. Zalviso is approved in the EU as well as Norway, Iceland and Liechtenstein and is in late-stage development in the U.S. In response to the New Drug Application (NDA) AcelRx submitted to the U.S. Food and Drug Administration (FDA) seeking approval for Zalviso, the Company received a Complete Response Letter (CRL) on July 25, 2014. The FDA has requested an additional clinical study prior to the resubmission of the Zalviso NDA.

The Company has two additional pain treatment product candidates, ARX-02 and ARX-03, which have completed Phase 2 clinical development. For additional information about AcelRx’s clinical programs, please visit www.acelrx.com.

Forward Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the timing of any commercial launch of Zalviso; commercial success of Zalviso in the market place, the therapeutic and commercial potential of AcelRx Pharmaceuticals’ product candidates, including Zalviso and ARX-04, the process and timing of anticipated future development of AcelRx’s product candidates, including Zalviso and ARX-04, and any regulatory approval of AcelRx product candidates in the US.

These forward-looking statements are based on AcelRx Pharmaceuticals’ current expectations and inherently involve significant risks and uncertainties. AcelRx Pharmaceuticals’ actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to: therapeutic and commercial potential for AcelRx Pharmaceuticals’ product candidates, including Zalviso and ARX-04; ability to complete Phase 3 development for ARX-04, file an NDA and to receive regulatory approval for ARX-04; the success, cost and timing of all product development activities and clinical trials, including the Phase 3 ARX-04 trial. AcelRx Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.

(OPGN) to Present Data on Acuitas for Investigating Transmission of “Super Bugs”

Acuitas Resistome Test and Whole Genome Sequence Analysis Showcased at American Society for Microbiology Conference on Next Generation Sequencing for Epidemiologic Investigation of Pathogens

GAITHERSBURG, Md., Sept. 22, 2015  — OpGen, Inc. (NASDAQ:OPGN) today announced that data on its Acuitas^® Resistome Test and Acuitas Whole Genome Sequence (WGS) Analysis for multidrug-resistant organisms (MDROs) will be presented at the American Society for Microbiology’s First Conference on Rapid Next-Generation Sequencing and Bioinformatic Pipelines for Enhanced Molecular Epidemiologic Investigation of Pathogens, to be held from September 24 to 27 in Washington, D.C.

Terry Walker, OpGen Senior Vice President of Research and Development and a presenter at the OpGen-sponsored symposium at the ASM conference, said, “Our symposium presentation and three posters underscore our technologies’ rapid and highly accurate approach to determine the genetic variability underlying multidrug resistant organisms, and how to use that variability to investigate transmission events, help stop spread, and prevent outbreaks.”

Dr. Walker’s presentation, entitled “High Resolution Genomic Analysis of Multidrug-Resistant Organisms using Acuitas Resistome Test and Whole Genome Sequence Analysis,” is scheduled for September 25 at 12:00 p.m. EDT in the Capitol Room at the Omni Shoreham Hotel. The lunch symposium will review the two Acuitas tests and demonstrate OpGen’s Whole Genome Sequencing capabilities for epidemiologic investigations by analyzing thousands of genes and show the triaging utility of the Acuitas Resistome Test, saving time and reducing costs associated with high resolution analysis.

The three posters will be on display September 25 and 26. Details are as follows:

1. “Acuitas Resistome Test—a high-throughput triage tool for strain typing by whole genome sequencing.” Genotype resolution of OpGen’s Acuitas Resistome test examines its utility as a hospital triage tool to determine transmission events and possible treatments.

2. “MLST+ strain typing of multidrug-resistance organisms (MDROs) using Acuitas Whole Genome Sequence Analysis.” OpGen’s Acuitas WGS Analysis was used to create MLST+ schemas for eight species of drug-resistant bacteria.

3. “Comprehensive analysis of antibiotic resistance in multidrug-resistant organisms (MDROs) by whole genome sequencing using Acuitas Whole Genome Sequence Analysis.” OpGen’s Acuitas WGS Analysis was used to test a new database of all beta-lactamase genes to determine antibiotic resistance in multidrug-resistance organisms.

About MDROs

Multi-drug resistant organisms (MDROs) are common bacteria that have developed resistance to multiple classes of antibiotics. They are a leading cause of hospital-acquired infections and are associated with an increase in morbidity and mortality. Each year, more than two million Americans acquire infections that are resistant to antibiotics and of those, 23,000 will die of those infections. Asymptomatic carriers are at a higher risk of an MDRO infection and become reservoirs for transmission to other patients in health care systems if not accurately identified early. Since there are many types of antibiotic resistant organisms, and the way they cause disease is dictated by their genetics, knowing the exact genetic profile of these organisms is a key step to preventing their ability to infect.

About OpGen

OpGen, Inc. is an early commercial-stage molecular testing and bioinformatics company focused on assisting healthcare providers to combat multi-drug resistant organism (MDRO) bacterial infections – “Superbugs.” The Company is addressing this growing public health threat by rapidly delivering precise, actionable information to help identify, combat, and prevent the spread of these complex infections that jeopardize the safety of our hospitals and other long-term care facilities. OpGen offers a full portfolio of Acuitas® products including the MDRO Gene Test, the Resistome Test, microbial Whole Genome Sequence Analysis, Acuitas Lighthouse™ MDRO Management System and QuickFISH™, a suite of FDA-cleared and CE-marked diagnostics for rapid molecular testing of positive blood cultures designed to assure appropriate antibiotic therapy.  Learn more at www.opgen.com

OpGen Forward-Looking Statements 

This press release includes statements relating to the company’s products and services. These statements and other statements regarding our future plans and goals 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, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, the rate of adoption of our products and services by hospitals, the success of our commercialization efforts, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with OpGen’s business, please review our filings with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

CONTACT: OpGen
         Michael Farmer
         Director, Marketing
         (240) 813-1284
         mfarmer@opgen.com
         InvestorRelations@opgen.com

         Investors
         LHA
         Kim Sutton Golodetz
         (212) 838-3777
         kgolodetz@lhai.com

         or

         Bruce Voss
         (310) 691-7100
         bvoss@lhai.com

         Media
         Lisa Guiterman
         (301) 217-9353
         lisa.guiterman@gmail.com

(CETX) Sees Surge in Demand for its IS 2500 In-Situ NDIR Multi Gas Analyzer

Cemtrex (NASDAQ: CETX) announced today that it is seeing a surge in demand for its innovative IS 2500 Multi Gas Analyzer. The company has received multitude of orders from a diverse set of companies around the world for its proprietary state of the art emissions monitoring analyzer.

The IS 2500 Multi Gas Analyzer is an In-situ stack mounted emissions monitoring system that can measure several process gases at a fraction of the cost of comparable extractive systems. Due to recent advances in technology, Cemtrex has made it possible to have a low cost in-situ type analyzer instead of an expensive extractive type system that can deliver precise measurements of methane, carbon dioxide, oxygen, nitrogen oxides, carbon monoxide and others. The IS 2500 has a plethora of applications in virtually all manufacturing and industrial trades, from large utilities to small asphalt plants.

Cemtrex’ CEO, Saagar Govil, commented, “In many emerging economies, companies cannot afford a high priced extractive system so they are looking for our high-quality economical alternative. With the IS 2500 we have delivered exactly that. I am pleased to say that we are expanding our production capability to keep up with the strong demand.”

According to a recent report from McIlvane & Co., the worldwide CEMS market is around $1.2B with the majority of growth to be in emerging markets over the next five years.

About Cemtrex, Inc.

Cemtrex, Inc. (NASDAQ:CETX) is a world leading diversified industrial and manufacturing company that provides a wide array of solutions to meet today’s technology challenges. Cemtrex provides manufacturing services of advanced custom engineered electronics, emission monitors & instruments for industrial processes, and environmental control & air filtration systems for industries & utilities.
www.cemtrex.com

Safe Harbor Statement

This press release contains forward-looking statements. Actual results could differ materially from those projected in the forward-looking statements as a result of a number of risks and uncertainties. These forward looking statements are not a guarantee of future performance. This release may contain Non-GAAP financial information and are not calculated or presented in accordance with US GAAP. The Company believes that the presentation of non-GAAP financial measures provides useful information to management and investors regarding underlying trends in its consolidated financial condition and results of operations. The Company’s management regularly uses these supplemental non-GAAP financial measures internally to understand, manage and evaluate the Company’s business and make operating decisions. These risks and uncertainties are discussed in our filings with the Securities and Exchange Commission, including our annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date. Except as may be required by applicable securities laws, we do not undertake any obligation to revise or update any forward-looking statements contained in this release.

(HRTX) Positive Top-Line Results from Phase 2 Study of HTX-011

Heron Therapeutics, Inc. (NASDAQ: HRTX), a biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs, today announced positive, top-line results from its Phase 2 clinical study of HTX-011 in the management of post-operative pain in patients undergoing bunionectomy. HTX-011, which utilizes Heron’s proprietary Biochronomer^® drug delivery technology, is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam. The primary and all key secondary endpoints in the study were met with a high degree of statistical significance.

This randomized, placebo-controlled, double-blind, Phase 2 clinical study in 64 patients undergoing bunionectomy evaluated the efficacy and safety of HTX-011, containing 200 mg or 400 mg of bupivacaine combined with meloxicam, compared to placebo. The primary endpoint was the difference as compared to placebo in pain intensity as measured by the Summed Pain Intensity (SPI) score in the first 24 hours post-surgery (SPI 0-24). Key secondary endpoints included: the difference in SPI in the first 48 hours post-surgery (SPI 0-48); the difference in SPI in the first 72 hours post-surgery (SPI 0-72); time to the first use of opiate rescue medication; and the percent of patients who received no opiate rescue medication in the first 72 hours post-surgery. The study’s major efficacy findings for the more effective, 400 mg dose of HTX-011 as compared to placebo include:

• Pain intensity in the first 24 hours post-surgery was reduced by 69% (SPI of 38.5 versus 124.2, p<0.0001).
• Pain intensity in the first 48 hours post-surgery was reduced by 52% (SPI of 106.9 versus 224.8, p<0.0001).
• Pain intensity in the first 72 hours post-surgery was reduced by 40% (SPI of 170.2 versus 285.9, p=0.0064).
• Time to the first use of opiate rescue medication was increased by 488% (48.2 hours versus 8.2 hours, p<0.0001).
• 32% of patients received no opiate rescue medication during the entire 72-hour period post-surgery, compared to 5% for placebo (p<0.0001).

HTX-011 was generally well tolerated in the study. The most frequent adverse events reported were headache, nausea, vomiting, erythema, cellulitis, dizziness, and hypoxia, none of which were considered drug-related.

“Although opioid analgesics are standard of care for post-operative pain management, too often they are associated with unacceptable adverse effects often prolonging hospitalization and recovery,” stated Jeffrey A. Gudin, MD, Director, Pain Management and Palliative Care, Englewood Hospital and Medical Center, Englewood, NJ. “Thus, there is a major unmet need for a pain management treatment that can substantially reduce our dependence on post-operative opioids. The ability of HTX-011, administered once during surgery, to significantly reduce pain and the need for pain medications for three days following surgery (as compared to a control group) is truly promising.”

“At Heron, we are dedicated to the development of best-in-class medicines that can have a major impact on patients’ lives,” commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. “We are very pleased with these results, and we now will turn our attention to executing on a broad-based development program designed to enable us to bring HTX-011 to the many patients undergoing a wide range of surgeries who experience significant post-operative pain.”

Conference Call and Webcast

Heron Therapeutics will host a conference call and webcast on Wednesday, September 23 at 8:30 a.m. ET (5:30 a.m. PT). The conference call can be accessed by dialing (877) 311-5906 for domestic callers and (281) 241-6150 for international callers. Please provide the operator with the passcode 46461973 to join the conference call. The conference call will also be available via webcast under the investor relations section of Heron’s website at www.herontx.com and will be archived there for 90 days following the call. Please connect to Heron’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

About HTX-011 for Post-Operative Pain

HTX-011, which utilizes Heron’s proprietary Biochronomer^® drug delivery technology, is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the prevention of post-operative pain. By delivering sustained levels of both a potent anesthetic and an anti-inflammatory agent directly to the site of tissue injury, HTX-011 was designed to deliver superior pain relief while potentially reducing the need for systemically administered pain medications such as opioids, which carry the risk of harmful side effects, abuse and addiction. In September 2015, Heron reported positive top-line results from a Phase 2 study of HTX-011 in patients undergoing bunionectomy. In this study, HTX-011 significantly reduced pain intensity, significantly reduced the need for opioid rescue medications, and significantly increased the time to first use of rescue medications. HTX-011 is the subject of a broad-based development program designed to target the many patients undergoing a wide range of surgeries who experience significant post-operative pain.

About Heron Therapeutics, Inc.

Heron Therapeutics, Inc. is a biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents. Heron’s goal is to build on therapeutics with well-known pharmacology by improving their tolerability and efficacy as well as broadening their potential field of use. Heron is currently developing four pharmaceutical products for patients suffering from cancer or pain. SUSTOL^® (granisetron) Injection, extended release is being developed for the prevention of both acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). CINV is one of the most debilitating side effects of chemotherapy and is a leading cause of premature discontinuation of cancer treatment. Heron recently reported positive, top-line results from its Phase 3 MAGIC study. In July 2015, Heron resubmitted its New Drug Application (NDA) for SUSTOL to the U.S. Food and Drug Administration (FDA), and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016. HTX-019, also being developed for the prevention of CINV, has the potential to become the first polysorbate 80-free, intravenous formulation of aprepitant, a neurokinin-1 (NK₁) receptor antagonist. Heron intends to file an NDA for HTX-019 using the 505(b)(2) regulatory pathway in the second half of 2016. HTX-011 is Heron’s long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam. In September 2015, Heron reported positive, top-line results from a Phase 2 study of HTX-011 in patients undergoing bunionectomy. In this study, HTX-011 significantly reduced pain intensity and the need for opioid rescue medications. HTX-011 is the subject of a broad-based development program designed to target the many patients undergoing a wide range of surgeries who experience significant post-operative pain. HTX-003, a long-acting formulation of buprenorphine, is being developed for the potential management of chronic pain and opioid addiction. All of Heron’s product candidates utilize Heron’s innovative science and technology platforms, including its proprietary Biochronomer^® drug delivery technology, which can deliver therapeutic levels of a wide range of otherwise short-acting pharmacological agents over a period of days to weeks with a single injection.

