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(INNL) Appoints Tony Zook CEO, Progresses Toward Becoming Commercially Fully-Integrated

Michael Myers Appointed as Head of Portfolio Operations to Continue Guiding Late-Stage Clinical Programs

ATHLONE, Ireland, Dec. 8, 2014  — Innocoll AG (Nasdaq:INNL) today announced that Tony Zook, formerly executive vice president, Global Commercial Operations, at AstraZeneca, has been appointed chief executive officer effectively immediately. Michael Myers, will continue with the company as head of Portfolio Operations. The executive changes were made to better position the company as its pipeline advances to late-stage clinical development and Innocoll prepares to become a fully-integrated specialty pharmaceutical company.

“Having the right people in executive positions has been an important topic during board meetings, especially due to the rapid progress at the company,” said Jonathan Symonds, chairman of the Board of Directors. “Michael and his team are to be commended for successfully advancing our pipeline. As we looked forward, the Board and the current management team planned to appoint an experienced senior pharmaceutical executive as CEO to manage the company’s evolution to a commercial-stage company. I worked with Tony during his time at AstraZeneca and he is a highly experienced and accomplished pharmaceutical executive with proven ability to manage both commercial and development organizations and successfully develop and launch innovative new medicines. As we were rapidly approaching the point where we will have multiple late stage opportunities in our pipeline, we believed we needed to move quickly with this exciting appointment.”

Michael Myers, Head of Portfolio Operations, and former chief executive officer said, “The opportunity to have Tony join Innocoll adds significant depth and experience to our executive team as we advance toward our goal of becoming a fully integrated pharmaceutical company. I look forward to working with Tony, on behalf of the entire company and its shareholders, to reach our business objectives.”

Mr. Zook has extensive pharmaceutical executive management, commercialization and marketing experience. He held several executive positions at AstraZeneca including executive vice president of Global Commercial Operations from 2010 to 2013, president and chief executive officer of the North American division from 2007 to 2010 and president of Medimmune from 2008 to 2010. Prior to joining Innocoll, Mr. Zook was chief executive officer and member of the Board of Directors of Vivus, Inc. in 2013. He has served or continues to serve on several boards including the boards of AltheRx, Inhibikase, Rib-X Pharmaceuticals, the National Pharmaceutical Council, PhRMA, the Pennsylvania Division of the American Cancer Society and his alma mater, Frostburg State University. Mr. Zook earned a B.S. degree from Frostburg State University and an A.A. degree in chemical engineering from Pennsylvania State University.

“I am excited to be joining the Innocoll team at this time in the company’s development,” said Mr. Zook. “Our late-clinical stage pipeline, which includes XaraColl, Cogenzia and CollaGUARD, is particularly promising as each candidate addresses patient needs in large global markets that are underserved today. I look forward to working with the Innocoll team to move our clinical candidates forward with the goal of bringing these important products to patients and their physicians in the near future.”

About Innocoll AG

Innocoll is a global, commercial-stage, specialty pharmaceutical company. The Company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The Company’s late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl® for the treatment of post-operative pain; Cogenzia® for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The Company’s approved products include: CollaGUARD(Ex-US), Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, which are sold through strategic partnerships with various partners including Takeda, Biomet, and Jazz Pharmaceuticals.

CollaRx®, Collatamp®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, Cogenzia® LidoColl®, LiquiColl®, Septocoll®, and XaraColl® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the Company.

Forward-looking Statements

“Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the development of the Company’s product candidates, such as the timing and conduct of the Company’s Phase 3 clinical trials of XaraColl for the treatment of post operative pain and Cogenzia for the adjuvant treatment of diabetic foot infections, and clinical studies of CollaGUARD, our barrier for the prevention of post-surgical adhesions, pre-commercial activities, the advancement of the company’s earlier stage pipeline, future sales of CollatampG, CollaGUARD, RegenePro, Septocoll or other approved or marketed products, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including statements about the clinical trials of our product candidates. Such forward-looking statements involve substantial risks and uncertainties that could cause Innocoll’s clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the timing and costs involved in commercializing our products and product candidates, the initiation and conduct of clinical trials, delays in potential approvals by FDA of the commencement of trials, availability of data from clinical trials, positive results from such trials and expectations for regulatory approvals, the Company’s scientific approach and general development progress, the composition of the company’s supervisory board, the availability or commercial potential of the Company’s product candidates, the sufficiency of cash resources and need for additional financing or other actions and other factors discussed in the “Risk Factors” section of the final prospectus for the Company’s IPO, which is on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this release.”

CONTACT: Corporate:
         Denise Carter
         Executive Vice President Business Development
         and Corporate Affairs
         T: (215) 765-0149
         E: dcarter@innocollinc.com

         Investor relations:
         Robert Flamm, Ph.D.
         Senior Vice President
         Russo Partners, LLC.
         T: (212) 845-4226
         E: Robert.flamm@russopartnersllc.com
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(CAPN) Presents CoSense® Data at the 2014 American Society of Hematology Annual Meeting

REDWOOD CITY, Calif., Dec. 8, 2014  — Capnia, Inc. (NASDAQ: CAPN), focused on the development of medical diagnostics based on its proprietary Sensalyze™ technology for precision metering of gas flow, today announced a poster presentation at the 2014 American Society of Hematology (ASH) Annual Meeting and Exposition, December 6-9, 2014, in San Francisco. The poster describes positive proof-of-concept data for the Company’s CoSense® ETCO Monitor in patients with sickle cell anemia (SCA), a disorder in which patients have chronic hemolysis. CoSense is a portable, non-invasive device that rapidly and accurately measures carbon monoxide in the exhaled breath and therefore measures the rate of hemolysis.

“Sickle cell anemia is the most common inherited lethal disorder and screening for it in resource constrained settings is a significant problem,” said Ashutosh Lal, M.D., Director, Thalassemia Program, The University of California San Francisco, Benioff Children’s Hospital Oakland, and the lead investigator for the study.  “Early mortality remains a significant problem in SCA patients in the areas of the world where the disease is most prevalent.  These findings provide scientific support for the further development of exhaled carbon monoxide measurement to monitor hemolysis in children with SCA and as a potential point-of-care screening test for SCA.”

“CoSense is currently FDA cleared and CE marked for the detection of hemolysis by measuring end-tidal carbon monoxide, or ETCO,” said Anish Bhatnagar, M.D., Chief Executive Officer of Capnia.  “Based on the data from this study, CoSense can be an important tool for non-invasive point of care screening for babies at risk for SCA. We believe CoSense has potential applications in the monitoring of a range of diseases involving hemolysis and altered bilirubin metabolism and we appreciate being able to share these important findings with the hematology community at ASH this year.”

The following is a summary of the data presented at ASH:

Title: Elevated End-Tidal Carbon Monoxide Concentration in Children with Sickle Cell Anemia
Abstract #: 1390
Session: 114
Date and Time: Saturday, December 6, 2014, 5:30 PM-7:30 PM PT
Summary: Carbon monoxide (CO) produced during oxygen-dependent cleavage of porphyrin ring of heme is excreted in exhaled breath. The catabolism of heme is increased when red blood cells are destroyed at an accelerated rate. Thus, quantifying CO in exhaled breath could serve as an indicator of hemolysis.  However, the requirement for forced breath sample has precluded measurement of exhaled CO in young children. The goal of this single-center, open-label, non-randomized study was to assess passively-measured end-tidal CO concentration (ETCOc) in children with SCA.  In this study, 32 children (16 with SCA and 16 controls) ranging in age from 5-14 years were evaluated.

The study results demonstrated that the mean ETCOc was 5-fold higher in SCA compared with controls, with little overlap seen between the groups.  In addition, ETCOc measurements provided both sensitivity and specificity equal to 93.8% for distinguishing SCA from healthy children.  These results suggest that ETCOc may be a valuable tool for non-invasive monitoring of the severity of hemolysis in SCA and that ETCOc has potential for use as a point-of-care screening test for SCA.

About Capnia

Capnia, Inc. develops and commercializes diagnostics based on its proprietary Sensalyze™ technology for precision metering of gas flow.  Capnia’s lead product is CoSense®, which aids in the diagnosis of hemolysis, a dangerous condition in which red blood cells degrade rapidly. CoSense is a portable, non-invasive device that rapidly and accurately measures carbon monoxide in exhaled breath. CoSense has 510(k) clearance from the FDA and was launched in the U.S. in October 2014.  CoSense has also received CE Mark approval for sale in the E.U.