For more information, please visit www.herontx.com.

Forward Looking Statements

This news release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management’s expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, but are not limited to, those associated with: whether the U.S. Food and Drug Administration (FDA) approves the SUSTOL NDA as submitted or supports as broad of a labeled indication for SUSTOL as requested, the progress in the research and development of HTX-019, HTX-011, HTX-003 and our other programs, including the timing of preclinical, clinical, and manufacturing activities, safety and efficacy results from our studies that may not justify the pursuit of further development of our product candidates, the launch and acceptance of SUSTOL and new products generally, our financial position and our ability to raise additional capital to fund operations, if necessary, or to pursue additional business opportunities, strategic business alliances we may pursue or the potential acquisition of products or technologies, and our ability to grow our organization to sustain the commercial launch for SUSTOL, and other risks and uncertainties identified in the Company’s filings with the Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.

Heron Therapeutics, Inc.
Investor Relations Contact:
Jennifer Capuzelo, 858-703-6063
Associate Director, Investor Relations
jcapuzelo@herontx.com
or
Corporate Contact:
Barry D. Quart, Pharm D., 650-366-2626
Chief Executive Officer

(ISCO) Names Ms. Ebrahimi as Chief Financial Officer

(LATX) Multi-Dimensional Entertainment Eatery Partnership With MyCheck

Partnership Includes Development of a First of Its Kind Add to Order & Pay by Phone Custom App With Full Loyalty Rewards Integration; Arrangement Will Extend to Current and Future Locations

(CVSL) Your Inspiration At Home Wins 92 Additional Gourmet Medals

DALLAS and GOLD COAST, Australia, Sept. 21, 2015  — Your Inspiration At Home continued its winning streak in international food competitions by collecting another round of prestigious gourmet food awards, further adding to the company’s growing list of honors.

Your Inspiration At Home was recently presented with three Champion & Reserve Champion Awards at the recent 2015 Royal Agriculture Society of Tasmania Fine Food Awards. The prestigious gourmet food awards in Australia judged Your Inspiration At Home’s Pumpkin Fiesta-Taste of Mexico as the overall Herb & Spice Category Champion.  A total of 92 Fine Food Medals were awarded to Your Inspiration At Home.

These latest awards follow three medals recently presented at the 2015 Royal Melbourne Fine Food Awards, also in Australia.

Your Inspiration At Home is a member of the CVSL Inc. family of direct-to-consumer companies [NYSE MKT: CVSL] www.cvsl.us.com.

Since 2011, Your Inspiration At Home has been honored with 370 Fine Food Awards, including a total to-date of ten Champion & Reserve Champion Awards for ‘Best-in-Class’.

Founder, CEO & Spice Curator™ of Your Inspiration At Home, Colleen Walters, was presented the honor while the company celebrated its 2015 Australian Convention at the Gold Coast, Australia.

“I am astounded and humbled year after year to see these results of our work,” commented Ms. Walters. “It was especially amazing to have Mr. Robert Wallace from the Royal Hobart Fine Food Awards attend our Annual Gala Awards event and share these successes with our convention attendees,” she added.

Your Inspiration At Home’s annual event showcased several new programs, including the Flavour Stack™, a monthly subscription-style platform of a diverse range of herb and spice products focused on specific gourmet recipes.  Each Flavour Stack recipe is designed as a meal for four people.

“The Flavour Stack™ program is designed to let our customers create simple gourmet recipes by adding fresh groceries and pantry items to the portion-sized Your Inspiration At Home products.  It’s quick, easy and perfectly shows our global gourmet experience philosophy,” said Ms. Walters.

About Your Inspiration At Home

Your Inspiration At Home (www.yourinspirationathome.com.au) is an award-winning maker of hand-crafted spices and other gourmet food items from around the world. Independent Your Inspiration At Home Consultants sell directly to customers around the world, in markets including Australia, New Zealand, the United States and Canada.

About CVSL Inc.

CVSL Inc. [NYSE MKT: CVSL] is a growing platform of direct-to-consumer brands. Within CVSL, each company retains its own separate brand identity, sales force and compensation plan. CVSL companies currently include The Longaberger Company, a 42-year old maker of hand-crafted baskets and other home decor items; Your Inspiration At Home, an award-winning maker of hand-crafted spices and other gourmet food items from around the world; Tomboy Tools, a direct seller of tools designed for women as well as home security systems; Agel Enterprises, a global seller of nutritional products in gel form as well as a skin care line, operating in 40 countries; Paperly, which offers a line of custom stationery and other personalized products; My Secret Kitchen, a U.K.-based seller of gourmet food products; Uppercase Living, which offers an extensive line of customizable vinyl expressions for display on walls in the home; and Kleeneze, a UK-based seller of cleaning, health, beauty, home, outdoor and a variety of other products. CVSL also includes Happenings, a lifestyle publication and marketing company.

Cautionary Note Regarding Forward-Looking Statements:

This press release contains forward-looking statements that involve risks and uncertainties. All statements other than statements of historical fact contained in this press release are forward-looking statements. We have attempted to identify forward-looking statements by terminology including “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” or “will” or the negative of these terms or other comparable terminology. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. These statements are based upon current beliefs, expectations and assumptions and include statements regarding CVSL being a growing platform of direct-to-consumer brands  and the other risks outlined under “Risk Factors” in CVSL’s Annual Report on Form 10-K/A for its fiscal year ended December 31, 2014 and those risks discussed in other documents we file with the Securities and Exchange Commission, which may cause our actual results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements to differ materially from expectations. Except as required by law, we undertake no obligation to update or revise publicly any of the forward-looking statements after the date of this press release to conform our statements to actual results or changed expectations.

CVSL Investor Relations Contact: Tucker Gagen (tucker.gagen@cvsl.us.com)
CVSL Media Contact: Russell Mack (rmack@cvsl.us.com)

(ANIP) to Acquire Two NDAs from Merck for $75 Million

Transaction Highlights: – Corticotropin, 40 units/mL and 80 units/mL, NDA #008975 – Corticotropin-zinc hydroxide, 40 units/mL, NDA #009854 – Assets will be acquired by foreign subsidiary to achieve more favorable tax treatment for ANI – Acquisition significantly advances ANI’s core strategy of re-commercializing previously approved products Conference call to discuss transaction scheduled today at 10:00am ET Dial in number: (855) 582-8078; conference ID: 43851450

BAUDETTE, Minn., Sept. 21, 2015  — ANI Pharmaceuticals, Inc. (“ANI”) (NASDAQ: ANIP) today announced that it has agreed to acquire the NDAs for purified corticotropin gel and corticotropin-zinc hydroxide from Merck (known as MSD outside of the United States and Canada) for $75 million in cash and a percentage of future net sales. ANI estimates that the current annual U.S. market for the products it is acquiring is approximately one billion dollars as evidenced by sales of H.P. Acthar^® gel marketed by Mallinckrodt Pharmaceuticals. The acquisition is being funded through cash on hand and is subject to certain customary closing conditions.

Corticotropin gel is a purified corticotropin (ACTH) in a sterile solution of gelatin for prolonged activity. Corticotropin-zinc hydroxide (sterile corticotropin zinc hydroxide suspension USP) is a sterile aqueous suspension of purified corticotropin (ACTH) with zinc hydroxide for repository action. The products are approved for various disease states including Multiple Sclerosis, Rheumatic disorders, Dermatologic diseases, and a variety of Collagen, Ophthalmic, Respiratory diseases as well as Allergic and Edematous states.

As part of its acquisition strategy, ANI has determined to pursue the formation of one or more foreign subsidiaries to effect its acquisitions, manufacture products and/or provide other ancillary services. It is expected that this acquisition from Merck will be effected through one of such subsidiaries. It is anticipated that this will enable ANI to achieve a lower over-all tax rate for its operations.

ANI will host a conference call to discuss the transaction at 10:00am eastern time today. The call will be open to the public and can be accessed through a conference line by dialing (855) 582-8078. The conference ID is 43851450.  A recording of the conference call will be available within two hours of the completion of the call and will remain accessible for a period of seven days following the call. To access the replay, dial (855) 859-2056. The access code for the replay is 43851450. This press release and a slide presentation have been posted to the Investor Relations section of the Company’s website, www.anipharmaceuticals.com.

Arthur S. Przybyl, President and CEO of ANI Pharmaceuticals stated, “This acquisition is intended to enable us to compete in a one billion dollar branded market alongside H.P. Acthar^® gel.  We are confident in our ability to re-commercialize these products.”

Robert W. Schrepfer, VP Business Development of ANI Pharmaceuticals, commented, “This represents a transformational opportunity for ANI that remains consistent with our strategy of acquiring and re-commercializing previously approved products.  We have added a unique and substantial opportunity to our expanding product pipeline and by establishing a new foreign platform we feel that ANI has set the stage for long term growth both organically and through future acquisitions.”

About ANI

ANI Pharmaceuticals, Inc. (the “Company” or “ANI”) is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. The Company’s targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products. For more information, please visit our website www.anipharmaceuticals.com.

Forward-Looking Statements

To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about price increases, the Company’s  future operations, products financial position, operating results and prospects , the Company’s pipeline or potential markets therefore, and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words and the use of future dates.

Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to, the risk that the Company may face with respect to importing raw materials; increased competition; delays or failure in obtaining product approval from the U.S. Food and Drug Administration; general business and economic conditions; market trends; products development; regulatory and other approvals and marketing.

More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as its proxy statement. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

For more information about ANI, please contact:
Investor Relations
IR@anipharmaceuticals.com

(TIPT) Fortegra™ to Offer Mobile Phone Protection to USAA Members

Fortegra, a Tiptree Financial Inc. company (NASDAQ:TIPT), today announces they will provide mobile phone protection products for members of USAA, a financial provider for the U.S. military and their families. Fortegra plans to create a specialized ProtectCELL mobile phone protection plan unique to USAA members, which delivers on the company’s promise to help partners and customers Experience More.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20150921005032/en/

“Fortegra and USAA have both built our brands on doing what is right for the customer, so we are perfectly aligned for an alliance,” said Fortegra Executive Vice President Joe McCaw. “We’re proud to work with USAA and welcome the opportunity to create an exclusive offering to fit the needs of our distinguished service members and their families.”

USAA members can protect any style smartphone with this newly designed ProtectCELL plan. Two-year, one-year, and monthly protection plans will be available for all mobile phone makes and models. Fortegra’s ProtectCELL plans include:

• Fortegra’s guaranteed ‘No Hassle’ experience
• SafeStore cloud storage – 50GB of shareable storage across 10 phones for photos, videos, contacts, and music
• SafeStore family security – remote locate, lock, and wipe for missing phones as well as other mobile security features

USAA members and employees can take advantage of these Fortegra offerings at USAA.com or by speaking with a USAA representative by phone. For more information on Fortegra and the company’s entire product lineup, visit fortegra.com.

About Fortegra
Fortegra, a subsidiary of Tiptree Financial Inc. (NASDAQ: TIPT), is a single source insurance services company that, through a network of preferred partners, offers a range of specialty program underwriting, credit protection, and warranty solutions. Delivering multi-faceted coverage with an unmatched service experience for both resellers and their customers, Fortegra solves immediate, everyday needs, empowering consumers to worry less and Experience More.

(BCOM) Expects to Receive Approximately NIS 286 Million in Dividends

B Communications Ltd. (Nasdaq and TASE: BCOM) (“B Communications”) announced today that on September 21, 2015 shareholders at the General Meeting of its controlled subsidiary, Bezeq – The Israel Telecommunications Corp., Ltd. (“Bezeq”), approved the payment of a dividend of NIS 933 million to Bezeq’s shareholders. The dividend, which is based on Bezeq’s dividend distribution policy, is expected to be paid on October 26, 2015. B Communications expects to receive approximately NIS 286 million (approximately US$ 74 million at current exchange rates) from this distribution.

“During the recent period, we continued to execute our business plan, by leveraging Bezeq’s stable platform, strong financial position and competitive advantages to create value for our shareholders and provide comfort to our debt investors,” said Doron Turgeman, CEO of B Communications. “In the past five years, we have focused aggressively on deleveraging, and now, with our balance sheet in good shape, we believe now is the right time to use the new dividend proceed in order to return capital to our shareholders while continuing maintain sufficient resources to service our debt.”

About B Communications Ltd.

B Communications is a holding company with a controlling interest in Israel’s largest telecommunications provider, Bezeq, The Israel Telecommunication Corp. (TASE: BEZQ). B Communications shares are traded on NASDAQ and the TASE under the symbol “BCOM.” For more information please visit the following Internet sites:

www.bcommunications.co.il

www.ir.bezeq.co.il

www.eurocom.co.il

www.igld.com

Forward-Looking Statements

This press release contains forward-looking statements that are subject to risks and uncertainties. Factors that could cause actual results to differ materially from these forward-looking statements include, but are not limited to, general business conditions in the industry, changes in the regulatory and legal compliance environments, the failure to manage growth and other risks detailed from time to time in B Communications’ filings with the Securities Exchange Commission. These documents contain and identify other important factors that could cause actual results to differ materially from those contained in our projections or forward-looking statements. Stockholders and other readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. We undertake no obligation to update publicly or revise any forward-looking statement.

(AWRE) Used By Digital Security Leader In Brazil To Offer Cloud-Based Biometrics

Certisign, the largest provider of digital certificates in Brazil, introduces biometric services to government and enterprise customers

BEDFORD, Mass., Sept. 21, 2015  — Aware, Inc. (NASDAQ: AWRE), a leading global provider of biometrics software products and solutions, today announced that a number of its products have been licensed by Certisign to build a cloud-based biometric services platform. Certisign is the largest supplier of digital certificates in Brazil. They intend to leverage their substantial presence in the Latin American security technology and services market to deliver new biometric identity proofing and authentication services. Targeted customers include banks, retailers, telecoms, healthcare providers, and government agencies that want to reduce fraud by more effectively authenticating the identity of their customers and employees, but prefer a software-as-a-service (SaaS) model.

The multi-tiered Certisign platform is built upon key Aware software products, including Biometric Services Platform (BioSP™), Nexa™, Inquire™, and Astra™. The enrollment and verification stations are branded by Certisign and were built using Aware’s NISTPack, SequenceCheck™, LiveScan API, PreFace™, and IrisCheck™ SDKs. The system is designed to be sufficiently scalable to meet high-volume service demands, while its modularity enables Certisign to support the varied requirements of a diverse customer base. Aware will receive a per-transaction fee for Certisign’s right to use Aware’s software in the system.

“The range and flexibility of Aware’s software helped make our new biometric services possible,” commented Igor Rocha, managing director of Certibio, the biometric business unit of Certisign. “Their deep expertise and reliable support are what we expect will help ensure our success.”

Biometric enrollment and identity proofing can be conducted either at a customer’s premises or at one of Certisign’s 1400+ retail locations. Biometric authentication is performed by customer staff using workstations installed at the location of their choice. Services can be deployed either from Certisign’s highly secure cloud, or alternatively from software installed in a private cloud or network.

“Certisign promises to make robust identity fraud prevention truly universally accessible throughout Brazil and beyond,” said Rob Mungovan, VP of Biometrics at Aware. “We are pleased to be providing the identity platform in a solution that will surely set a benchmark for consumer-facing biometrics-as-services.”

Aware will be demonstrating its biometrics software products and solutions at the Global Identity Summit, taking place September 21-24 in Tampa. Igor Rocha of Certibio will provide more information about their new services in a presentation at the Biometrics 2015 conference, taking place October 13-15 in London, where Aware will also be exhibiting.

About Aware
Aware is a leading provider of biometrics software products and development services to governments, system integrators, and solution providers globally. Our products include SDKs, software components, workstation applications, and a modular, centralized, service-oriented platform. They fulfill a broad range of functions critical to biometric authentication and search, including face, fingerprint, and iris autocapture, image quality assurance, data compliance, capture hardware peripheral abstraction, centralized data processing and workflow, subsystem connectivity, and biometric matching algorithms. The products are used to enable identity-centric security solutions with biometrics for applications including border management, credentialing and access control, intelligence and defense, and law enforcement. Aware is a publicly held company (Nasdaq: AWRE) based in Bedford, Massachusetts.

See Aware’s website for more information about our biometrics software products.

About Certisign
Certisign is the leading certification authority in Latin America and expert in digital identification. With 19 years of experience, 1,400 service points, and more than seven million digital certificates issued, in 2015 it expanded its participation in the identification market with the creation of Certibio.  The new business unit focuses exclusively on identity validation through biometrics, and offers the technology to customers using an innovative and pioneering model: biometrics-as-a-service. Certisign has in its portfolio of clients the most representative companies in Brazil, and is among the 50 Most Innovative Companies in the country, according to a survey conducted by DOM Strategy Partners. For more information, visit www.certisign.com.br.

Safe Harbor Warning

Portions of this release contain forward-looking statements regarding future events and are subject to risks and uncertainties, such as estimates or projections of future revenue and earnings, and the growth of the biometrics markets. Aware wishes to caution you that there are factors that could cause actual results to differ materially from the results indicated by such statements.

Risk factors related to our business include, but are not limited to: i) our operating results may fluctuate significantly and are difficult to predict; ii) we derive a significant portion of our revenue from government customers, and our business may be adversely affected by changes in the contracting or fiscal policies of those governmental entities; iii) a significant commercial market for biometrics technology may not develop, and if it does, we may not be successful in that market; iv) we derive a significant portion of our revenue from third party channel partners; v) hardware revenue is likely to decline in future periods; vi) we face intense competition from other biometrics solution providers; vii) our business is subject to rapid technological change; viii) our software products may have errors, defects or bugs which could harm our business; ix) our business may be adversely affected by our use of open source software; x) our intellectual property is subject to limited protection; xi) we may be sued by third parties for alleged infringement of their proprietary rights; xii) we must attract and retain key personnel; xiii) we rely on single sources of supply for certain components used in our hardware products; xiv) our business may be affected by government regulations and adverse economic conditions; xv) we may make acquisitions that could adversely affect our results, and xvi) we may have additional tax liabilities.

We refer you to the documents Aware files from time to time with the Securities and Exchange Commission, specifically the section titled Risk Factors in our annual report on Form 10-K for the fiscal year ended December 31, 2014 and other reports and filings made with the Securities and Exchange Commission.

Aware, BioSP, Nexa, Inquire, Astra, SequenceCheck, PreFace and IrisCheck are trademarks or registered trademarks of Aware, Inc.
Any other trademarks appearing herein are the property of their respective owners.

AWARE, INC.  •  40 MIDDLESEX TURNPIKE  •  BEDFORD, MA
USA  01730-1432
TEL: (781) 276-4000  •  FAX: (781) 276-4001  •  E-MAIL:
SALES@AWARE.COM

(SKYS) Strategic Partnership to Fund Up to $100 Million Into Solar Projects

HONG KONG, Sept. 21, 2015  — Sky Solar Holdings, Ltd. (NASDAQ:SKYS) (“Sky Solar” or the “Company”), a global developer, owner and operator of solar parks, and Hudson Clean Energy Partners (“Hudson”), a leading private equity firm specializing in renewable energy, today announced a new strategic partnership to fund solar projects in Latin America and Japan with a total capital commitment from Hudson of up to $100 million. The two parties have also agreed to collaborate on an expansion into the U.S. solar market.

As part of this partnership, Hudson will invest $50 million in the construction of approximately 128 megawatts of solar projects in Chile and Uruguay, and will receive a 49 percent minority equity stake in the projects upon their completion. Hudson has allocated an additional $50 million for secondary market opportunities in Japan, subject to due diligence and other necessary approvals. Beyond this capital commitment, both parties have agreed in principle to collaborate on identifying and acquiring suitable renewable assets in the United States.

“We are delighted to be working with a leading specialized private equity and infrastructure fund to develop shovel-ready projects in our key markets,” said Sanjay Shrestha, chief investment officer of Sky Solar and president of Sky Capital Americas. “In addition to the near-term capital investment, we believe Sky Solar will benefit from Hudson’s long tenure as an investor in the renewable energy sector and unmatched industry experience in this strategic partnership.”

“We are excited about our partnership with Sky Solar, a company with deep power development expertise and substantial global reach,” said Neil Z. Auerbach, founder and managing partner of Hudson. “They have developed a portfolio of high-quality solar projects in attractive markets such as Chile, Uruguay and Japan.”

About Sky Solar Holdings, Ltd.

Sky Solar is a global independent power producer (“IPP”) that develops, owns and operates solar parks and generates revenue primarily by selling electricity. Since its inception, Sky Solar has focused on the downstream solar market and has developed projects in Asia, South America, Europe, North America and Africa. The Company’s broad geographic reach and established presence across key solar markets are significant differentiators that provide global opportunities and mitigate country-specific risks. Sky Solar aims to establish operations in select geographies with highly attractive solar radiation, regulatory environments, power pricing, land availability, financial access and overall power market trends. As a result of its focus on the downstream photovoltaic segment, Sky Solar is technology agnostic and is able to customize its solar parks based on local environmental and regulatory requirements. As of June 30, 2015, the Company has developed 237 solar parks with an aggregate capacity of 215.0 MW and owned and operated 93.2 MW of solar parks.

About Hudson Clean Energy Partners

Hudson Clean Energy is a private equity and infrastructure firm dedicated exclusively to investing in renewable power and clean energy. The New Jersey-based firm was founded in 2007, and makes privately negotiated investments in infrastructure platforms, focused on the development, construction and operation of power plants, direct investments in power projects, as well as investments in the high-growth, asset-based, capital intensive segments of value chain companies that have manufacturing or servicing business. Hudson’s investment expertise spans across a variety of subsectors within the renewable energy industry including, solar and wind energy, biofuels, biomass, geothermal energy, energy efficiency and storage.

Safe-Harbor Statement

This press release contains forward-looking statements. These statements constitute “forward-looking” statements 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 as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends, “plans,” “believes,” “estimates” and similar statements. Among other things, the quotations from management in this press release and the Company’s operations and business outlook contain forward-looking statements. Such statements involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. These risks and uncertainties include, but are not limited to the following: the reduction, modification or elimination of government subsidies and economic incentives; global and local risks related to economic, regulatory, social and political uncertainties; global liquidity and the availability of additional funding options; the delay between making significant upfront investments in the Company’s solar parks and receiving revenue; expansion of the Company’s business into China; risk associated with the Company’s limited operating history, especially with large-scale IPP solar parks; risk associated with development or acquisition of additional attractive IPP solar parks to grow the Company’s project portfolio; and competition. Further information regarding these and other risks is included in Sky Solar’s filings with the U.S. Securities and Exchange Commission, including its annual report on Form 20-F. Except as required by law, the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: For Additional Information:

         Company:
         IR@skysolarholding.com

         Investor Relations:
         ICR, LLC
         Victor Kuo
         Phone: +86 (10) 6583-7526
         Victor.kuo@icrinc.com

         Hudson Clean Energy Partners:
         Eleni Polychroniadou
         Phone: +1 908-507-1221
         eleni@antennagroup.com

(IMGN) Webcast of Analyst & Investor Event on September 18

ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops novel anticancer therapeutics using its antibody-drug conjugate (ADC) technology, today announced that investors, journalists and the general public are invited to listen to a live webcast of the Company’s analyst and investor event on September 18, 2015.

The event will focus on ImmunoGen’s strong foundation for growth, including the advancement of its multi-product pipeline, its proprietary technology that is enabling the development of novel anticancer therapies and the Company’s core competencies that position it for success.

The video webcast will begin at 8:30 a.m. ET and will be accessible through the Investors section of the Company’s website, www.immunogen.com. The meeting is expected to last approximately three hours, including a short break. An archive of the webcast will be available on the Company’s website through October 2, 2015.

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells. The Company utilizes its ADC technology with its antibodies to create ImmunoGen product candidates and also out-licenses limited rights to use its technology to other companies. Roche’s Kadcyla^® is the first marketed product with ImmunoGen’s ADC technology. More information about the Company can be found at www.immunogen.com.

Kadcyla^® is a registered trademark of Genentech, a member of the Roche Group.

(HOTR) Goldman Small Cap Research Initiates Coverage of Chanticleer Holdings

BALTIMORE, September 17, 2015  —

Goldman Small Cap Research, a stock market research firm specializing in the small cap and microcap sectors, announced today that it has issued an initiation of coverage of report on Chanticleer Holdings, Inc. (NASDAQ – HOTR), a publicly traded company that owns and operates popular, fast casual dining brands. The report carries a rating and a price target. To view the new sponsored research report, along with disclosures and disclaimers, or to download them in their entirety, please visit http://www.GoldmanResearch.com.

Chanticleer Holdings owns and operates restaurant brands in the United States and internationally. The Company is a franchisee owner of Hooters® restaurants in international markets including Australia, South Africa, and Europe, and two Hooters restaurants in the United States. The Company also owns and operates American Burger Co., BGR the Burger Joint, BT’s Burger Joint, and owns a majority interest in Just Fresh restaurants in the U.S.

In the report, analyst Rob Goldman discusses the Company’s enviable growth history, the implementation of its business model and multiple brand strategy, along with its standing and valuation among the fast casual dining peer group.

“Chanticleer Holdings has successfully executed its operational and M&A strategy which has resulted in impressive revenue growth over the past few years. Not only has the Company generated high top-line growth among peers, but year-to-date it has recorded greater than average same-store-sales growth. Following the closing of its latest acquisition in the coming weeks, Chanticleer should be on track to achieve a key inflection point in terms of annual company revenue run-rate and restaurant-level EBITDA, which could favorably impact the Company’s overall valuation.”

About Goldman Small Cap Research: Founded in 2009 by former Piper Jaffray analyst and mutual fund manager Rob Goldman, Goldman Small Cap Research produces sponsored and non-sponsored small cap and microcap stock research reports, articles, daily stock market blogs, and popular investment newsletters. Goldman Small Cap Research is not in any way affiliated with Goldman Sachs & Co.

This press release contains excerpts of our most recently published sponsored research report on Chanticleer Holdings, Inc.  The information used and statements of fact made have been obtained from sources considered reliable but we neither guarantee nor represent the completeness or accuracy. Goldman Small Cap Research relied solely upon information derived from Chanticleer Holdings, Inc. (“the Company”) authorized press releases or legal disclosures made in its filings with the U.S. Securities and Exchange Commission http://www.sec.gov.

Separate from the factual content of our articles about the Company, we may from time to time include our own opinions about the Company, its business, markets and opportunities. Any opinions we may offer about the Company are solely our own, and are made in reliance upon our rights under the First Amendment to the U.S. Constitution, and are provided solely for the general opinionated discussion of our readers. Our opinions should not be considered to be complete, precise, accurate, or current investment advice. Statements herein may contain forward-looking statements and are subject to significant risks and uncertainties affecting results.

A Goldman Small Cap Research report, update, newsletter, article, or press release is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed is to be used for informational purposes only. Please read all associated full disclosures, disclaimers, and analyst background on our website before investing. Neither Goldman Small Cap Research nor its parent is a registered investment adviser or broker-dealer with FINRA or any other agency. To download our research, view our disclosures, or for more information, visit http://www.goldmanresearch.com. Goldman Small Cap Research has been compensated by a third party in the amount of $3500 for investment research services that includes the publication of a research report.

About Chanticleer Holdings.: Headquartered in Charlotte, NC, Chanticleer Holdings, Inc. (NASDAQ – HOTR) together with its subsidiaries, owns and operates restaurant brands in the United States and internationally. The Company is a franchisee owner of Hooters® restaurants in international markets including Australia, South Africa, and Europe, and two Hooters restaurants in the United States. The Company also owns and operates American Burger Co., BGR the Burger Joint, BT’s Burger Joint, and owns a majority interest in Just Fresh restaurants in the U.S. More information on HOTR can be found at http://www.ChanticleerHoldings.com.