Forward-Looking Statements

This communication contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned product development and clinical trials; the timing of, and our ability to make, regulatory filings and obtain and maintain regulatory approvals for our product candidates; our intellectual property position; the degree of clinical utility of our products, particularly in specific patient populations; our ability to develop commercial functions; expectations regarding product launch and revenue; our results of operations, cash needs, and spending of the proceeds from this offering; financial condition, liquidity, prospects, growth and strategies; the industry in which we operate; and the trends that may affect the industry or us.

We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that 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 presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate.

Capnia Contact:
David O’Toole
Chief Financial Officer
Capnia, Inc.
(650) 353-5146
dotoole@capnia.com

Investor Relations Contact:
Matthew Haines
Argot Partners
(646) 681-8192
matthew@argotpartners.com

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(VTSS) Facilitates Adoption of MEF Third Network Vision

Recent analyst reports estimate the Carrier software-defined networking (SDN) and network functions virtualization (NFV) market will exceed $11 billion by 2018, with a growth rate of nearly 90% from today. While service provider network virtualization is still in developing stages, SDN and NFV will ultimately enable more agile, automated, and faster creation of revenue-generating services in carrier networks.

Anticipating these disruptive market trends, Vitesse Semiconductor Corporation (Nasdaq: VTSS), a leading provider of IC solutions to advance “Ethernet Everywhere” in Carrier, Enterprise and Internet of Things (IoT) networks, announced availability of an open, full duplex machine-programmable application programming interface (API) – JSON/RPC – for its CEServices™ software. This is an essential tool for enabling open-source SDN controllers to program all essential functions in an automated, programmatic model. CEServices is a comprehensive, mature protocol stack for easy provisioning and management of Carrier Ethernet business services.

With the JSON/RPC machine-to-machine (M2M) protocol, CEServices eclipses the rudimentary forwarding behavior of low-level APIs like OpenFlow, and extends SDN controller programming capabilities to:

  • End-to-end service creation
  • Operations, Administration and Maintenance (OAM)
  • Quality of Service (QoS)

“Vitesse’s turnkey CEServices software and Serval Carrier Ethernet switch engine have already been integrated into the popular OpenDaylight controller, and is in customer SDN/NFV trials with large service providers,” said Uday Mudoi, vice president of product marketing at Vitesse. “We recognize the criticality of service agility in global networks and are committed to helping define open and standardized APIs as part of the MEF Third Network Initiative.”

About Vitesse

Vitesse (Nasdaq: VTSS) designs a diverse portfolio of high-performance semiconductors, application software, and integrated turnkey systems solutions for Carrier, Enterprise and Internet of Things (IoT) networks worldwide. Vitesse products enable the fastest-growing network infrastructure markets including Mobile Access/IP Edge, Cloud Access and Industrial-IoT Networking. Visit www.vitesse.com or follow us on Twitter @VitesseSemi.

Vitesse is a registered trademark and CEServices and Serval are trademarks of Vitesse Semiconductor Corporation in the United States and other jurisdictions. All other trademarks or registered trademarks mentioned herein are the property of their respective holders.

VTSS-G

Vitesse Semiconductor
Michelle Lozada, +1.805.388.3700
pressrelations@vitesse.com
www.vitesse.com
or
Agency Contact (Americas):
Interprose PR
Lisa McCausland, +1.303.888.2137
lisa.mccausland@interprosepr.com
www.interprosepr.com
or
Agency Contact (China):
Beijing New Synergy Consulting
Sharon Hu
+86 10 88144519/20 x 808
mhu@1AND7.com
www.1AND7.com

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(XLRN) New Data in Myelodysplastic Syndromes At 56th American Society of Hematology

Celgene Corporation (NASDAQ:CELG) and Acceleron Pharma Inc. (NASDAQ:XLRN) today announced preliminary data from ongoing phase 2 clinical trials in patients with lower risk myelodysplastic syndromes (MDS) at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition. In his oral presentation, Dr. Uwe Platzbecker showed that patients with lower risk MDS treated with luspatercept achieved increased hemoglobin levels and transfusion independence. In a separate poster presentation, Dr. Rami Komrokji showed that lower risk MDS patients who were treated with sotatercept also achieved increased hemoglobin levels and transfusion independence. Celgene and Acceleron are jointly developing luspatercept and sotatercept.

“These results in lower risk MDS patients are very exciting,” said Uwe Platzbecker, M.D., Professor of Hematology and Head of the MDS program at the University Hospital in Dresden, Germany and coordinating principal investigator of the luspatercept PACE-MDS study. “Sotatercept and luspatercept may be useful early in the treatment of lower risk MDS patients, either as the initial treatment for anemia or in patients who do not respond or become refractory to treatment with ESAs. These investigational therapeutics have been very well-tolerated and therefore have the potential to benefit many MDS patients.”

Luspatercept Data Presented at ASH

In this study, luspatercept was evaluated in patients with low- or intermediate-1 risk MDS.

A total of 26 patients were treated in this dose-finding stage of the study in which luspatercept was administered subcutaneously once every 3 weeks for up to 5 doses (16 weeks) at doses of 0.125 (n=3), 0.25 (n=3), 0.5 (n=3), 0.75 (n=6), 1.0 (n=3) 1.33 (n=6), or 1.75 (n=2) mg/kg. Of these 26 patients, 19 had a high transfusion burden (≥4 units RBC/8 weeks) and 7 had a low transfusion burden (<4 units RBC/8 weeks). 54% of patients had been treated previously with erythropoiesis stimulating agents (ESA) and 19% of patients had previously been treated with lenalidomide.

Low Transfusion Burden (LTB) Patients:

  • 4 of 5 (80%) LTB patients treated with doses of 0.75-1.75 mg/kg of luspatercept achieved the primary endpoint of hemoglobin increase ≥1.5 g/dL for ≥2 weeks in this 16 week study
  • Additionally, 2 of 5 (40%) of LTB patients achieved the International Working Group (IWG) Hematologic Improvement Erythroid (HI-E) response criteria of a hemoglobin increase ≥1.5 g/dL for ≥8 weeks
  • The mean maximum change for patients treated with luspatercept doses of 0.75. and 1.75 mg/kg was 2.2 and 3.5 g/dL, respectively
  • All 5 LTB patients treated with luspatercept doses of 0.75-1.75 mg/kg had received prior ESA

High Transfusion Burden (HTB) Patients:

  • 5 of 12 (42%) HTB patients treated with luspatercept doses of 0.75-1.75 mg/kg of achieved IWG HI-E criteria of a reduction of ≥4 units RBC over 8 weeks
  • 3 of 12 (25%) HTB patients treated with luspatercept doses of 0.75-1.75 mg/kg achieved transfusion independence for ≥8 weeks

Emerging markers of response:

  • As published earlier this year in Nature Medicine, the murine analog of luspatercept, RAP-536, can correct ineffective erythropoiesis in a mouse model of MDS
  • Splicing factor 3B1 (SF3B1) mutations are seen commonly in MDS patients with ring sideroblasts and are associated with ineffective erythropoiesis
  • Erythroid response (HI-E, IWG) was achieved in 41% of patients treated at ≥0.75 mg/kg. Erythroid response (HI-E, IWG) was achieved in 67% of patients with ring sideroblasts and SF3B1 mutations

The most common adverse events were diarrhea, muscle spasms, bone pain, fatigue, myalgia and nasopharyngitis. There were no drug-related serious adverse events. There was one possibly related grade 3 adverse event of blast cell count increase.

Sotatercept Data Presented at ASH

A second phase 2 study evaluated sotatercept in patients with low- or intermediate-1 risk MDS.

A total of 54 patients were treated in this dose-finding study in which sotatercept was administered subcutaneously once every 3 weeks at doses of 0.1 (n=7), 0.3 (n=6), 0.5 (n=21), and 1.0 (n=20) mg/kg. Of these 54 patients, 46 (85%) had a high transfusion burden (≥4 units RBC/8 weeks) and 8 (15%) had a low transfusion burden (<4 units RBC/8 weeks). 96% of patients had prior ESA, 57% had a prior hypomethylating agent, and 48% had prior lenalidomide.