Goldman Small Cap Research
Rob Goldman, Analyst
+1-410-609-7100
rob@goldmanresearch.com

(SQNM) National Coverage Agreement With UnitedHealthcare

SAN DIEGO, Sept. 17, 2015  — Sequenom Laboratories, a wholly owned subsidiary of Sequenom, Inc. (NASDAQ: SQNM), a life sciences company committed to enabling healthier lives through the development of innovative products and services, announced today that it has signed a national agreement with UnitedHealthcare Insurance Company, effective October 1, 2015, covering 43 million people throughout the United States, to provide the MaterniT21^® PLUS, HerediT^® CF Carrier Screen and HerediT^® UNIVERSAL Carrier Screen laboratory-developed tests (LDT). The addition of this contract brings the number of covered lives under agreement by Sequenom Laboratories’ diagnostic services to more than 200 million.

The MaterniT21 PLUS test reports on trisomy 21, 18, 13, 16 and 22, sex chromosome aneuploidies, fetal sex and select microdeletions in single or multifetal gestations as early as 10 weeks in a pregnancy. Estimates suggest there are about 750,000 pregnancies at high risk for fetal chromosomal abnormalities each year in the United States.

The HerediT CF Carrier Screening test analyzes the most clinically relevant mutations and variants related to cystic fibrosis. The HerediT UNIVERSAL Carrier Screening test is a comprehensive, customizable expanded test that screens for > 250 diseases and > 2,000 disease-causing mutations.

These tests are available exclusively through Sequenom Laboratories as testing services provided to health care professionals. To learn more about these tests, please visit www.laboratories.sequenom.com.

About Sequenom 

Sequenom, Inc. (NASDAQ: SQNM) is committed to enabling healthier lives through the development of innovative products and services. The Company serves patients and physicians by providing early patient management information. To learn how Sequenom is interpreting the genome to improve your life, visit www.sequenom.com.

About Sequenom Laboratories

Sequenom Laboratories^™, a CAP-accredited and CLIA-certified molecular diagnostics laboratory, has developed a broad range of laboratory tests, with a focus principally on prenatal care. Branded under the names HerediT^® CF, HerediT^® UNIVERSAL, VisibiliT^™, MaterniT21^® PLUS, MaterniT^™ GENOME, and NextView^™, these molecular genetic laboratory-developed tests provide early patient management information for obstetricians, geneticists, and maternal fetal medicine specialists.  Sequenom Laboratories is changing the landscape in genetic diagnostics using proprietary cutting edge technologies. Visit www.laboratories.sequenom.com and follow @SequenomLabs.

SEQUENOM^®, Sequenom Laboratories™, HerediT^® CF, HerediT^® UNIVERSAL, VisibiliT™, MaterniT21^® PLUS, MaterniT™ GENOME, and NextView™ are trademarks of Sequenom, Inc. All other trademarks and service marks are the property of their respective owners.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including the development of innovative products and services. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in the Company’s filings with the Securities and Exchange Commission, including without limitation the Company’s most recent Quarterly Report on Form 10-Q and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

(TGTX) SPA Agreement w/ FDA for Phase 3 Trial of Its Proprietary Combination Regimen of TG-1101

Novel Design Allows for Simultaneous Approval of Two Investigational Agents in a Single Phase 3 Study Under SPA

Study Will Include Both Front-Line and Previously Treated Patients With CLL

Interim Analysis Following Completion of Enrollment Could be Used to Support Accelerated Approval of the Combination of TG-1101 +TGR-1202

International Phase 3 Study Entitled “UNITY-CLL” to be Led by John Gribben, MD, PhD of Barts Cancer Institute, London, UK

NEW YORK, Sept. 17, 2015  — TG Therapeutics, Inc. (Nasdaq:TGTX) announced today that it has reached an agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 clinical trial for its proprietary combination of TG-1101 (ublituximab), its glycoengineered anti-CD20 monoclonal antibody, plus TGR-1202, the Company’s once-daily PI3K-delta inhibitor, for the treatment of Chronic Lymphocytic Leukemia (CLL). The SPA provides agreement that the Phase 3 trial design adequately addresses objectives that, if met, would support the regulatory submission for drug approval of both TG-1101 and TGR-1202 in combination.

Full details of the Phase 3 clinical trial, called the UNITY-CLL trial, will be released at the launch of the study. The general study design is a randomized controlled clinical trial that includes two key objectives: first, to demonstrate contribution of each agent in the TG-1101 + TGR-1202 regimen (the combination sometimes referred to as “1303”), and second, to demonstrate superiority in Progression Free Survival (PFS) over the standard of care to support the submission for full approval of the combination. The study will randomize patients into four treatment arms: TG-1101 + TGR-1202, TG-1101 alone, TGR-1202 alone, and an active control arm of obinutuzumab + chlorambucil. An early interim analysis will assess contribution of each single agent in the TG-1101 + TGR-1202 combination regimen, which, if successful, will allow early termination of both single agent arms. A second interim analysis will be conducted following full enrollment into the study, which, if positive, the Company plans to utilize for accelerated approval. Assuming early termination of the TG-1101 and TGR-1202 single agent arms, the study will enroll approximately 450 patients.

Dr. John Gribben, Professor of Medicine and the Gordon Hamilton Fairley Chair of Medical Oncology at St. Bartholomew’s Hospital, Barts Cancer Institute in London, UK, will lead the UNITY-CLL Phase 3 as Study Chair. Dr. Gribben commented, “The recent introduction of novel targeted agents has already dramatically improved the standard of care for patients with relapsed or refractory CLL, and we have seen even greater activity when these agents are used in combination. Both ublituximab and TGR-1202 have demonstrated unique activity and tolerability as single agents, and in combination together. We are excited to lead this important and innovative trial, which has the potential to bring greater advances to patients in both the front-line and relapsed/refractory CLL setting.”

Michael S. Weiss, Executive Chairman and Interim Chief Executive Officer of TG Therapeutics, stated, “Our number one goal has always been to accelerate the development of novel non-chemotherapy-based combination treatments for patients with B-cell malignancies. The UNITY-CLL study and the related SPA marks a major milestone for the Company and, if successful, could lead to a very broad label in the treatment of CLL, providing patients and physicians a new treatment option, and the Company a platform to build additional proprietary combinations in our continued effort to drive towards a cure. Our path to achieving this SPA, which we believe is the first for two novel investigational agents in the oncology division, was the result of a true collaboration with the FDA, for which we would like to recognize and thank the agency for its invaluable guidance throughout this process.” Mr. Weiss continued, “Our clinical team has been hard at work preparing for the launch of this study, and we look forward to enrolling our first patients as soon as possible. Lastly, we are thrilled to have Dr. Gribben, a world-renowned authority in CLL, lead this important international study and share in his excitement in bringing our novel, non-chemotherapy combination regimen to patients in need.”

ABOUT TG THERAPEUTICS, INC.

TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the Company is developing two therapies targeting hematological malignancies. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies. The Company also has pre-clinical programs to develop IRAK4 inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City.

About Special Protocol Assessments

The Special Protocol Assessment (SPA) process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a new drug application.

Final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 clinical program. The SPA agreement may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety. For more information on Special Protocol Assessment, please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf.

Cautionary Statement

Some of the statements included in this press release, particularly those with respect to anticipating future clinical trials, the timing of commencing or completing such trials and business prospects for TG-1101, TGR-1202, the IRAK4 inhibitor program, and the anti-PD-L1 and anti-GITR antibodies may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete pre-clinical and clinical trials for TG-1101, TGR-1202, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies; the risk that early pre-clinical and clinical results that supported our decision to move forward with TG-1101, TGR-1202, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies will not be reproduced in additional patients or in future studies; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 will not continue, the risk that TGR-1202 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current Phase 1 study; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior pre-clinical and clinical trials; the risk that trials will take longer to enroll than expected; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

TGTX – G

CONTACT: Jenna Bosco
         Director- Investor Relations
         TG Therapeutics, Inc.
         Telephone: 212.554.4351
         Email: ir@tgtxinc.com

(CDOR) Cancels Special Meeting of Shareholders and Terminates Exchange Offer

(CANF) FDA Grants Fast Track Designation for CF102

– Global market for liver cancer drugs is projected to exceed $2 billion in 2015

PETACH TIKVA, Israel, Sept. 17, 2015  — Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, today announced the U.S. Food and Drug Administration (FDA) has granted the Company’s drug candidate CF102 Fast Track designation as a second line treatment for hepatocellular carcinoma (HCC), the most common form of liver cancer. CF102 had already received the FDA’s Orphan Drug designation.

Can-Fite is currently conducting a Phase II study for this indication in the U.S., Europe and Israel. The randomized, double blind, placebo controlled study is expected to complete enrollment by the end of the first half of 2016 in 78 patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, Nexavar® (sorafenib). Patients are treated twice daily with 25 mg of oral CF102, which has been found to be the most efficacious dose in Can-Fite’s earlier Phase I/II study resulting in the longest overall survival time, with excellent safety results.

Fast Track, aimed at getting important new drugs that meet an unmet need to patients earlier, is expected to expedite the development of CF102. Drugs that receive Fast Track designation benefit from more frequent meetings and communications with the FDA to review the drug’s development plan to support approval. It also allows the Company to submit parts of the New Drug Application (NDA) on a rolling basis for review as data becomes available. Since the Fast Track Program started, from March 1998 through June 30, 2015 a total of 318 Fast Track applications have been received by the FDA. The FDA has granted 202 of them, and denied 110, with 6 more pending.

“We are very pleased that the FDA recognizes the potential for CF102 to treat HCC patients who have tried, and not been responsive to Nexavar, the only FDA approved drug currently on the market for this indication,” stated Can-Fite CEO Dr. Pnina Fishman. “We consider Fast Track designation to be a major catalyst for our CF102 development program and we believe it could shorten our time to market for CF102, thereby making a considerable difference for patients.”

According to Global Industry Analysts, the global market for liver cancer drugs is projected to exceed $2 billion in 2015. Nexavar® annual sales, as reported by Bayer, were €773 million in 2014.

About CF102 

CF102 is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in tumor cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. In Can-Fite’s pre-clinical and clinical studies, CF102 has demonstrated a robust anti-tumor effect via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company is preparing for a Phase III CF101 trial for rheumatoid arthritis and is preparing its protocol for its next advanced psoriasis clinical trial. Can-Fite’s liver cancer drug CF102 is in Phase II trials and has been granted Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration. CF102 has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. The Company’s CF602 has shown efficacy in the treatment of erectile dysfunction. Can-Fite has initiated a full pre-clinical program for CF602 in preparation for filing an IND with the U.S. FDA in this indication. These drugs have an excellent safety profile with experience in over 1,200 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Forward-Looking Statements

This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, Can-Fite or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by Can-Fite with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of Can-Fite’s authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause Can-Fite’s actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Can-Fite’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements, including, but not limited to, the factors summarized in Can-Fite’s filings with the SEC and in its periodic filings with the TASE. In addition, Can-Fite operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control. Can-Fite does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.

Contact

Can-Fite BioPharma

Motti Farbstein

info@canfite.com

+972-3-9241114

(CBLI) Publication of Efficacy Studies on Entolimod as a Radiation Countermeasure

(DHXM) new and classic Teletubbies heading to Italy with Rai

Rai YoYo licenses both incarnations of preschool phenomenon

HALIFAX, July 14, 2015  – DHX Media (“DHX” or the “Company”) (NASDAQ: DHXM; TSX: DHX.A, DHX.B), a key player internationally in the creation of content for families and children, has licensed its new and classic Teletubbies series to Italian broadcaster Rai.

The deal sees Rai’s preschool-skewing channel, Rai YoYo, acquiring rights to air DHX’s brand new 60 x 12′ Teletubbies series, which is currently in production and set to debut on the UK’s CBeebies later this year, as well as seasons 1 – 14 of the classic Teletubbies show.

Josh Scherba, SVP Distribution of DHX Media, said: “This deal with Rai and recent sales in the US and France underscore the considerable appetite globally for Teletubbies. That broadcasters are keen to snap up both the new and classic series highlights that this is a property with enduring appeal, poised to win a new generation of fans.”

The timeless, unique and much loved Teletubbies are re-imagined for a new generation with 60 brand new episodes for 2015, starring Tinky Winky, Dipsy, Laa-Laa and Po. With rewarding rituals, sound play, and physical comedy, new generation Teletubbies will build upon many familiar and beloved features of the original series, while offering some exciting and surprising new developments too. With the Teletubby landscape replaced and replicated by a beautiful, detailed model that will be enhanced via CGI, there will be freedom to apply large doses of creative imagination to Teletubby stories. The wonderful new world of the Teletubbies will resonate with preschoolers, reflecting child development and learning in a stimulating and contemporaneous manner.

Worldwide phenomenon Teletubbies first launched in March 1997 and became one of the most successful global children’s brands of all time. It has reached more than one billion children to date and the original episodes have aired in more than 120 territories in 45 different languages. It was the very first western pre-school property to air on China’s CCTV reaching an audience of 300 million children.

About Teletubbies
Originally created in 1997 Teletubbies is a children’s television series targeted at preschool viewers. In September 2013, DHX Media acquired all rights to Teletubbies through its purchase of Ragdoll Worldwide, a joint venture between Ragdoll Productions and BBC Worldwide that owned, managed and exploited Ragdoll programming.

Multi award-winning, Teletubbies is designed to encourage young children to watch television creatively. Full of fun and exploration it inspires confidence and curiosity and nurtures childhood development. DHX Media has engaged award-winning UK production company Darrall Macqueen to produce Teletubbies. Together they are pioneering a 21st century version of the show for a new generation of viewers.

About DHX Media
DHX Media Ltd. (www.dhxmedia.com), a key player internationally in the creation of content for families and children, is recognized globally for such brands as Yo Gabba Gabba!, Caillou, Teletubbies, In the Night Garden, Inspector Gadget, Johnny Test, Slugterra and the multiple award-winning Degrassi franchise. The Company is owner of the Family suite of channels, operated as DHX Television. DHX Media Ltd. markets and distributes its library of more than 11,000 half-hours of entertainment programming worldwide, and licenses its owned properties through its dedicated brand-management and consumer-products business, DHX Brands. DHX Media Ltd.’s full-service international licensing agency, Copyright Promotions Licensing Group Ltd. (CPLG), represents numerous entertainment, sport and design brands. With offices in 15 cities worldwide, including Toronto, Vancouver, Halifax, Los Angeles, London, Paris, Barcelona, Milan, Munich, Amsterdam and Beijing, DHX Media Ltd. is listed on the NASDAQ Global Select Market under the ticker symbol DHXM, and on the Toronto Stock Exchange under the ticker symbols DHX.A and DHX.B.