Low Transfusion Burden (LTB) Patients:

  • 5 (63%) patients achieved a mean hemoglobin increase ≥1.5 g/dL and transfusion independence sustained for ≥ 8 weeks
  • Duration of transfusion independence ranged from 76 to 233 days
  • Maximum mean hemoglobin increases ranged from 1.9 to 4.4 g/dL

High Transfusion Burden (HTB) Patients:

  • 19 of 45 HTB patients (42%) achieved IWG HI-E criteria of a reduction ≥4 RBC units/8 weeks
  • 5 HTB patients (11%) achieved transfusion independence
  • Duration of transfusion independence ranged from 59 to 345+ days

The most common adverse events were fatigue/asthenia, headache, decreased appetite, nausea and dyspnea. 3 of 54 (6%) patients discontinued due to treatment emergent adverse events considered related to sotatercept. 1 patient with grade 2 hemolytic anemia; 1 patient with grade 3 hypertension; and 1 patient with grade 2 muscle weakness in the 0.3, 0.5, and 1.0 mg/kg dose groups, respectively.

About Luspatercept

Luspatercept is a modified activin receptor type IIB fusion protein that acts as a ligand trap for members in the Transforming Growth Factor-Beta (TGF-β) superfamily involved in the late stages of erythropoiesis (red blood cell production). Luspatercept regulates late-stage erythrocyte (red blood cell) precursor cell differentiation and maturation. This mechanism of action is distinct from that of erythropoietin (EPO), which stimulates the proliferation of early-stage erythrocyte precursor cells. Acceleron and Celgene are jointly developing luspatercept as part of a global collaboration. Luspatercept is currently in phase 2 clinical trials in patients with beta-thalassemia and in patients with myelodysplastic syndromes. For more information, please visit www.clinicaltrials.gov.

About Sotatercept

Sotatercept is an activin receptor type IIA fusion protein that acts as a ligand trap for members in the Transforming Growth Factor-Beta (TGF-β) superfamily involved in the late stages of erythropoiesis (red blood cell production). Sotatercept regulates late-stage erythrocyte (red blood cell) precursor cell differentiation and maturation. This mechanism of action is distinct from that of erythropoietin (EPO), which stimulates the proliferation of early-stage erythrocyte precursor cells. Acceleron and Celgene are jointly developing sotatercept as part of a global collaboration. Sotatercept is currently in multiple phase 2 clinical trials. For more information, please visit www.clinicaltrials.gov.

About Acceleron

Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel protein therapeutics for cancer and rare diseases. The company is a leader in understanding the biology of the Transforming Growth Factor-Beta (TGF-β) protein superfamily, a large and diverse group of molecules that are key regulators in the growth and repair of tissues throughout the human body, and in targeting these pathways to develop important new medicines. Acceleron has built a highly productive R&D platform that has generated innovative clinical and preclinical protein therapeutic candidates with novel mechanisms of action. These protein therapeutic candidates have the potential to significantly improve clinical outcomes for patients with cancer and rare diseases.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company’s website at www.celgene.com. Follow us on Twitter @Celgene as well.

Forward-Looking Statements

Acceleron:
Cautionary Note on Forward-Looking Statements

This press release includes forward-looking statements about the Company’s strategy, future plans and prospects, including statements regarding the development of the Company’s compounds, including luspatercept and sotatercept, and the Company’s TGF-β superfamily program generally, the timeline for clinical development and regulatory approval of the Company’s compounds, the expected timing for the reporting of data from ongoing trials, and the structure of the Company’s planned or pending clinical trials. The words “anticipate,” “appear,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks that the Company’s cash position will be insufficient to fund operations into the second half of 2017, that preclinical testing of the Company’s compounds and preliminary data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that data may not be available when we expect it to be, that the Company or its collaboration partner, Celgene, will be unable to successfully complete the clinical development of its compounds, that the development of the Company’s compounds will take longer or cost more than planned, that the Company may be delayed in initiating or completing any clinical trials, and that the Company’s compounds will not receive regulatory approval or become commercially successful products. Other risks and uncertainties include those identified under the heading “Risk Factors” included in the Company’s Annual Report on Form 10-K which was filed with the Securities and Exchange Commission (SEC) on March 17, 2014, and other filings that the Company may make with the SEC in the future. The forward-looking statements contained in this press release reflect the Company’s current views with respect to future events, and the Company does not undertake and specifically disclaims any obligation to update any forward-looking statements.

Celgene:

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.

 

For Celgene:
Investors: 908-673-9628
investors@celgene.com
or
Media: 908-673-2275
media@celgene.com
or
For Acceleron
Investors:
Acceleron Pharma
Steven Ertel, 617-649-9234
Chief Business Officer
or
Media:
Suda Communications LLC
Maureen L. Suda, 585-387-9248

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(CALA) Preclinical Study Findings for CB-839 Presented At 56th American Society of Hematology

-Potential Biomarkers of Response to CB-839 Identified in Myeloma Cells

-Synergy of CB-839 With Pomalidomide Demonstrated in Multiple Myeloma Models

SOUTH SAN FRANCISCO, Calif., Dec. 8, 2014  — Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, today announced preclinical data for its lead anti-cancer therapeutic candidate, CB-839, at the American Society of Hematology (ASH) Annual Meeting and Exposition in San Francisco, California. CB-839 is a potent, selective, orally bioavailable glutaminase inhibitor in phase I clinical trials.

“Data presented at this week’s ASH provides us with valuable insights into cellular metabolic properties that could ultimately direct our development of CB-839 towards the patients most likely to benefit from treatment. We have identified pyruvate carboxylase expression and functional read-outs of the mTORC1 pathway as possible biomarkers in our clinical studies of CB-839. Additionally, based on the pronounced synergy we observed preclinically with CB-839 and IMiDs, we are planning to initiate a Phase 1b trial treating myeloma patients with CB-839 plus pomalidomide and dexamethasone,” said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera.

Preclinical data was presented in a poster titled, “Biomarkers of Response to the Glutaminase Inhibitor CB-839 in Multiple Myeloma Cells,” on December 7, 2014 (Abstract #3429). High pyruvate carboxylase expression conferred inherent resistance to CB-839; those myeloma cells that did not express high levels of pyruvate carboxylase were sensitive to CB-839. In addition, the baseline metabolic profiles of CB-839 sensitive multiple myeloma cells were different from that of insensitive cells, suggesting that nutrient state and energy storage level in myeloma cells is an important factor in determining response to CB-839. Finally, the metabolic stress induced by CB-839 led to sustained inhibition of the nutrient senor mTORC1 in sensitive cells, with downstream effects on protein synthesis, nucleotide production and glycolysis.

Calithera also presented today at ASH the results of a study investigating the preclinical anti-tumor activity of CB-839 in combination with pomalidomide, demonstrating synergistic antiproliferative effects in IMiD-resistant cells in a poster titled, “Glutaminase Inhibitor CB-839 Synergizes with Pomalidomide in Preclinical Multiple Myeloma Models,” (Abstract #4720). The combination of CB-839 and pomalidomide produced enhanced effects on metabolic and signal transduction pathways likely contributing to the synergistic anti-proliferative activity.  In addition, in a multiple myeloma xenograft model, CB-839 showed significant single agent anti-tumor efficacy and displayed enhanced anti-tumor activity when combined with pomalidomide.

In addition, two posters were presented by Calithera’s collaborators. Details for the presentations are as follows:

Anti-Myeloma Activity of a Novel Glutaminase Inhibitor CB-839
Abstract #3439
Deepika Sharma Das, Ph.D., Dana Farber Cancer Institute
Poster Session 652 Myeloma: Pathophysiology and Pre-Clinical studies, excluding Therapy: Poster II

Efficacy of Novel Glutaminase Inhibitor CB-839 in Acute Myeloid Leukemia
Abstract #3763
Polina Matre, Ph.D., MD Anderson Cancer Center
Poster Session 616 Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III

About Calithera Biosciences

Calithera Biosciences is a clinical-stage company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology. Calithera’s lead clinical candidate, CB-839, is a first-in-class inhibitor of glutaminase, a critical enzyme in tumor metabolism, and is currently being tested in patients with solid and hematological cancers. Calithera Biosciences is headquartered in South San Francisco. For more information about Calithera Biosciences, please visit www.calithera.com.

Forward Looking Statements

This news release contains forward-looking statements by Calithera that involve risks and uncertainties. These statements include those related to the advancement of Calithera’s tumor metabolism and tumor immunology therapeutics through clinical development and  Calithera’s plan to initiate a Phase 1b trial treating myeloma patients with CB-839 plus pomalidomide and dexamethasone; Actual results may differ from Calithera’s expectations and important factors that could cause actual results to differ materially. Calithera’s product candidates may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. In particular, future clinical trials may not show the synergy Calithera observed preclinically with CB-839 and IMiDs.  Furthermore, Calithera’s product candidates may not be beneficial to patients or successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera’s stock price. Additional information concerning these and other risk factors affecting Calithera’s business can be found in Calithera’s Quarterly Report on Form 10-Q for the period ended September 30, 2014 and other periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

CONTACT: Jennifer McNealey
ir@Calithera.com
650-870-1071

Monday, December 8th, 2014 Uncategorized Comments Off on (CALA) Preclinical Study Findings for CB-839 Presented At 56th American Society of Hematology

(CBST) Acquisition By (MRK) Moves Forward, At $102 Per Share, Cash

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Cubist Pharmaceuticals, Inc. (NASDAQ:CBST) today announced that the companies have entered into a definitive agreement under which Merck will acquire Cubist for $102 per share in cash, which represents a 35 percent premium to Cubist’s average stock price for the most recent five trading days.

Unanimously approved by the boards of directors of both companies, the transaction has an equity valuation of $8.4 billion and will also include $1.1 billion in net debt (based on projected cash balances) and other considerations for a total transaction value of approximately $9.5 billion.

“Cubist is a global leader in antibiotics and has built a strong portfolio of both marketed and late-stage pipeline medicines,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. “Combining this expertise with Merck’s strong capabilities and global reach will enable us to create a stronger position in hospital acute care while addressing critical areas of unmet medical need, such as antibiotic resistance.”

“Combining with Merck is an exciting opportunity to accelerate Cubist’s established leadership in antibiotics and deliver significant, certain and immediate value to shareholders,” said Michael Bonney, chief executive officer, Cubist. “We have a deep respect for Merck, and it is clear that they share our commitment to addressing the growing, global problem we are facing in combating antibiotic-resistant bacteria. Under Merck’s robust commercial platform, global reach and scientific expertise, we believe Cubist’s programs can thrive. We’re proud of the company that our team has built and are confident that Cubist’s important mission and focus on significant unmet medical needs will continue.”

For more than 20 years, Cubist has been committed to global public health through the discovery, development and supply of antibiotics to treat serious and potentially life-threatening infections caused by a broad range of increasingly drug-resistant bacteria. Cubist’s antibiotic CUBICIN®, the only approved once-a-day therapy for both S. aureus bacteremia and complicated skin and skin structure infections (cSSSI), has been used to treat more than two million patients and continues to be an important therapy in the acute care environment. Cubist’s in-line and late-stage pipeline of anti-infective medicines, including ZERBAXA which is pending approval from the U.S. Food and Drug Administration, will enhance Merck’s hospital acute care business in a variety of therapeutic areas, including Gram-positive and Gram-negative multi-drug resistant infections.

The acquisition of Cubist creates strong fundamental value with return on capital in excess of Merck’s hurdle rate within a few years of closing. Merck expects the acquisition to add more than $1 billion of revenue to its 2015 base. While the transaction will be neutral to non-GAAP EPS in 2015, Merck expects it to be significantly accretive to non-GAAP EPS in 2016 and beyond. The acquisition will be accretive to both Merck’s sales and earnings growth.

Cubist complements Merck’s strategy and the global initiative Merck launched last year, particularly in the area of sharpening its commercial focus on key therapeutic areas that have the potential to deliver the greatest return on investment. With the company’s long-standing leadership in anti-infectives as well as its customer-focused operating model, Merck identified the hospital acute care segment as one of the company’s key priority areas in which it believes it can have the greatest impact in addressing significant unmet medical needs while delivering the greatest value to customers and society.

Merck strategically focused on acute care within the larger hospital setting as a top priority because of the significant unmet need and the unique opportunities for Merck to improve patient care and manage costs in this setting with its in-line portfolio, promising pipeline and its customer capabilities.

Hospitals are a central hub for healthcare delivery around the world and currently represent 25 percent of overall healthcare spend. Merck believes now is an optimal time to significantly grow its hospital acute care presence because of the positive regulatory and reimbursement trends in the hospital setting and the increasingly important role that hospitals are expected to provide in healthcare overall.

For the first three quarters of 2014 compared to 2013, Merck’s hospital acute care portfolio grew by more than 10 percent, excluding the impact of foreign exchange. Key products in Merck’s hospital acute care portfolio include several antibiotics and antifungals, as well as BRIDION® (sugammadex), which is marketed outside the United States and is currently under regulatory review in the United States. In addition, Merck has continued to invest in its hospital acute care pipeline and has several candidates, including actoxumab/bezlotoxumab (MK-3415A), an investigational combination of therapeutic antibodies targeting two C.difficile pathogenic toxins (A and B), which is being evaluated in clinical trials for the prevention of recurrence of C.difficile infection; and relebactam (MK-7655), an investigational class A and C beta-lactamase inhibitor being evaluated in clinical trials for the treatment of severe bacterial infections.

Under the terms of the agreement, Merck, through a subsidiary, will initiate a tender offer to acquire all outstanding shares of Cubist Pharmaceuticals, Inc. The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of Cubist’s outstanding shares (assuming the exercise of all options), the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. Upon the completion of the tender offer, Merck will acquire all remaining shares through a second-step merger without the need for a stockholder vote under Delaware law. The companies expect the transaction to close in the first quarter of 2015.

Important Information about the Tender Offer

The tender offer for the outstanding shares of Cubist has not yet commenced. This news release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares, nor is it a substitute for the tender offer materials that Merck and its subsidiary will file with the Securities and Exchange Commission (SEC). At the time the planned tender offer is commenced, a tender offer statement on Schedule TO will be filed by Merck with the SEC, and Cubist will file a solicitation/recommendation statement on Schedule 14D-9 with respect to the tender offer. The tender offer materials (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 holders of Cubist common stock shares are urged to read carefully when they become available, as each may be amended or supplemented from time to time and because they will contain important information that holders of shares of Cubist common stock should consider before making any decision regarding tendering their shares. The tender offer materials will be made available to Cubist’s stockholders at no expense to them. In addition, all of those materials (and other tender offer documents filed with the SEC) will be made available at no charge on the SEC’s website at www.sec.gov. Additional copies of the tender offer materials may be obtained at no charge by contacting Merck at 2000 Galloping Hill Road, Kenilworth, N.J., 07033 or by phoning (908) 740-4000. In addition, Merck and Cubist file annual, quarterly and current reports and other information with the SEC. You may read and copy any reports or other information filed by Merck or Cubist at the SEC public reference room at 100 F Street, N.E., Washington, D.C., 20549. For further information on the SEC public reference room, please call 1-800-SEC-0330. Merck’s and Cubist’s filings with the SEC are also available to the public from commercial document-retrieval services and at the SEC’s website at www.sec.gov.

In this transaction, J.P. Morgan and Deutsche Bank served as financial advisors to Merck, and Hughes Hubbard & Reed LLP and Baker & McKenzie served as its legal advisors. Morgan Stanley & Co. LLC and Goldman, Sachs & Co. served as financial advisors to Cubist, and Ropes & Gray served as its legal advisor.

Investor Briefing Call

Merck will hold a call with institutional investors and analysts at 8:00 a.m. EST today, Dec. 8, 2014. Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 48773641. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 48773641. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

About Merck

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

Merck Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the timing and closing of the tender offer and the merger transactions, the ability of Merck to complete the transactions considering the various closing conditions, and any assumptions underlying any of the foregoing. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the exposure to litigation, including patent litigation, and/or regulatory actions; timing of the tender offer and merger; uncertainties as to how many Cubist stockholders will tender shares in the tender offer; the possibility that competing offer may be made; the possibility that various closing conditions to transactions may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transactions; or that a material adverse effect occurs with respect to Cubist.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2013 Annual Report on Form 10-K and the company’s other filings with the SEC available at the SEC’s Internet site (www.sec.gov).

About Cubist

Cubist Pharmaceuticals, Inc. is a global biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address significant unmet medical needs in the acute care environment. Cubist’s corporate headquarters is based in Lexington, Massachusetts, with international headquarters located in Zurich, Switzerland. Additional information can be found at Cubist’s web site at www.cubist.com. Also, connect with Cubist on Twitter @cubistbiopharma and @cubistcareers, LinkedIn, or YouTube.