Disclaimer
This press release contains forward looking statements with respect to DHX including the completion of the production of the series, the timing of the television debut and the ability of the Company to place the series in other territories. Although the Company believes that the expectations reflected in such forward looking statements are reasonable, such statements involve risks and uncertainties and are based on information currently available to the Company. Actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations, among other things, include risk factors discussed in materials filed with applicable securities regulatory authorities from time to time including matters discussed under “Risk Factors” in the Company’s Annual Information Form for the year ended June 30, 2014, and annual Management Discussion and Analysis, which form part of the Company’s registration statement on Form 40-F filed with the United States Securities and Exchange Commission. These forward-looking statements are made as of the date hereof, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law.

(XNCR) & (AMGN) Strategic Collaboration In Cancer Immunotherapy And Inflammation

Combines Amgen’s Proprietary Antibodies and Xencor’s XmAb® Bispecific Antibody Platform to Develop New Therapeutic Candidates Includes Xencor’s Preclinical CD38 Bispecific T Cell Engager for Multiple Myeloma Xencor to Receive $45 Million Upfront Payment and Up to $1.7 Billion in Clinical, Regulatory and Sales Milestone Payments in Total for Six Programs

THOUSAND OAKS, Calif. and MONROVIA, Calif., Sept. 16, 2015  — Amgen (NASDAQ:AMGN) and Xencor, Inc. (Xencor) (NASDAQ:XNCR) announced today that the two companies have entered into a research and license agreement to develop and commercialize novel therapeutics in the areas of cancer immunotherapy and inflammation. The research collaboration brings together Amgen’s capabilities in target discovery and protein therapeutics with Xencor’s XmAb^® bispecific technology platform.

The collaboration includes molecular engineering by Xencor and the preclinical development of bispecific molecules for five programs proposed by Amgen, leveraging XmAb bispecific Fc domains to make half-life extended T cell engagers and dual targeting bispecific antibodies. The agreement also includes a preclinical bispecific T cell engager program directed at CD38 and CD3 for multiple myeloma.

Amgen will be fully responsible for preclinical and clinical development and commercialization worldwide. Under the terms of the agreement, Xencor will receive a $45 million upfront payment and up to $1.7 billion in clinical, regulatory and sales milestone payments in total for the six programs. Xencor is eligible to receive mid to high single-digit royalties for candidates directed against Amgen’s targets, and high single to low double-digit royalties for Xencor’s CD38 bispecific T cell engager.

“We are pleased to be joining forces with Xencor to expand our immuno-oncology and inflammation position by leveraging Amgen’s antibodies and Xencor’s bispecific antibody platform,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We are especially excited about the T cell engaging bispecific antibody directed against CD38, which complements Amgen’s BiTE^® platform, while growing our hematology and oncology portfolio that includes two bispecific T cell engager antibodies, BLINCYTO^® (blinatumomab) and AMG 330, as well as Kyprolis^® (carfilzomib) for relapsed multiple myeloma.”

Bispecific technologies seek to engineer monoclonal antibodies to bind two unique drug targets, as opposed to traditional antibodies designed to bind to a single antigen target. This approach represents a powerful opportunity in immuno-oncology to simultaneously engage immune cells and tumor cells to localize anti-tumor immune activity where it is needed most.

“Amgen, which has pioneered the use of bispecific antibodies, has chosen to access our XmAb bispecific technology for its robustness, long half-life, and the plug and play ease-of-development of our platform,” said Bassil Dahiyat, Ph.D., president and chief executive officer of Xencor. “This opportunity expands the reach of our technology with a partner that has proven experience in bispecifics and immuno-oncology. Xencor will continue to focus on its internal programs including its immuno-oncology XmAb bispecifics, XmAb14045 in acute myeloid leukemia and XmAb13676 in B-cell malignancies, which are expected to enter clinical development in 2016.”

About Xencor’s XmAb^® Bispecific Technology
As opposed to traditional monoclonal antibodies that target and bind to a single antigen, bispecific antibodies are designed to elicit multiple biological effects that require simultaneous binding to two different antigen targets. Xencor’s XmAb bispecific Fc domain technology is designed to maintain full-length antibody properties in a bispecific antibody, potentially enabling favorable in vivo half-life and simplified manufacturing.

Efforts at bispecific antibody design are typically frustrated by poor molecular stability, difficulties in production and short in vivo half-life. Xencor has engineered a series of Fc domain variants that spontaneously form stable, heterodimeric bispecific antibodies and that can be made and purified with standard antibody production methods. These bispecific Fc domains are used to generate a broad array of novel drug candidates in a range of molecule formats.

Xencor’s initial bispecific programs are tumor-targeted antibodies that contain both a tumor antigen binding domain and a cytotoxic T-cell binding domain (CD3 binding domain). These bispecific antibodies activate T cells at the site of the tumor for highly potent killing of malignant cells. The XmAb Fc domain format allows Xencor to tune the potency of the T-cell killing, potentially improving the tolerability of tumor immunotherapy. Xencor plans to begin clinical testing for two internal programs, XmAb14045 and XmAb13676, in 2016.

About Xencor Inc.
Xencor is a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of asthma and allergic diseases, autoimmune diseases and cancer. Currently, eight candidates that have been engineered with Xencor’s XmAb^® technology are in clinical development internally and with partners. Xencor’s internally-discovered programs include: XmAb5871, which completed a Phase 1b/2a clinical trial for the treatment of rheumatoid arthritis and is in preparation for a clinical trial in IgG4-related disease in 2015; XmAb7195 in Phase 1a development for the treatment of asthma; and XmAb5574/MOR208 which has been licensed to Morphosys AG and is in Phase 2 clinical trials for the treatment of acute lymphoblastic leukemia and non-Hodgkin’s lymphoma. Xencor’s XmAb antibody engineering technology enables small changes to the structure of monoclonal antibodies resulting in new mechanisms of therapeutic action. Xencor partners include Merck, Janssen R&D LLC, Alexion, Novo Nordisk and Boehringer Ingelheim. For more information, please visit www.xencor.com.

About Amgen’s Immuno-Oncology Focused Partnerships
Amgen’s recent immuno-oncology focused partnerships include:

• A collaboration with Merck on developing talimogene laherparepvec and KEYTRUDA^® (pembrolizumab) in melanoma and small cell cancer of the head and neck.
• A strategic research collaboration and license agreement to develop and commercialize the next generation of novel Chimeric Antigen Receptor (CAR) T cell immunotherapies with Kite Pharma.
• A research collaborative agreement focusing on Amgen’s bispecific T cell engager (BiTE^®) antibody constructs with MD Anderson’s Moon Shots Program.
• A collaboration with Roche on a cancer immunotherapy study with investigational medicines talimogene laherparepvec and atezolizumab.

About Kyprolis^® (carfilzomib) for Injection
Kyprolis^® (carfilzomib) for Injection is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy.

Kyprolis is also indicated under FDA accelerated approval as a single agent for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.

Kyprolis is a product of Onyx Pharmaceuticals, Inc. Onyx Pharmaceuticals is a subsidiary of Amgen and holds development and commercialization rights to Kyprolis globally, excluding Japan. Kyprolis is also approved for use in Argentina, Israel, Mexico and Thailand. For more information about Kyprolis, visit www.kyprolis.com

Important Safety Information Regarding Kyprolis^® (carfilzomib) for Injection

WARNINGS AND PRECAUTIONS
Cardiac Toxicities:
New onset or worsening of pre-existing cardiac failure (e.g., congestive heart failure, pulmonary edema, decreased ejection fraction), restrictive cardiomyopathy, myocardial ischemia, and myocardial infarction including fatalities have occurred following administration of Kyprolis. In clinical studies with Kyprolis, these events typically occurred early in the course of Kyprolis therapy (< 5 cycles). Death due to cardiac arrest has occurred within a day of Kyprolis administration. Withhold Kyprolis for Grade 3 or 4 cardiac adverse events until recovery, and consider whether to restart Kyprolis at 1 dose level reduction based on a benefit/risk assessment. While adequate hydration is required prior to each dose in Cycle 1, all patients should also be monitored for evidence of volume overload, especially patients at risk for cardiac failure. Adjust total fluid intake as clinically appropriate in patients with baseline cardiac failure or who are at risk for cardiac failure. In patients ≥ 75 years of age, the risk of cardiac failure is increased. Patients with New York Heart Association Class III and IV heart failure, recent myocardial infarction, and conduction abnormalities uncontrolled by medications were not eligible for the clinical trials. These patients may be at greater risk for cardiac complications.

Acute Renal Failure:
Cases of acute renal failure have occurred in patients receiving Kyprolis. Renal insufficiency adverse events (renal impairment, acute renal failure, renal failure) have occurred with an incidence of approximately 8% in a randomized controlled trial. Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received Kyprolis monotherapy. This risk was greater in patients with a baseline reduced estimated creatinine clearance (calculated using Cockcroft and Gault equation). Monitor renal function with regular measurement of the serum creatinine and/or estimated creatinine clearance. Reduce or withhold dose as appropriate.

Tumor Lysis Syndrome:
Cases of tumor lysis syndrome (TLS), including fatal outcomes, have been reported in patients who received Kyprolis. Patients with multiple myeloma and a high tumor burden should be considered to be at greater risk for TLS. Ensure that patients are well hydrated before administration of Kyprolis in Cycle 1, and in subsequent cycles as needed. Consider uric acid lowering drugs in patients at risk for TLS. Monitor for evidence of TLS during treatment and manage promptly including interruption of Kyprolis until TLS is resolved.

Pulmonary Toxicity:
Acute Respiratory Distress Sndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred in less than 1% of patients receiving Kyprolis. Some events have been fatal. In the event of drug-induced pulmonary toxicity, discontinue Kyprolis.

Pulmonary Hypertension:
Pulmonary arterial hypertension (PAH) was reported in approximately 1% of patients treated with Kyprolis and was Grade 3 or greater in less than 1% of patients. Evaluate with cardiac imaging and/or other tests as indicated. Withhold Kyprolis for pulmonary 11 hypertension until resolved or returned to baseline and consider whether to restart Kyprolis based on a benefit/risk assessment.

Dyspnea:
Dyspnea was reported in 28% of patients treated with Kyprolis and was Grade 3 or greater in 4 % of patients. Evaluate dyspnea to exclude cardiopulmonary conditions including cardiac failure and pulmonary syndromes. Stop Kyprolis for Grade 3 or 4 dyspnea until resolved or returned to baseline. Consider whether to restart Kyprolis based on a benefit/risk assessment.

Hypertension:
Hypertension, including hypertensive crisis and hypertensive emergency, has been observed with Kyprolis. Some of these events have been fatal. Monitor blood pressure regularly in all patients. If hypertension cannot be adequately controlled, withhold Kyprolis and evaluate. Consider whether to restart Kyprolis based on a benefit/risk assessment.

Venous Thrombosis:
Venous thromboembolic events (including deep venous thrombosis and pulmonary embolism) have been observed with Kyprolis. In the combination study, the incidence of venous thromboembolic events in the first 12 cycles was 13% in the Kyprolis combination arm versus 6% in the control arm. With Kyprolis monotherapy, the incidence of venous thromboembolic events was 2%. Thromboprophylaxis is recommended and should be based on an assessment of the patient’s underlying risks, treatment regimen, and clinical status.

Infusion Reactions:
Infusion reactions, including life-threatening reactions, have occurred in patients receiving Kyprolis. Symptoms include fever, chills, arthralgia, myalgia, facial flushing, facial edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. These reactions can occur immediately following or up to 24 hours after administration of Kyprolis. Administer dexamethasone prior to Kyprolis to reduce the incidence and severity 12 of infusion reactions. Inform patients of the risk and of symptoms and to contact a physician immediately if symptoms of an infusion reaction occur.

Thrombocytopenia:
Kyprolis causes thrombocytopenia with platelet nadirs observed between Day 8 and Day 15 of each 28-day cycle with recovery to baseline platelet count usually by the start of the next cycle. Thrombocytopenia was reported in approximately 40% of patients in clinical trials with Kyprolis. Monitor platelet counts frequently during treatment with Kyprolis. Reduce or withhold dose as appropriate.

Hepatic Toxicity and Hepatic Failure:
Cases of hepatic failure, including fatal cases, have been reported (< 1%) during treatment with Kyprolis. Kyprolis can cause increased serum transaminases. Monitor liver enzymes regularly. Reduce or withhold dose as appropriate.

Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome:
Cases of thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS) including fatal outcome have been reported in patients who received Kyprolis. Monitor for signs and symptoms of TTP/HUS. If the diagnosis is suspected, stop Kyprolis and evaluate. If the diagnosis of TTP/HUS is excluded, Kyprolis may be restarted. The safety of reinitiating Kyprolis therapy in patients previously experiencing TTP/HUS is not known.

Posterior Reversible Encephalopathy Syndrome (PRES):
Cases of PRES have been reported in patients receiving Kyprolis. Posterior reversible encephalopathy syndrome (PRES), formerly termed Reversible Posterior Leukoencephalopathy Syndrome (RPLS), is a neurological disorder which can present with seizure, headache, lethargy, confusion, blindness, altered consciousness, and other visual and neurological disturbances, along with hypertension, and the diagnosis is confirmed by neuro-radiological imaging (MRI). Discontinue Kyprolis if PRES is suspected and evaluate.  The safety of reinitiating Kyprolis therapy in patients previously experiencing PRES is not known.

Embryo-fetal Toxicity:
Kyprolis can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. There are no adequate and well-controlled studies in pregnant women using Kyprolis. Kyprolis caused embryo-fetal toxicity in pregnant rabbits at doses that were lower than in patients receiving the recommended dose. Females of reproductive potential should be advised to avoid becoming pregnant while being treated with Kyprolis. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

ADVERSE REACTIONS
The most common adverse events occurring in at least 20% of patients treated with Kyprolis in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, decreased platelets, dyspnea, diarrhea, decreased lymphocyte, headache, decreased hemoglobin, cough, edema peripheral.