Cubist Forward-Looking Statement

This press release contains forward-looking statements. Any statements contained herein which do not describe historical facts, including but not limited to, statements regarding the timing and closing of the tender offer and the merger transactions and the ability of Cubist to complete the transaction are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, among others: the risk that Cubist stockholders will not tender shares in the tender offer; the possibility that competing offers may be made; the possibility that various closing conditions may not be satisfied or waived; or that a material adverse effect occurs with respect to Cubist; and those additional factors discussed in Cubist’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the SEC. Cubist cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Cubist undertakes no obligation to update or revise any of these statements.

 

Merck
Media Contacts:
Lainie Keller, 908-406-1459
or
Steve Cragle, 908-740-1801
or
Investor Contacts:
Joe Romanelli, 908-740-1986
or
Justin Holko, 908-740-1879
or
Cubist
Media Contact:
Julie DiCarlo, 781-860-8063
or
Investor Contact:
Eileen C. McIntyre, 781-860-8100

Monday, December 8th, 2014 Uncategorized Comments Off on (CBST) Acquisition By (MRK) Moves Forward, At $102 Per Share, Cash

(KOOL) Appoints Mr. Denis Michael Rhein to Its Board of Directors

RANCHO CORDOVA, Calif., Dec. 5, 2014  — Cesca Therapeutics Inc. (Nasdaq:KOOL), an autologous cell-based regenerative medicine company, today announced that Mr. Denis Michael Rhein (54) has been appointed to the Company’s Board of Directors.

Mr. Rhein has over 30 years of corporate banking and securities experience at Deutsche Bank AG in Frankfurt, Germany. He served in various executive management positions including Managing Director, Senior Client Executive of Asset and Wealth Management, Global Head of Hedge Fund Research, Head of Alternative Investments, and Head of Product Development.

Mr. Rhein is the founder and Director of EMR Vermögensverwaltung GmbH, an investment management company. He is also the founder, Principal Shareholder and Director of Illumisound GmbH, an alternative energy efficient commercial lighting company. Mr. Rhein was a director of TotipotentRX Corporation from 2012 until the merger that resulted in the formation of Cesca Therapeutics in February 2014.

Robin C. Stracey, Chief Executive Officer and Director of Cesca Therapeutics said, “We are delighted to have Michael join our Board of Directors. His thirty years of international experience at one of Germany’s largest and most prestigious banks will bring valuable perspective to the Board. We look forward to working with him as we execute the Company’s growth strategy.”

About Cesca Therapeutics Inc.

Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development, and commercialization of autologous cell-based therapeutics for use in regenerative medicine. We are a leader in developing and manufacturing automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapy products. These include:

  • SurgWerksPlatform, proprietary stem cell therapy point-of-care kit systems for treating vascular and orthopedic indications that integrate the following indication specific systems:
    • Cell harvesting
    • Cell processing and selection
    • Cell diagnostics
    • Cell delivery
  • CellWerksTM Platform, a proprietary stem cell laboratory kit for processing target cells used in the treatments of oncological and hematological disorders.
  • AXP® AutoXpress® Platform (AXP), a proprietary family of automated devices that includes the AXP and the MXP® MarrowXpress® and companion sterile blood processing disposables for harvesting stem cells in closed systems. The AXP device is used for the processing of cord blood.
  • The MarrowXpress® Platform (MXP), a derivative product of the AXP and its accompanying disposable bag set, isolates and concentrates stem cells from bone marrow. Self-powered and microprocessor-controlled, the MXP contains flow control optical sensors that volume-reduces blood from bone marrow to a user defined volume in 30 minutes, while retaining over 90% of the MNCs.
  • The Res-Q™ 60 (Res-Q), a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates and whole blood for platelet rich plasma (PRP).
  • The BioArchive® System, an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries for cryopreserving and archiving cord blood stem cell units for transplant.

Forward Looking Statement

The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by Cesca Therapeutics’ forward-looking statements is set forth under the caption “Risk Factors” in Cesca Therapeutics annual report on Form 10-K and other reports it files with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.

CONTACT: Cesca Therapeutics Inc.
         http://www.cescatherapeutics.com
         Investor Contact: Kirin Smith, ProActive Capital Group
         + 1-646-863-6519, or ir@cescatherapeutics.com
Friday, December 5th, 2014 Uncategorized Comments Off on (KOOL) Appoints Mr. Denis Michael Rhein to Its Board of Directors

(ICPT) Publication of Meta-Analysis From the Global PBC Study Group in Gastroenterology

– Largest Analysis of Data from Patients with Primary Biliary Cirrhosis

– Alkaline Phosphatase (ALP) and Bilirubin Shown to Significantly Predict Clinical Outcomes

NEW YORK, Dec. 5, 2014  — Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic liver and intestinal diseases, announced today the publication of the meta-analysis performed by the Global Primary Biliary Cirrhosis Study Group (Global PBC Study Group) in the December issue of Gastroenterology. In the largest meta-analysis of individual PBC patient data conducted to date, researchers confirmed that levels of ALP and bilirubin predicted clinical outcomes of patients with PBC.

Of the 4,845 patients included in the analysis, 1,118 reached a clinical outcome defined as liver transplantation or death. For the first time, the researchers reported a log-linear association between ALP values and liver transplant-free survival. At one year after study enrollment, an ALP level of two times upper limit of normal (ULN) best predicted patient outcome (C statistic, 0.71) but not significantly better than other lower ALP thresholds such as 1.67 times ULN. Of patients with ALP levels less than or equal to two times ULN, 84% survived for over a ten year follow-up period compared with 62% of those with levels exceeding two times ULN (p < 0.0001). Elevated bilirubin levels were strongly predictive of a worse prognosis and only 41% of such patients had not had a liver transplant or died over the subsequent 10 years compared with 86% of patients with normal bilirubin levels (p < 0.0001).

The Global PBC Study Group analysis also showed that ALP and bilirubin were correlated with clinical outcomes consistently over time and in all the patient subgroups evaluated. Specifically, ALP was predictive of transplant-free survival in PBC patients both on and off standard of care treatment, those with histologically advanced or early stage disease, patients 45 years or younger or over 45 years at the time of diagnosis, female or male, and irrespective of the year of diagnosis.

“This study represents the largest international collaboration in PBC and provided us with a wealth of data supporting the use of this biochemical endpoint for therapeutic clinical trials,” said senior author Bettina Hansen, Ph.D., Department of Gastroenterology and Hepatology, Erasmus University Medical Centre in Rotterdam. “But the key takeaway from this analysis for everyday clinical practice is that the lower a patient’s ALP level and having a normal bilirubin level correlate with an improved prognosis for patients with PBC.”

The Global PBC Study Group consists of 15 leading PBC centers in eight countries that contributed to a clinical outcomes database of more than 6,000 patients with PBC. Data were analyzed under the direction of Dr. Bettina Hansen, Dr. Willem J. Lammers, Dr. Henk van Buuren and colleagues at Erasmus University Medical Centre in Rotterdam, the Netherlands. Intercept was a sponsor of this independent academic research program but was not involved in the study design, data collection, analysis or publication.

“We believe the Global PBC Study Group’s research supports the clinical relevance of a primary endpoint based on ALP and bilirubin in clinical trials of patients with PBC,” said David Shapiro, M.D., Chief Medical Officer of Intercept. “More broadly, it should enhance monitoring of disease progression and lead to better dialogue between clinicians and patients.”

“The work done by the Global PBC Study Group exemplifies the value of such cooperative initiatives in generating large clinical datasets that may provide evidence for the utility of proposed surrogate endpoints and a better understanding of the natural history of diseases such as PBC,” said Mark Pruzanski, M.D., CEO of Intercept. “We hope the Global PBC Study Group’s work continues in the future and would like to thank all of the researchers and patients involved in making such an invaluable contribution to the medical community’s understanding of this rare disease.”

About Primary Biliary Cirrhosis

PBC is an autoimmune liver disease that may progress to cirrhosis and liver failure, and it is currently the second leading indication for liver transplant among women in the United States. It is primarily a disease of women, afflicting approximately one in 1,000 women over the age of 40. Ursodiol is the only approved drug treatment for PBC and studies have shown that up to 50% of PBC patients may have an inadequate response, thereby remaining at risk of adverse outcomes.

About Intercept

Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat orphan and more prevalent chronic liver and intestinal diseases utilizing its expertise in bile acid chemistry. The company’s lead product candidate, obeticholic acid (OCA), is a bile acid analog and first-in-class agonist of the farnesoid X receptor (FXR). OCA is being developed for a variety of chronic liver diseases including primary biliary cirrhosis (PBC), nonalcoholic steatohepatitis (NASH), and primary sclerosing cholangitis (PSC). OCA has received Fast Track Designation in the United States and orphan drug designation in both the United States and Europe for the treatment of PBC and PSC. Several large, randomized, controlled studies of OCA in the treatment of chronic liver disease have been completed. These include Intercept’s Phase 3 POISE trial for the treatment of patients with PBC and the NIDDK-sponsored FLINT trial for the treatment of patients with NASH. The detailed results of POISE were previously reported in April 2014 and the primary endpoint was based on the achievement of both a reduction in ALP level to below a threshold of 1.67 times ULN, with a minimum of 15% reduction in ALP level from baseline, and a normal bilirubin level. Intercept owns worldwide rights to OCA outside of Japan, China and Korea, where it has out-licensed the product candidate to Sumitomo Dainippon Pharma. For more information about Intercept, please visit the company’s website at: www.interceptpharma.com.

Safe Harbor Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the clinical relevance of the Global PBC Study Group data and the applicability thereof to OCA in PBC, the potential relationship between ALP and bilirubin and adverse clinical outcomes, the clinical utility of the POISE trial selected endpoints and any potential consensus relating thereto, clinical, preclinical and regulatory developments for our product candidates, the anticipated timetable for our clinical, regulatory and development activities, and our strategic directives under the caption “About Intercept.” These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of important risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the initiation, cost, timing, progress and results of our development activities, preclinical studies and clinical trials; the timing of and our ability to obtain and maintain regulatory approval of OCA and any other product candidates we may develop, particularly the possibility that regulatory authorities may require clinical outcomes data (and not just results based on achievement of a surrogate endpoint) as a condition to any marketing approval for OCA, and any related restrictions, limitations, and/or warnings in the label of any approved product candidates; our plans to research, develop and commercialize our product candidates; the election by our collaborators to pursue research, development and commercialization activities; our ability to attract collaborators with development, regulatory and commercialization expertise; our ability to obtain and maintain intellectual property protection for its product candidates; our ability to successfully commercialize our product candidates; the size and growth of the markets for our product candidates and our ability to serve those markets; the rate and degree of market acceptance of any future products; the success of competing drugs that are or become available; regulatory developments in the United States and other countries; the performance of third-party suppliers and manufacturers; our need for and ability to obtain additional financing; our estimates regarding expenses, future revenues and capital requirements and the accuracy thereof; our ability to retain key scientific or management personnel; and other factors discussed under the heading “Risk Factors” contained in our annual report on Form 10-K for the year ended December 31, 2013 filed on March 14, 2014 as well as any updates to these risk factors filed from time to time in our other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intercept undertakes no duty to update this information unless required by law.

CONTACT: For more information about Intercept Pharmaceuticals,
         please contact:

         Intercept Pharmaceuticals:
         Barbara Duncan or Senthil Sundaram
         +1-646-747-1000
         investors@interceptpharma.com

         Media inquiries:
         Chantal Beaudry or Christopher Frates
         Lazar Partners
         + 1-212-867-1762
         Intercept@lazarpartners.com
Friday, December 5th, 2014 Uncategorized Comments Off on (ICPT) Publication of Meta-Analysis From the Global PBC Study Group in Gastroenterology

(NMRX) Launches Enhanced Satellite Data Solution

Company Leads M2M Industry With New, Cost-Effective, Unlimited Satellite Data Plan

ATLANTA, Dec. 5, 2014 — Numerex (Nasdaq:NMRX), a leading provider of on-demand and interactive machine-to-machine (M2M) enterprise solutions enabling the Internet of Things (IoT), today announced that it has enhanced its service offering to provide an industry-leading unlimited satellite data plan specifically targeted for its suite of M2M products. This new service will be used to provide communications for M2M data collection and monitoring of customers’ assets that are deployed across the security, government, healthcare, energy and utilities, financial services, and transportation industries. In addition, the service plan includes mapping and analytic software and an API that can facilitate a data connection directly into a customer’s specific tracking application.

As M2M services move up the enterprise value chain, users prefer to monitor their assets more frequently throughout the day. Previous to this offering, satellite pricing levels for data transmission meant most companies limited their communications to just one or two messages per day. This resulted in GPS positioning data being received from far flung assets in the field only on an intermittent basis. With this new, economical, unlimited data plan, Numerex provides satellite tracking customers with a solution that allows them to more closely monitor their assets throughout each day, with updates transmitted as frequently as every five minutes.

“As an industry leading M2M Company offering an unlimited satellite data plan, Numerex continues to provide our customers with some of the most comprehensive and reliable satellite tracking options available in the market today,” said Scott Wiley, Senior Vice President of Marketing and Product Management. “The capability to acquire rich, near real-time transmissions from our M2M products allows our customers to respond quickly to the data flowing from their assets situated in virtually all regions of the world. The cost effectiveness of this solution opens up new possibilities and enables new value propositions for companies seeking high-frequency, near real time monitoring of widely dispersed assets located across town or across the globe.”

About Numerex

Numerex Corp. (Nasdaq:NMRX) is a leading provider of interactive and on-demand machine-to-machine (M2M) enterprise solutions enabling the Internet of Things (IoT). The Company provides its technology and services through its integrated M2M horizontal platforms, which are generally sold on a subscription basis. The Company offers Numerex DNA® solutions including hardware and smart Devices, cellular and satellite Network services, and software Applications utilizing Numerex solution technology. The Company also provides business services to enable the development of efficient, reliable, and secure solutions while accelerating deployment. Numerex is ISO 27001 information security-certified, highlighting the Company’s focus on M2M data security, service reliability and around-the-clock support of its customers’ M2M solutions. For additional information, please visit www.numerex.com.

Statements contained in this press release concerning Numerex that are not historical fact are “forward-looking” statements and involve important risks and uncertainties. Such risks and uncertainties, which are detailed in Numerex’s filings with the Securities and Exchange Commission, could cause Numerex’s results to differ materially from current expectations as expressed in this press release. These forward-looking statements speak only as of the date of this press release, and Numerex assumes no duty to update forward-looking statements.

© 2014 Numerex Corp. All rights reserved. Numerex, the Numerex logo and all other marks contained herein are trademarks of Numerex Corp. and/or Numerex-affiliated companies. All other marks contained herein are the property of their respective owners.

CONTACT: Numerex IR Contact:
         Seth Potter
         646-277-1230

         Media Contact:
         Valerie Christopherson
         Evan Sneider
         949-608-0276
         Numerex@globalresultspr.com
Friday, December 5th, 2014 Uncategorized Comments Off on (NMRX) Launches Enhanced Satellite Data Solution

(QURE) to Present at the Oppenheimer 25th Healthcare Conference – NYC

AMSTERDAM, The Netherlands, Dec. 5, 2014  — uniQure N.V. (Nasdaq: QURE), a leader in human gene therapy, today announced that its management will present at the Oppenheimer 25th Healthcare Conference – NYC, to be held December 10-11, 2014, at The Crowne Plaza Hotel in New York City, NY, USA.

Date:  December 11, 2014
Time:  9:45 a.m. (EST)
Location:  The Crowne Plaza Hotel, New York City, NY, USA
Speaking for uniQure:  Jörn Aldag, Chief Executive Officer

To access a simultaneous webcast of Mr. Aldag’s presentation via the internet, log on to the “Events” section on the Media page of the uniQure website at http://www.uniqure.com/news/calendar-of-events/.

A replay of the webcast will be available from uniQure’s website for 30 days following the conference. Mr. Aldag’s presentation will be available for download in PDF format immediately following the conference presentation in the “Events” section of the Media page of uniQure’s website at http://www.uniqure.com/news/calendar-of-events/.