The most common adverse events occurring in at least 20% of patients treated with Kyprolis in the combination therapy trial: decreased lymphocytes, decreased absolute neutrophil count, decreased phosphorus, anemia, neutropenia, decreased total white blood cell count, decreased platelets, diarrhea, fatigue, thrombocytopenia, pyrexia, muscle spasm, cough, upper respiratory tract infection, decreased hemoglobin, hypokalemia.

USE IN SPECIFIC POPULATIONS
Patients on dialysis: Administer Kyprolis after the dialysis procedure.

POST-MARKETING EXPERIENCE
The following adverse reactions were reported in the post-marketing experience: dehydration, thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), tumor lysis syndrome including fatal outcomes, and posterior reversible encephalopathy syndrome (PRES). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Full prescribing information is available at www.kyprolis.com.

About BLINCYTO^® (blinatumomab)
BLINCYTO^® (blinatumomab) is the first bispecific CD19-directed CD3 T cell engager (BiTE^®) antibody construct product, and the first single-agent immunotherapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), a rare and rapidly progressing cancer of the blood and bone marrow.^1,2  Prior to approval, BLINCYTO was granted breakthrough therapy and priority review designations by the FDA. BLINCYTO has a BOXED WARNING in its product label regarding Cytokine Release Syndrome (CRS) and Neurological Toxicities. (Please see Important Safety Information below).

About BiTE^® Technology
Bispecific T cell engager (BiTE^®) antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body’s immune system to detect and target malignant cells. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. BiTE^® antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE^® antibody constructs are currently being investigated for their potential to treat a wide variety of cancers. For more information, visit www.biteantibodies.com.

Important U.S. Product Information
BLINCYTO^® is indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES

• Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO^®. Interrupt or discontinue BLINCYTO^® as recommended.
• Neurological toxicities, which may be severe, life-threatening or fatal, occurred in patients receiving BLINCYTO^®. Interrupt or discontinue BLINCYTO^® as recommended.

Contraindications
BLINCYTO^® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.

Warnings and Precautions

• Cytokine Release Syndrome (CRS): Life-threatening or fatal CRS occurred in patients receiving BLINCYTO^®. Infusion reactions have occurred and may be clinically indistinguishable from manifestations of CRS. Closely monitor patients for signs and symptoms of serious events such as pyrexia, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased total bilirubin (TBILI), disseminated intravascular coagulation (DIC), capillary leak syndrome (CLS), and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Interrupt or discontinue BLINCYTO^® as outlined in the Prescribing Information (PI).
• Neurological Toxicities: Approximately 50% of patients receiving BLINCYTO^® in clinical trials experienced neurological toxicities. Severe, life-threatening, or fatal neurological toxicities occurred in approximately 15% of patients, including encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders. The median time to onset of any neurological toxicity was 7 days. Monitor patients for signs or symptoms and interrupt or discontinue BLINCYTO^® as outlined in the PI.
• Infections: Approximately 25% of patients receiving BLINCYTO^® experienced serious infections, some of which were life-threatening or fatal. Administer prophylactic antibiotics and employ surveillance testing as appropriate during treatment. Monitor patients for signs or symptoms of infection and treat appropriately, including interruption or discontinuation of BLINCYTO^® as needed.
• Tumor Lysis Syndrome (TLS): Life-threatening or fatal TLS has been observed. Preventive measures, including pretreatment nontoxic cytoreduction and on treatment hydration, should be used during BLINCYTO^® treatment. Monitor patients for signs and symptoms of TLS and interrupt or discontinue BLINCYTO^® as needed to manage these events.
• Neutropenia and Febrile Neutropenia, including life-threatening cases, have been observed. Monitor appropriate laboratory parameters during BLINCYTO^® infusion and interrupt BLINCYTO^® if prolonged neutropenia occurs.
• Effects on Ability to Drive and Use Machines: Due to the possibility of neurological events, including seizures, patients receiving BLINCYTO^® are at risk for loss of consciousness, and should be advised against driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO^® is being administered.
• Elevated Liver Enzymes: Transient elevations in liver enzymes are associated with BLINCYTO^® treatment. The majority of these events were observed in the setting of CRS. The median time to onset was 15 days. Grade 3 or greater elevations in liver enzymes occurred in 6% of patients outside the setting of CRS and resulted in treatment discontinuation in less than 1% of patients. Monitor ALT, AST, gamma-glutamyl transferase (GGT), and TBILI prior to the start of and during BLINCYTO^® treatment. BLINCYTO^® treatment should be interrupted if transaminases rise to > 5 times the upper limit of normal (ULN) or if TBILI rises to > 3 times ULN.
• Leukoencephalopathy: Although the clinical significance is unknown, cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO^®, especially in patients previously treated with cranial irradiation and anti-leukemic chemotherapy.
• Preparation and administration errors have occurred. Follow instructions for preparation (including admixing) and administration in the PI strictly to minimize medication errors (including underdose and overdose).

Adverse Events

• The most commonly reported adverse reactions (≥ 20%) in clinical trials were pyrexia (62%), headache (36%), peripheral edema (26%), febrile neutropenia (26%), nausea (25%), hypokalemia (23%), rash (21%), tremor (20%) and constipation (20%).
• Serious adverse reactions were reported in 65% of patients. The most common serious adverse reactions (≥ 2%) included febrile neutropenia, pyrexia, pneumonia, sepsis, neutropenia, device-related infection, tremor, encephalopathy, infection, overdose, confusion, Staphylococcal bacteremia, and headache.

Dosage and Administration Guidelines

• BLINCYTO^® is administered as a continuous intravenous infusion at a constant flow rate using an infusion pump which should be programmable, lockable, non-elastomeric, and have an alarm.
• It is very important that the instructions for preparation (including admixing) and administration provided in the full Prescribing Information are strictly followed to minimize medication errors (including underdose and overdose).

Please see full Prescribing Information and medication guide for BLINCYTO^® at www.BLINCYTO.com.

About AMG 330
AMG 330 is a novel  CD33/CD3 BiTE^® antibody developed to recruit T cells to recognize and kill CD33 expressing acute myeloid leukemia (AML) target cells.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen) and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen Inc., including Amgen Inc.’s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen Inc.’s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to Amgen’s business. Unless otherwise noted, Amgen is providing this information as of Sept. 16, 2015, and expressly disclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen and its partners to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with Amgen’s products after they are on the market. Amgen’s business may be impacted by government investigations, litigation and product liability claims. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Amgen depends on third parties for a significant portion of its manufacturing capacity for the supply of certain of its current and future products and limits on supply may constrain sales of certain of its current products and product candidate development.

In addition, sales of Amgen’s products are affected by the reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others’ regulations and reimbursement policies may affect the development, usage and pricing of Amgen’s products. In addition, Amgen competes with other companies with respect to some of its marketed products as well as for the discovery and development of new products. Amgen believes that some of its newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen’s products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with its products. In addition, while Amgen and its partners routinely obtain patents for their products and technology, the protection of Amgen’s products offered by patents and patent applications may be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen’s or its partners’ ability to obtain or maintain patent protection for Amgen’s products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of its existing products. Amgen’s stock price may be affected by actual or perceived market opportunity, competitive position and success or failure of its products or product candidates. Further, the discovery of significant problems with a product similar to one of Amgen’s products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on Amgen’s business and results of operations. Amgen’s efforts to integrate the operations of companies it has acquired may not be successful. Amgen may experience difficulties, delays or unexpected costs and not achieve anticipated cost savings from its ongoing restructuring plan. Amgen’s business performance could affect or limit the ability of Amgen’s Board of Directors to declare a dividend or their ability to pay a dividend or repurchase Amgen common stock.

The scientific information discussed in this news release related to Amgen’s product candidates is preliminary and investigative.  Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

Xencor Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are forward-looking statements within the meaning of applicable securities laws, including the quotation from Xencor’s officers and any expectations relating to its business, research and development programs, including the XmAb bispecific antibody technology, partnering efforts or its capital requirements. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of  events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks described in Xencor’s public securities filings. All forward-looking statements are based on Xencor’s current information and belief as well as assumptions made by Xencor. Readers are cautioned not to place undue reliance on such statements and Xencor disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (media)
Kristen Neese, 805-313-8267 (media)
Arvind Sood, 805-447-1060 (investors)

CONTACT: Xencor, Monrovia
John Kuch, 626-737-8013 (investors)
Jason I. Spark, 619-849-6005 Canale Communications for Xencor (media)

(AERI) Reports Positive Rhopressa™ Phase 3 Efficacy Results

Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies, today reported the successful results of its second Phase 3 trial for Rhopressa^™, a novel once-daily, triple-action eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. The trial achieved its primary efficacy endpoint demonstrating non-inferiority of Rhopressa^™ compared to timolol, the most widely used comparator. Management will host a conference call and provide accompanying slides to discuss these results at 5:00 p.m. ET today.

Rhopressa^™ Phase 3 Highlights for Rocket 2

• Rhopressa^™, dosed both once-daily and twice-daily, achieved its primary efficacy endpoint demonstrating non-inferiority compared to twice-daily timolol. The primary efficacy endpoint evaluated subjects with pre-study baseline IOPs of above 20 to below 25 mmHg (millimeters of mercury).
• The Rocket 2 efficacy results for Rhopressa^™ demonstrated a consistent level of IOP lowering across all baseline IOPs and throughout the 90-day efficacy period.
• The most common Rhopressa^™ adverse event was hyperemia, or eye redness, which was reported as increased in 35 percent of patients and was scored as mild for 83 percent of patients in the Rhopressa^™ once-daily arm of the trial. The adverse event profile for the Rhopressa^™ once-daily arm was consistent with the results of Rocket 1.
• With these successful Rocket 2 results, and the successful performance of Rhopressa^™ in Rocket 1 at baseline IOPs below 25 mmHg, Aerie expects to file its NDA for Rhopressa^™ in mid-2016.

As expected, Rhopressa^™ dosed twice-daily generated a higher incidence of adverse events and was slightly more efficacious than Rhopressa^™ dosed once-daily.

“We are very impressed by these Rhopressa^™ Phase 3 results from the Rocket 2 study. This product has demonstrated great promise with its novel mechanisms of action, including its ability to target the diseased tissue responsible for elevated IOP in glaucoma. The clear success demonstrated in this clinical trial, combined with the preclinical research to date on the disease-modification potential of Rhopressa^™, represent key building blocks in driving Aerie toward becoming a major ophthalmic pharmaceutical company,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.

Dr. Anido continued, “We look forward to our Rocket 2 safety results expected at the end of 2015 or early 2016. Based on our previous discussions with the FDA, we expect to file our Rhopressa^™ NDA in mid-2016.”

Richard A. Lewis, M.D., Aerie’s newly appointed Chief Medical Officer who is a glaucoma specialist in Sacramento, California, past President of the American Society of Cataract and Refractive Surgeons (ASCRS) and past President of the American Glaucoma Society (AGS), added, “Clinicians have been waiting for an IOP-lowering product that targets the diseased tissue. None of the treatments currently in the market have this unique function. The Rhopressa^™ efficacy data we see in these Rocket 2 results point to a potential breakthrough for our glaucoma patients.”

Triple-Action Rhopressa^™

Rhopressa^™ is a novel triple-action eye drop that we believe, if approved, would become the only once-daily product available that specifically targets the trabecular meshwork, the eye’s primary fluid drain and the diseased tissue responsible for elevated IOP in glaucoma. Preclinical results have demonstrated that Rhopressa^™ also lowers episcleral venous pressure, which contributes approximately half of IOP in healthy subjects. Further, Rhopressa^™ provides an additional mechanism that reduces fluid production in the eye and therefore lowers IOP. Biochemically, Rhopressa^™ is known to inhibit both Rho Kinase (ROCK) and norepinephrine transporter (NET). Recent preclinical studies have shown that Rhopressa^™ may have disease-modifying properties, including an anti-fibrotic effect on the trabecular meshwork and the potential to increase perfusion of the trabecular meshwork. Preclinical research is also currently underway to evaluate the potential neuroprotective benefits of Rhopressa^™.

There are four Phase 3 registration trials for Rhopressa^™. “Rocket 2,” the efficacy results of which are reported in this press release, is a 12-month safety trial with a 90-day interim efficacy readout. Safety data for the 12-month period of the Rocket 2 trial is expected late 2015 or early 2016. “Rocket 1,” the results of which were initially reported in April 2015, was a 90-day efficacy trial that did not achieve its primary endpoint, but did achieve its pre-specified secondary endpoint. “Rocket 3” is a 12-month safety-only study in Canada which is currently in progress. A fourth Phase 3 trial, named “Rocket 4,” is expected to commence in late September 2015. Based on the successful results of Rocket 2, Aerie expects to submit a New Drug Application filing for Rhopressa^™ in mid-2016.

Conference Call / Web Cast Information

Aerie management will host a live conference call and webcast at 5:00 p.m. Eastern Time today to discuss the Rhopressa^™ Phase 3 efficacy results from Rocket 2.

The live webcast and a replay may be accessed by visiting Aerie’s website at http://investors.aeriepharma.com. In addition, key data slides from the Rhopressa^™ Rocket 2 study will be discussed on the conference call and are posted to the website. Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call 1-888-734-0328 (U.S.) or 1-678-894-3054 (international) to listen to the live conference call. The conference ID number for the live call is 42505859. Please dial in approximately 10 minutes prior to the call. Telephone replay will be available approximately two hours after the call. To access the replay, please call 1-855-859-2056 (U.S.) or 1-404-537-3406 (international). The conference ID number for the replay is 42505859. The telephone replay will be available until September 22, 2015.

About Aerie Pharmaceuticals, Inc.