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

uniQure:
Aicha Diba
Investor Relations
Direct : +31 20 240 6110
Main: +31 20 240 6000
a.diba@uniQure.com

Media inquiries:
Gretchen Schweitzer
MacDougall Biomedical Communications
Direct: +49 172 861 8540
Main: +49 89 2424 3494 or +1 781 235 3060
gschweitzer@macbiocom.com

Friday, December 5th, 2014 Uncategorized Comments Off on (QURE) to Present at the Oppenheimer 25th Healthcare Conference – NYC

(FRAN) Michael W. Barnes Named Chairman, President, and CEO

Company Announces Preliminary Fiscal Third Quarter Results; Expects Net Sales of Approximately $87 Million, Comparable Store Sales Decrease of 6%, and Diluted Earnings Per Share of $0.17

HOUSTON, Dec. 5, 2014  — Francesca’s Holdings Corporation (Nasdaq:FRAN) today announced that specialty retailing veteran Michael W. Barnes has been named Chairman, President, and Chief Executive Officer, effective immediately. He succeeds Neill Davis, who has resigned as President, CEO and a Director. Greg Brenneman, Chairman of the Board since 2010, has been named Lead Director.

Mr. Barnes joins francesca’s after serving as Chief Executive Officer of Signet Jewelers, Ltd. (NYSE:SIG) since 2011. He led Signet’s $1.46 billion acquisition of Zale Corp., which transformed Signet into the largest specialty jewelry retailer in the U.S., U.K. and Canada with approximately 3,500 retail outlets. Signet’s share price almost tripled during Mr. Barnes nearly four-year tenure. Prior to Signet, Mr. Barnes spent more than 25 years in increasingly senior roles at global consumer fashion accessory company Fossil Group, Inc., concluding in the role of President, Chief Operating Officer and a Director from 2007 to 2010. As one of Fossil’s first employees, he was part of the management team that took the Company public and led the rapid profitable growth of the business.

Mr. Brenneman said, “Mike Barnes is a world-class retail executive with a proven history of driving growth at specialty retailing businesses. His ability to set and execute transformational strategic plans, along with his track record of creating value for shareholders, make him the right executive to capitalize fully on francesca’s solid growth platform.  We are confident that he has the vision and skill set to make francesca’s one of America’s leading specialty retailers. We appreciate the contributions that Neill Davis made to francesca’s and we wish him well in his future endeavors.”

Mr. Barnes said, “I am honored by the Board’s confidence in me and look forward to building francesca’s by leveraging its outstanding brand, unique retailing strategy and deep customer loyalty. I am excited to lead a company with such tremendous potential and look forward to working with the strong leadership team and talented employees at francesca’s.”

francesca’s is announcing preliminary results for its fiscal third quarter ended November 1, 2014. Consistent with the lower end of its guidance, the Company expects net sales of approximately $87 million, a comparable sales decrease of 6%, and diluted earnings per share of $0.17.

As previously announced, francesca’s will report its third quarter results and provide its outlook for the fourth quarter on Wednesday, December 10, 2014, at 7:30 am ET. Mr. Barnes will join the conference call.

About Francesca’s Holdings Corporation:

francesca’s® is a growing specialty retailer with retail locations designed and merchandised to feel like independently owned, upscale boutiques providing customers a fun and differentiated shopping experience. The merchandise assortment is a diverse and balanced mix of apparel, jewelry, accessories and gifts. Today francesca’s® operates 538 boutiques in 47 states and the District of Columbia, and serves its customers through francescas.com. For additional information on francesca’s®, please visit www.francescas.com.

CONTACT: ICR, Inc.
         Jean Fontana
         646-277-1214

         Company
         Mark Vendetti
         832-494-2315
         mark.vendetti@francescas.com
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(BIRT) Signs Agreement to be Acquired by OpenText

Actuate Corporation (NASDAQ:BIRT), The BIRT Company™ and the leader in personalized analytics and insights, today announced that it has entered into an agreement to be acquired by OpenText. Under the terms of the merger agreement, an affiliate of OpenText will commence a tender offer to the Actuate stockholders to purchase any and all shares of common stock they hold for $6.60 in cash per share. The purchase price represents an approximately 89% premium to the closing price of Actuate common stock on December 4, 2014, and an equity value of approximately $330 million.

The addition of Actuate enables OpenText to enhance their products with embedded analytics as well as enter a growing market. Together Actuate and OpenText will seek to extend the benefits of embedded analytics to more geographies and industries. Industry research indicates embedded analytics is increasing in its importance. Embedded analytics turns information into intelligence by providing users with relevant, actionable insights delivered within the context of the application. This adds substantial value for companies embedding analytics into applications to help drive better customer engagement and improved decision making.

The Board of Directors of Actuate has unanimously approved the transaction. The transaction is expected to close in the first quarter of 2015, subject to Actuate stockholders tendering a majority of Actuate’s outstanding shares pursuant to the tender offer and other customary closing conditions, including regulatory approvals.

“Actuate has been focused on delivering value of information for over 20 years. We believe this agreement will enhance the OpenText product line through embedded analytics and open a new growth market for OpenText,” said Pete Cittadini, president and CEO of Actuate.

For further information regarding all terms and conditions contained in the definitive merger agreement, please see Actuate’s Current Report on Form 8-K, which will be filed in connection with this transaction.

About Actuate (NASDAQ:BIRT) – The BIRT Company™

Actuate provides software to more than 3.5 million BIRT developers and OEMs who build scalable, secure solutions that save time and improve brand experience by delivering personalized analytics and insights to over 200 million of their customers, partners and employees. Actuate founded and supports BIRT – the open source IDE – and develops BIRT iHub™ – the world-class visualization and deployment platform – to significantly improve productivity of developers working on customer facing applications. Actuate’s BIRT Analytics™ delivers self-service predictive analytics to enhance customer engagement using Big Data. The Actuate Customer Communications Suite™ empowers organizations to easily transform, process, personalize, archive and deliver high volume content and individualized correspondence. Actuate is headquartered in Silicon Valley with more than 5,000 enterprise customers in financial services, technology and government. Visit actuate.com and developer.actuate.com.

Additional Information and Where to Find It

This document does not constitute an offer to buy or a solicitation of an offer to sell securities. The tender offer for the outstanding shares of common stock of Actuate (“Offer”) described in this document has not commenced. At the time the Offer is commenced, OpenText Corporation (“OpenText”) and Asteroid Acquisition Corporation, a wholly‐owned subsidiary of OpenText (the “Merger Subsidiary”) will file a Tender Offer Statement on Schedule TO with the U.S. Securities and Exchange Commission (“SEC”), and Actuate will file a Solicitation/Recommendation Statement on Schedule 14D‐9 with the SEC. The Tender Offer Statement (including an offer to purchase, a related letter of transmittal and other offer documents) and the Solicitation/Recommendation Statement, as they may be amended from time to time, will contain important information that should be read carefully before any decision is made with respect to the Offer. Those materials and all other documents filed by Actuate, OpenText or Merger Subsidiary with the SEC will be available both at no charge on the SEC’s web site at www.sec.gov and may be obtained for free by directing requests to ir@actuate.com.

Cautionary Statement Regarding Forward‐Looking Statements

This document contains forward‐looking statements that involve risks and uncertainties concerning the parties’ ability to close the transaction and the expected closing date of the transaction, and reflect management’s best judgment based on factors currently known. Our actual results may differ materially from those discussed here. These risks and uncertainties include, among others: the timing of the closing of the proposed transaction, the outcome of regulatory reviews of the proposed transaction, the ability of the parties to complete the transaction, the ability of the parties to meet the closing conditions and other risks detailed from time to time in our SEC filings, including our most recent annual report on Form 10‐K and most recent quarterly report on Form 10‐Q. We disclaim any intention or obligation to publicly update or revise any forward‐looking statements, including any guidance, whether as a result of events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Copyright © 2014 Actuate Corporation. All rights reserved. Actuate, legodo, BIRT iHub, BIRT iHub F-Type, BIRT Analytics, Actuate Customer Communications Suite, The Actuate Document Accessibility Appliance, BIRT PowerDocs, BIRT onDemand, BIRT Viewer Toolkit, and the Actuate logo are trademarks or registered trademarks of Actuate Corporation and/or its affiliates in the U.S. and certain other countries. The use of the word “partner” or “partnership” does not imply a legal partnership relationship between Actuate and any other company. All other brands, names or trademarks mentioned may be trademarks of their respective owners.