Aerie is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye. Aerie reported today the successful results of the Phase 3 registration trial in the United States named Rocket 2, where the primary efficacy endpoint was to demonstrate non-inferiority of IOP lowering for Rhopressa^™ compared to timolol. Aerie recently completed its first Phase 3 registration trial, named Rocket 1, the three-month efficacy results of which were initially reported in April 2015, and expects to commence a fourth Phase 3 registration trial, named Rocket 4, in late September 2015. Aerie also completed in 2014 a Phase 2b clinical trial in which Roclatan^™ met the primary efficacy endpoint, demonstrating the statistical superiority of Roclatan^™ to each of its components, and plans to commence the first Phase 3 registration trial for Roclatan^™, named Mercury 1, in late September 2015. Aerie also recently announced research collaborations with GrayBug, Inc. and Ramot at Tel Aviv University as it further builds it pipeline for future growth.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “exploring,” “pursuing” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the success, timing and cost of our ongoing and anticipated preclinical studies and clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of the studies and trials; our expectations regarding the clinical effectiveness of our product candidates and results of our clinical trials; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates; our expectations regarding the commercialization of our product candidates; our expectations related to the use of proceeds from our initial public offering and the issuance and sale of our senior secured convertible notes; our estimates regarding anticipated capital requirements and our needs for additional financing; the potential advantages of our product candidates; our plans to pursue development of our product candidates for additional indications and other therapeutic opportunities; our plans to explore possible uses of our existing proprietary compounds beyond glaucoma; and our ability to protect our proprietary technology and enforce our intellectual property rights. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change, and depend on regulatory approvals and economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. We discuss many of these risks in greater detail under the heading “Risk Factors” in the quarterly and annual reports that we file with the Securities and Exchange Commission (SEC). In particular, the preclinical research discussed in this press release is preliminary and the outcome of such preclinical studies may not be predictive of the outcome of later clinical trials. Any future clinical trial results may not demonstrate safety and efficacy sufficient to obtain regulatory approval related to the preclinical research findings discussed in this press release. Forward-looking statements are not guarantees of future performance and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Aerie Pharmaceuticals
Richard Rubino, 908-947-3540
rrubino@aeriepharma.com
or
Burns McClellan, Inc., on behalf of Aerie Pharmaceuticals
Investors
Ami Bavishi, 212-213-0006
abavishi@burnsmc.com
or
Media
Justin Jackson, 212-213-0006
jjackson@burnsmc.com

(ADEP) OMRON to Acquire U.S. Based Adept Technology

OMRON Corporation (President & CEO: Yoshihito Yamada [TOKYO:6645]) (“OMRON”), a global leader in the field of automation based on its core sensing and control technology, and Adept Technology, Inc. (President and Chief Executive Officer: Rob Cain [NASDAQ:ADEP]) (“Adept”), a global, leading provider of intelligent robots, autonomous mobile robot solutions and services, today announced that the two companies have entered into an agreement whereby OMRON will acquire Adept.

OMRON plans to acquire 100% of the outstanding shares of Adept common stock through an all cash tender offer followed by a second-step merger. OMRON will offer Adept investors $13.00 per share of Adept common stock, which represents a 63% premium over the closing price for Adept’s common stock on September 15, 2015. This values Adept at approximately $200 million. OMRON will fund the tender offer through cash on hand.

The tender offer is expected to commence on or about September 23, 2015, and the transaction is expected to close on or about October 22, 2015. The closing of the transaction is subject to customary closing conditions, including at least a majority of shares of Adept common stock being tendered in the offer, expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and receipt of required foreign antitrust approvals. The transaction has been unanimously approved by the Boards of Directors of both companies.

Commenting on the acquisition, Yutaka Miyanaga, OMRON Industrial Automation Business Company President, said, “We are delighted Adept Technology, a world leader in robotics, has agreed to join OMRON. This acquisition is part of our strategy to enhance our automation technology and position us for long term growth. Robotics will elevate our offering of advanced automation.”

Rob Cain, President and Chief Executive Officer of Adept, added, “We are excited about the opportunity to join OMRON, a global leader in automation. Together, our products will offer new innovative solutions to customers all around the globe.”

Following the transaction, Rob Cain will continue to lead Adept and will report to Nigel Blakeway, Chairman, Chief Executive Officer and President of Omron Management Center of America, Inc., OMRON’s wholly owned United States subsidiary.

As global manufacturing comes under even more pressure to cut costs, shorten supply cycles and operate across global environments, production sites around the world strive to improve productivity. Increased use of labor-saving robots is one of the solutions. By adding the robotics technology of Adept to its current offering, OMRON will be very well positioned to provide manufacturers in the automotive, digital device, food and beverage, packaging, and other industries with solutions to these challenges, as well as engineering support.

Founded in 1983, Adept is listed on NASDAQ under the ticker symbol ADEP. The company recorded annual sales of $54.2 million and gross margin of 42.0% in the fiscal year ended June 30, 2015.

Adept is a leading U.S. based manufacturer of industrial robots. Adept’s intelligent automation product lines include autonomous mobile robots, industrial robots, configurable linear modules, machine controllers for robot mechanisms and other flexible automation equipment, as well as machine vision systems and software. Adept’s strategy is to provide a broad range of highly reliable integrated products along with world-class service to allow manufacturers to maximize productivity, safety, flexibility and product quality.

This acquisition is a part of the acceleration of OMRON’s “ILO+S” (Input, Logic, Output and Safety) strategy for its Industrial Automation Business, which provides automation solutions for the manufacturing industries.

OMRON currently has the most comprehensive automation product portfolio in the world that spans the spectrum of ILO+S for automation systems. By acquiring Adept, OMRON will further enhance this offering by adding R (robotics) and advancing its strategy to “ILO+S+R” to meet the needs of customers.

Robert W. Baird & Co. is acting as financial advisor to OMRON and Foley & Lardner LLP is acting as legal counsel. Mooreland Partners LLC is acting as financial advisor to Adept and Gibson, Dunn & Crutcher LLP is acting as legal counsel.

About Adept Technology

Adept is a global, leading provider of intelligent robots, autonomous mobile robot solutions, and services that enable customers to achieve precision, speed, quality and productivity in their assembly, handling, packaging, testing, and logistical processes. With a comprehensive portfolio of high-performance motion controllers, application development software, vision-guidance technology and high-reliability robot mechanisms with autonomous capabilities, Adept provides specialized, cost-effective robotics systems and services to high-growth markets including medical, electronics, food and semiconductor; as well as to traditional industrial markets including machine tool automation and automotive components. More information is available at www.adept.com

About OMRON Corporation

OMRON Corporation is a global leader in the field of automation based on its core technology of sensing and control. OMRON’s business fields cover a broad spectrum, ranging from industrial automation and electronic components to automotive electronic components, social infrastructure systems, healthcare, and environmental solutions. Established in 1933, OMRON has about 39,000 employees worldwide, working to provide products and services in more than 110 countries and regions.

In the field of industrial automation, OMRON supports manufacturing innovation by providing advanced automation technology and products, as well as through extensive customer support, in order to help create a better society. For more information, visit OMRON’s website: www.omron.com.

Forward-Looking Statements

Any statements made concerning the proposed transaction between Adept, Omron, Parent and Merger Sub, the expected timetable for completing the transaction, the successful integration of the business, the benefits of the transaction, future revenue and earnings and any other statements that are not purely historical fact are forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from the results expressed or implied by such statements, including general economic and business conditions, conditions affecting the industries served by Adept, Omron, Parent and their respective subsidiaries, conditions affecting Adept’s, Omron’s or Parent’s customers and suppliers, competitor responses to Adept’s, Omron’s or Parent’s products and services, the overall market acceptance of such products and services, the integration of the businesses and other factors disclosed in Adept’s periodic reports filed with the SEC. Consequently, such forward-looking statements should be regarded as Adept’s and Parent’s current plans, estimates and beliefs. Neither Adept nor Omron, Parent or Merger Sub assume any obligation to update the forward-looking information contained in this report, except as expressly required by law.

Additional Information and Where You Can Find It

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities. The tender offer for the outstanding shares of Adept’s common stock described in this communication has not commenced. At the time the tender offer is commenced, Omron will file or cause to be filed a Tender Offer Statement on Schedule TO with the Securities and Exchange Commission (“SEC”) and Adept will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC related to the tender offer. The Tender Offer Statement (including an Offer to Purchase, a related Letter of Transmittal and other tender offer documents) and the Solicitation/Recommendation Statement will contain important information that should be read carefully before any decision is made with respect to the tender offer. Those materials will be made available to Adept’s stockholders at no expense to them by the information agent to the tender offer, which will be announced. In addition, all of those materials (and any other documents filed with the SEC) will be available at no charge on the SEC’s website at www.sec.gov.

For media inquiries, please contact:
Omron Management Center of America, Inc.:
Edelman US, Brett Philbin
+1-212-704-8263
brett.philbin@edelman.com
or
OMRON Corporation:
Edelman Japan, Yoko Kato
+81-3-4360-9000
yoko.kato@edelman.com
or
Adept Technology, Inc.
Seth Halio, CFO, +1-925-245-3400
Investor.relations@adept.com

(ITCI) Top-Line Results First Phase 3 Trial of ITI-007 in Schizophrenia

ITI-007 60 mg once-daily met the primary and key secondary efficacy endpoints in the Phase 3 trial
ITI-007 60 mg significantly improved social functioning as measured by the Personal and Social Performance Scale
ITI-007 demonstrated a safety and tolerability profile that did not differ from placebo on key parameters of body weight, cardiovascular function and vital signs, glucose, lipids, prolactin, akathisia and other motoric disturbances

Intra-Cellular Therapies to Host a Conference Call Today at 8:30 a.m. ET to Discuss Results

NEW YORK, Sept. 15, 2015  — Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced positive results from the first Phase 3 clinical trial of ITI-007 for the treatment of patients with schizophrenia. In this trial, once-daily ITI-007 60 mg met the primary endpoint and demonstrated antipsychotic efficacy with statistically significant superiority over placebo at Week 4 (study endpoint) as measured by the change from baseline on the Positive and Negative Syndrome Scale (PANSS) total score (p=0.022). Moreover, ITI-007 60 mg showed significant antipsychotic efficacy as early as week 1, which was maintained at every time point throughout the entire study. ITI-007 60 mg also met the key secondary endpoint of statistically significant improvement on the Clinical Global Impression Scale for Severity of Illness (CGI-S; p=0.003). These findings confirm the positive results demonstrated by ITI-007 60 mg in the Company’s Phase 2 study. Consistent with previous studies, ITI-007 had a favorable safety and tolerability profile as evidenced by motoric, metabolic, and cardiovascular characteristics similar to placebo, and no clinically significant changes in akathisia, extrapyramidal symptoms, prolactin, body weight, glucose, insulin, or lipids.

The Company also announced top-line data from a separate clinical study using positron emission tomography (PET) in patients with schizophrenia. In this trial, ITI-007 60 mg was associated with a mean of approximately 40% striatal dopamine D₂ receptor occupancy. As predicted by preclinical and earlier clinical data, ITI-007 demonstrated antipsychotic effect at relatively low striatal D₂ receptor occupancy, lower than the occupancy range required by most other antipsychotic drugs. Unlike any existing schizophrenia treatment, this dopamine receptor phosphoprotein modulator, or DPPM, acts as a pre-synaptic partial agonist and post-synaptic antagonist at D₂ receptors. This mechanism likely contributes to the favorable safety profile of ITI-007, with reduced risk for hyperprolactinemia, akathisia, extrapyramidal symptoms, and other motoric side effects. The data from both clinical trials will be presented at upcoming scientific meetings.

“ITI-007 demonstrated efficacy in the treatment of patients with schizophrenia,” said Dr. Carol Tamminga, Professor and Chairman, Department of Psychiatry, University of Texas Southwestern Medical School, and the Lou and Ellen McGinley Distinguished Chair in Psychiatric Research. “To have achieved efficacy at lower dopamine receptor occupancy levels more commonly associated with clozapine, arguably the most efficacious antipsychotic, while maintaining a placebo-like safety and tolerability profile is a remarkable advance in the development of drugs for schizophrenia.”

“We are very encouraged by the positive results of our first Phase 3 trial. These data confirm the findings from our previous placebo- and risperidone active-controlled, randomized Phase 2 trial. The antipsychotic effect of 60 mg is confirmed and shows itself to be well-tolerated along with a safety profile similar to placebo,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “Patients deserve a treatment choice which gives them symptom relief without the associated movement disorders, metabolic disturbances or cardiovascular effects observed with many antipsychotics. We are excited about our progress towards delivering a novel treatment option for patients.”

About the Phase 3 ITI-007-301 Trial

This randomized, double-blind, fixed-dose, placebo-controlled Phase 3 clinical trial was conducted at 12 sites in the United States with 450 patients randomized (1:1:1) to receive either ITI-007 60 mg or 40 mg or placebo once daily in the morning for four weeks. Patients were diagnosed with schizophrenia (using DSM-5 criteria) and were required to have an acute exacerbation of psychotic symptoms. The pre-specified primary efficacy measure was change from baseline versus placebo at study endpoint (4 weeks) on the centrally rated PANSS total score. The key secondary endpoint was the centrally rated CGI-S. Trial participants had a mean PANSS score of 89.8 at baseline indicative of being markedly ill. Once daily morning dosing allowed for comprehensive safety assessments during the day throughout the study, including measurement of cardiovascular function, vital signs, body weight, and laboratory assessments. This is the first of two Phase 3 clinical trials intended to evaluate the efficacy, safety and tolerability of ITI-007 for the treatment of schizophrenia.

Primary and Key Secondary Efficacy Endpoints

ITI-007 60 mg met the primary efficacy endpoint by demonstrating a statistically significant improvement versus placebo on the PANSS total score, in the intent-to-treat (ITT) study population (least squares [LS] mean change from baseline -14.5 points, effect size [ES]=0.30, p=0.022 versus -10.3 points change from baseline for placebo). ITI-007 showed a dose-related improvement in symptoms of schizophrenia with the 40 mg dose approximating the trajectory of improvement seen with the 60 mg dose, but the effect with 40 mg did not reach statistical significance on the primary endpoint (-12.9 points, ES=0.18, p=0.164). The pre-specified primary statistical analysis used a Mixed-Effect Model Repeated Measure (MMRM) method for handling missing data in the ITT study population and was corrected for multiple comparisons.

ITI-007 60 mg met the key secondary endpoint demonstrating a statistically significant improvement versus placebo on the CGI-S, a well-established and clinically useful rating tool to determine a global level of illness severity (ES=0.39, p=0.003).  ITI-007 40 mg also demonstrated a statistically significant improvement versus placebo on the CGI-S (ES=0.30, p=0.025), though not formally tested against placebo since it did not separate on the primary endpoint.

Safety & Tolerability

Dosing in the morning, as in our earlier Phase 2 study, allowed for a comprehensive safety assessment throughout the study. ITI-007 was well-tolerated and demonstrated a safety profile that did not differ from placebo.  The majority of adverse events were mild in nature and the rates of discontinuation due to adverse events for either dose of ITI-007 were low and similar to placebo. Of particular clinical importance in schizophrenia, both doses of ITI-007 showed no significant difference from placebo on weight gain (mean change from baseline body weight over 4 weeks of treatment).  Furthermore, no significant differences were observed compared to placebo on metabolic parameters (including cholesterol, triglycerides, glucose and insulin) or on prolactin levels. Key measures of cardiovascular function (including heart rate, QTc intervals and other ECG parameters) were similar between ITI-007 and placebo.  These findings are consistent with previous studies and provide further evidence that ITI-007 is not associated with the usual side effects of existing medications for schizophrenia.

The most commonly reported adverse events that were considered at least possibly related to ITI-007 and that were observed at rates greater than 5% and at least twice the rate of placebo were limited to somnolence (predominantly mild with a frequency of 10.7% for 40 mg and 17.3% for 60 mg versus 4.0% for placebo), mild sedation (9.3% for 40 mg and 12.0% for 60 mg versus 5.4% for placebo), and fatigue (predominantly mild with a frequency of 4.0% for 40 mg and 5.3% for 60 mg versus 1.3% for placebo). Adverse events observed in the trial were generally mild with low, placebo-like discontinuation rates for ITI-007. Akathisia and other movement disturbances, did not differ significantly from placebo, as measured by adverse event reporting, the Simpson-Angus Scale, the Barnes Akathisia Rating Scale, or the Abnormal Involuntary Movement Scale. Importantly, there was no increase in suicidal ideation or suicidal behavior with ITI-007 over placebo.

Additional Efficacy Data

ITI-007 60 mg demonstrated early control over symptoms associated with schizophrenia as demonstrated by statistically significant improvement after only 1 week of treatment compared to placebo as measured by the PANSS total score and as measured by the PANSS Positive Symptom Subscale. The effect of ITI-007 60 mg was maintained with statistically significant separation from placebo at each weekly measurement of the PANSS total score and the PANSS Positive Symptom Subscale for the full duration of the study treatment period. ITI-007 40 mg demonstrated numerically better PANSS total and PANSS Positive Symptom Subscale scores compared to placebo at every visit, but the improvement with 40 mg did not reach statistical significance at study endpoint. Furthermore, both doses of ITI-007 improved the PANSS Negative Symptom Subscale score more than placebo in the ITT population, but the improvement did not reach statistical significance in this 4 week study.  These and additional data will be presented at upcoming scientific meetings.

ITI-007 60 mg demonstrated improved social functioning as measured by the Personal and Social Performance Scale (PSP) with a statistically significant improvement compared to placebo. The PSP scale is a validated scale that measures a person’s level of psychosocial functioning across four important social domains: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. ITI-007 40 mg showed a numerical improvement in PSP compared to placebo, but did not reach statistical significance.

About the ITI-007-008 Positron Emission Tomography (PET) Study

This open-label study was conducted in patients diagnosed with schizophrenia who were otherwise healthy and stable with respect to their psychosis. After washout from their previous antipsychotic medication for at least two weeks, PET was used to determine target occupancy in brain regions at baseline (drug-free) and again after two weeks of once daily ITI-007 oral administration. [¹¹C]-Raclopride was used as the radiopharmaceutical for imaging striatal dopamine D₂ receptors in patients receiving 60 mg ITI-007 (N=10). Other radiopharmaceuticals for imaging other targets and other doses of ITI-007 were included as exploratory endpoints; exploratory data will be reported separately.

The study demonstrated mean peak striatal D₂ receptor occupancy of approximately 40% with a range of peak occupancy up to 51%. These data extend previous findings of dose-related striatal D₂ receptor occupancy after a single dose across a lower dose range of ITI-007 measured in healthy volunteers: mean of 12% (up to 17%) at 10 mg, 19% (up to 20%) at 20 mg, 27% (up to 32%) at 30 mg, and 29% (up to 39%) at 40 mg (as published in Davis et al., Psychopharmacology 232:2863-2872, 2015).

Conference Call and Webcast Details

Intra-Cellular Therapies will host a live conference call and webcast today at 8:30 a.m. ET, during which management will discuss the top-line results of our Phase 3 trial and PET study. The live webcast and subsequent replay may be accessed by visiting the Company’s website at www.intracellulartherapies.com. Please connect to the Company’s website at least 5-10 minutes prior to the live webcast to ensure adequate time for any necessary software download. Alternatively, please call 1-844-835-6563 (U.S.) or 1-970-315-3916 (international) to listen to the live conference call. The conference ID number for the live call is 42973722. Please dial in approximately 10 minutes prior to the call.

About ITI-007

ITI-007 is our lead drug development candidate with mechanisms of action that, we believe, have the potential to yield a first-in-class antipsychotic therapy. In our pre-clinical and clinical trials to date, ITI-007 combines potent serotonin 5-HT_2A receptor antagonism, dopamine receptor phosphoprotein modulation (DPPM), glutamatergic modulation and serotonin reuptake inhibition into a single drug candidate for the treatment of acute and residual schizophrenia. At dopamine D₂ receptors, ITI-007 has been demonstrated to have dual properties and to act as both a post-synaptic antagonist and a pre-synaptic partial agonist. ITI-007 has also been demonstrated to stimulate phosphorylation of glutamatergic NMDA GluN_2B receptors in a mesolimbic specific manner. We believe that this regional selectivity in brain areas thought to mediate the efficacy of antipsychotic drugs, together with serotonergic, glutamatergic, and dopaminergic interactions, may result in antipsychotic efficacy for positive, negative, affective and cognitive symptoms associated with schizophrenia. The serotonin reuptake inhibition could allow for antidepressant activity for the treatment of schizoaffective disorder, co-morbid depression, and/or as a stand-alone treatment for major depressive disorder. We believe ITI-007 may also be useful for the treatment of bipolar disorder and other psychiatric and neurodegenerative disorders, particularly behavioral disturbances associated with dementia, autism and other CNS diseases.

About Schizophrenia

Schizophrenia is a disabling and chronic mental illness affecting over 1% of the world’s population. Schizophrenia is characterized by multiple symptoms during an acute phase of the disorder that can include so-called “positive” symptoms, such as hearing voices, disorganized thinking, grandiose beliefs and suspiciousness or paranoia. These symptoms can be accompanied by additional, harder-to-treat symptoms, such as social withdrawal and blunted emotional response and expression, collectively referred to as “negative” symptoms, difficulty concentrating or cognitive impairment, depression, and insomnia. Such residual symptoms often persist even after the acute positive symptoms subside, and contribute substantially to the social and employment disability associated with schizophrenia. Current antipsychotic medications provide some relief for the symptoms associated with the acute phase of the disorder, but they do not effectively treat the residual phase symptoms and psychosocial impairment associated with chronic schizophrenia. Currently available medications used to treat acute schizophrenia are limited in their use due to side effects that can include movement disorders, weight gain, metabolic disturbances, and cardiovascular disorders. There is an unmet medical need for new therapies that have improved side effect and efficacy profiles.

About Intra-Cellular Therapies Inc.  

Intra-Cellular Therapies is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases and diseases of the elderly, including Parkinson’s and Alzheimer’s disease. The Company is developing its lead drug candidate, ITI-007, for the treatment of schizophrenia, bipolar disorder, behavioral disturbances in dementia, depression, and other neuropsychiatric and neurological disorders. ITI-007, a first-in-class molecule, is in Phase 3 clinical development for the treatment of schizophrenia. The Company is also utilizing its phosphodiesterase platform and other proprietary chemistry platforms to develop drugs for the treatment of CNS and other disorders.

Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, our clinical and nonclinical development plans; the progress, timing and results of our clinical trials; the safety and efficacy of our product development candidates; our beliefs about the potential uses and benefits of ITI-007; our plans to present or report additional data; and our research and development efforts and plans under the caption “About Intra-Cellular Therapies.” All such forward-looking statements are based on management’s present expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include but are not limited to the following: our current and planned clinical trials, other studies for ITI-007, and our other product candidates may not be successful or may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety and/or efficacy in larger-scale or later clinical trials; our reliance on collaborative partners and other third parties for development of our product candidates; and the other risk factors discussed under the heading “Risk Factors” contained in our Annual Report on Form 10-K for the year ended December 31, 2014 filed with the Securities and Exchange Commission (SEC), as well as any updates to those risk factors filed from time to time in our periodic and current reports filed with the SEC. All statements contained in this press release are made only as of the date of this press release, and we do not intend to update this information unless required by law.

CONTACT: Juan Sanchez, M.D.
         Vice President
         Corporate Communications and
         Investor Relations of Intra-Cellular Therapies, Inc.
         Phone: 212-923-3344

         Burns McClellan, Inc.
         Lisa Burns (Investors)
         Justin Jackson (Media)
         jjackson@burnsmc.com
         212-213-0006

(GWPH) Announces Positive Proof of Concept Data in Schizophrenia

LONDON, Sept. 15, 2015  — GW Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP) (“GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced positive top line results from an exploratory Phase 2a placebo-controlled clinical trial of Cannabidiol (CBD) in 88 patients with schizophrenia who had previously failed to respond adequately to first line anti-psychotic medications. In the trial, patients remained on their anti-psychotic medication and were randomized to receive CBD or placebo as adjunct therapy.

Over a series of exploratory endpoints, CBD was consistently superior to placebo, with the most notable differences being in the PANSS positive sub-scale (p=0.018), the Clinical Global Impression of Severity (p=0.04) and Clinical Global Impression of Improvement (p=0.02). The proportion of responders (improvement in PANSS Total score greater than 20%) on CBD was higher than that of participants on placebo, with an Odds Ratio of 2.65. In the area of cognition, CBD was superior to placebo (p=0.07) with marked differences being seen in sub-domains of particular relevance to improving the outlook for people suffering with schizophrenia. With respect to negative symptoms, the Scale for Assessment of Negative Symptoms showed a trend in favour of CBD which reached statistical significance for patients taking CBD together with one of the leading first line anti-psychotic medications. The majority of other endpoints in the study were in favor of CBD and approached statistical significance in many cases.

The safety profile of CBD was particularly reassuring, with no serious adverse events and an overall frequency of adverse events very similar to placebo. The most common adverse events (occurring in 5% or more patients resulting from all causes) were diarrhea (9.3% CBD vs 4.4% placebo), nausea (7% CBD vs 0% placebo), headache (7% CBD vs 8.9% placebo) and somnolence (0% CBD vs 6.7% placebo). There were two withdrawals from the study due to treatment-related adverse events, one on CBD and the other on placebo.

A series of sub-group analyses have been performed to identify predictors for a successful outcome to treatment with CBD in this challenging patient population. These provide insight into the differential effects of CBD in combination with specific anti-psychotic medications, as well as the nature of endpoints that are most responsive to cannabinoid treatment.

“The addition of Cannabidiol to the medication of patients who were only partially responsive to standard anti-psychotic treatment produced significant improvements in outcome measures compared with placebo,” stated Professor Philip McGuire, Head of the Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, and Principal Investigator of the study. “Moreover, these improvements were not associated with adverse effects. “The results are of particular interest because the pharmacology of CBD is distinct from existing anti-psychotic medications, all of which act via effects on dopamine receptors.”

“These findings further reinforce the potential role of cannabinoids in the field of neuropsychiatric disease,” stated Justin Gover, GW’s Chief Executive Officer. “We believe that the signals of efficacy demonstrated in this trial, together with a notably reassuring safety profile, provide GW with the prospect of new and distinct cannabinoid neuropsychiatric product pipeline opportunity. Similar to our approach for Epidiolex, we believe that our future research in this area may lie within pediatric orphan neuropsychiatric indications and we intend to explore this as a focus for future trials.”

The multi-center, double-blind, placebo-controlled trial enrolled a total of 88 patients who were treated over a period of six weeks. Participants must have been treated for a minimum of four weeks on a first line anti-psychotic medication and still have a PANSS Total score in excess of 60. As a Phase 2a proof of concept study, there was no single primary endpoint, but a series of exploratory endpoints.

This trial followed extensive pre-clinical research conducted by GW since 2007 into the effects of cannabinoids in psychiatric disease. This research showed CBD to have notable anti-psychotic effects in accepted pre-clinical models of schizophrenia, and also provides indicators that there is potential to enhance the effect of CBD with additional cannabinoids. Previously published studies have suggested that CBD may have useful efficacy either as monotherapy or in combination with first line anti-psychotic agents¹.

GW’s portfolio of intellectual property related to the use of cannabinoids in schizophrenia includes a U.S. patent issued in April 2015 protecting the use of CBD and other cannabinoids in combination with other anti-psychotic medications for use in the prevention or treatment of psychosis and psychotic disorders. This patent provides exclusivity until March 2029. An additional patent has been filed based on the findings from this study.

About GW Pharmaceuticals plc

Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex^®, which is approved for the treatment of spasticity due to multiple sclerosis in 27 countries outside the United States. GW is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex^® (CBD or cannabidiol), which is in Phase 3 clinical development for the treatment of Dravet syndrome and Lennox-Gastaut syndrome and which is also expected to enter Phase 3 clinical trials in the treatment of Tuberous Sclerosis Complex. GW has a deep pipeline of additional cannabinoid product candidates which includes Sativex in Phase 3 clinical development as a potential treatment of pain associated with advanced cancer, as well as compounds in Phase 1 and 2 trials for glioma, type 2 diabetes, and schizophrenia. For further information, please visit www.gwpharm.com.

Forward-looking statements

This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including statements regarding the therapeutic benefit, safety profile and commercial value of the company’s investigational drug candidate cannabidiol, the development and commercialization of cannabidiol, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex®, Epidiolex®, and other products by consumer and medical professionals. A further list and description of risks, uncertainties and other risks associated with an investment in GW can be found in GW’s filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

CONTACT: Enquiries:

         GW Pharmaceuticals plc
         (Today)  +44 20 3727 1000
         Stephen Schultz, VP Investor Relations (U.S.)
         917 280 2424 / 401 500 6570

         FTI Consulting (Media Enquiries)
         Ben Atwell / Simon Conway / John Dineen (UK)
         + 44 20 3727 1000