 

Market Street Partners
Jacob Moelter, +1-415-445-3235
ir@actuate.com
or
Actuate
Samantha Singh,+1-650-645-3078
Corporate Communications
ssingh@actuate.com

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(OVAS) to Present at the Oppenheimer Healthcare Conference

OvaScienceSM (NASDAQ:OVAS), a global life sciences company focused on the discovery, development and commercialization of new fertility treatments, announced today that Company management will present at the Oppenheimer 25th Annual Healthcare Conference on Thursday, December 11, 2014 at 2:10 pm ET at the Crowne Plaza Times Square hotel in New York.

A live audio webcast of the presentation can be accessed by visiting the Investors section of the Company’s website at www.ovascience.com. A replay of the webcast will be archived on the OvaScience website for two weeks following the presentation.

About OvaScience

OvaScience (NASDAQ:OVAS) is a global life sciences company dedicated to improving fertility for women around the world. OvaScience is discovering, developing and commercializing new fertility treatments because we believe women deserve more options. Each OvaScience treatment is based on the Company’s proprietary technology platform that leverages the breakthrough discovery of egg precursor (EggPCSM) cells – immature egg cells found inside the protective ovarian lining. The AUGMENTSM treatment, a fertility option specifically designed to improve egg health, is available in certain IVF clinics in select international regions outside of the United States. OvaScience is developing the OvaPrimeSM treatment, which could expand a woman’s egg reserve, and the OvaTureSM treatment, a potential next-generation IVF treatment that could help a woman produce healthy, young, fertilizable eggs without hormone injections. For more information, please visit www.ovascience.com and connect with us on Twitter and Facebook.

Forward-Looking Statements

This press release includes forward-looking statements about the Company’s plans for the AUGMENT treatment and its two fertility treatments in development. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: the possibility that international IVF clinics that we work with may determine not to begin or continue providing the AUGMENT treatment for commercial or other reasons; our expectation that the AUGMENT treatment and OvaPrime treatment meet the requirements of a class of products exempt from premarket review and approval under applicable regulations in those countries where we have launched or plan to introduce the AUGMENT treatment and plan to introduce the OvaPrime treatment; the science underlying our treatment and treatments in development (including the AUGMENT, OvaPrime and OvaTure treatments), which is unproven; our ability to obtain regulatory approval where necessary for our potential treatments; our ability to develop our potential treatments, including the OvaPrime and OvaTure treatments, on the timelines we expect, if at all; our ability to commercialize the AUGMENT treatment and our potential treatments, including the OvaPrime treatment, on the timelines we expect, if at all; as well as those risks more fully discussed in the “Risk Factors” section of our most recently filed Quarterly Report on Form 10-Q and/or Annual Report on Form 10-K. The forward-looking statements contained in this press release reflect our current views with respect to future events. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our view as of any date subsequent to the date hereof.

OvaScience:
Cara Petralia, 617-714-9638
Director, Corporate Communications
cpetralia@ovascience.com

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(TUBE) Launches PTV, Enabling Programmatic Buying of TV Advertising

The first self-serve software for automated buying of TV ads spans over 80 cable networks and hundreds of local broadcasters, reaching over 90% of American households

NEW YORK, Dec. 4, 2014  — Today, TubeMogul (NASDAQ: TUBE) premiered TubeMogul PTV, a software solution that enables automated, data-driven buying of TV advertising. The product was unveiled at The TimesCenter, with over 250 brands and advertising agencies attending.

Over 10 brands and ad agencies have already signed up for TubeMogul PTV, including 3M, Allstate, Digitas and Levelwing (who will be executing buys on behalf of Gildan USA).

TubeMogul PTV aggregates TV advertising inventory from the major cable and satellite companies, national TV networks and local broadcasters. This is made possible by integrations with the leading TV supply side platforms, including AudienceXpress, clypd and placemedia. At launch, TubeMogul will also be the exclusive buy-side technology partner for WideOrbit, whose WO Programmatic– TV marketplace helps 75% of local TV stations automate their ad sales.

Historically, the planning and buying of TV ads has been a time-consuming, manual process that offered little room for optimization. Targeting is generally limited to age and gender, and navigating the complexities of the upfronts, scatter and disparate regional markets is difficult.

TubeMogul PTV changes that, making every TV ad more valuable and efficient for brand marketers. TubeMogul’s buying software is the first to enable advertisers to target specific TV networks and dayparts. To inform these targets, TubeMogul incorporates data from Nielsen and others, recommending media mixes that index highly toward specific audiences. Targeting is available by: age, gender, income level, ethnicity, educational level, children in household, home ownership status, automobile preferences, pet ownership and more.

As a campaign proceeds, marketers can utilize granular measurement to inform optimization and strategy. Third-party verification and analytics are built into the software, allowing for deeper analysis of shows, dayparts and regions. Instead of adjusting strategy in weeks or months, advertisers can shift spending in real-time based on their goals.

“TubeMogul PTV brings the accountability and control of programmatic buying to TV for the first time,” said Brett Wilson, CEO and Co-Founder of TubeMogul. “By automating TV buys, marketers can focus on strategy and better results for their clients.”

“3M has long been synonymous with innovation and invention, and TubeMogul PTV helps us make sure that our advertising strategy reflects those values,” said Chris Luna, Digital Media Specialist at 3M. “By buying TV through software, we can bring more relevant messages to potential customers.”

“All of our clients need to be able to reach their target audience as media consumption shifts between screens,” said Steve Parker Jr, CEO & Co-Founder at Levelwing. “Today we can use a single piece of software to ensure that we’re improving relevance and resonance among viewers, ultimately improving ROI.”

About TubeMogul
TubeMogul is an enterprise software company for digital branding. By reducing complexity, improving transparency and leveraging real-time data, our platform enables advertisers to gain greater control of their video advertising spend and achieve their brand advertising objectives. TubeMogul was incorporated in 2007 and is based in Emeryville, California with operations in New York, London, Singapore, Tokyo, Sydney, Toronto and offices across the United States.

Press Contact:
David Burch
press@tubemogul.com
1 (510) 653-0501

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(CLRB) Granted Orphan Designation for I-131-CLR1404 for the Treatment of Multiple Myeloma

MADISON, Wis., Dec. 4, 2014  — Cellectar Biosciences, Inc. (Nasdaq:CLRB), a clinical stage biopharmaceutical company developing innovative agents for the detection and treatment of cancer, announced that the U.S. Food and Drug Administration (FDA) has granted Cellectar’s request for orphan drug designation of I-131-CLR1404 for the treatment of multiple myeloma, an incurable cancer of plasma cells.

“We are thrilled that I-131-CLR1404 has been designated an orphan drug for the treatment of multiple myeloma,” commented Dr. Natalie Callander, principal investigator of Cellectar’s I-131-CLR1404 multiple myeloma trial, Associate Professor of Medicine, and Director, University of Wisconsin Carbone Cancer Center Myeloma Clinical Program. “Despite advances in the last several decades, multiple myeloma remains an incurable malignancy and agents with new and unique mechanisms of action, such as I-131-CLR1404, are essential to improving outcomes and survival. This designation reflects both the FDA’s and Cellectar’s important focus on addressing the unmet clinical needs of patients with diseases such as multiple myeloma.”

The Orphan Drug Act provides for economic incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the United States. Orphan drug designation will entitle Cellectar to seven years of market exclusivity for I-131-CLR1404 as a treatment for relapsed or refractory multiple myeloma following marketing approval by the FDA. Additional benefits include tax credits related to clinical trial expenses, a possible exemption from the FDA-user fee, assistance in clinical trial protocol design, and fewer patients required for new drug applications.

“This orphan designation is a critical milestone in our program and will support our efforts to move I-131-CLR1404 as quickly as possible through the clinical and regulatory development process,” said Dr. Simon Pedder, president and chief executive officer of Cellectar Biosciences. “We are in the final stages of preparing our clinical sites to initiate a proof-of-concept trial of I-131-CLR1404 in multiple myeloma and look forward to working with Dr. Callander to evaluate I-131-CLR1404 as a targeted therapeutic in this indication.”

About Multiple Myeloma

Multiple myeloma is a form of blood cancer that primarily affects older adults and arises from plasma cells in the bone marrow. According to the National Cancer Institute, multiple myeloma is the second most common blood cancer in the United States and constitutes approximately 1 percent of all cancers. The National Cancer Institute estimates that 24,500 Americans will be diagnosed with multiple myeloma in 2014 and 11,090 will die from the disease.

About I-131-CLR1404

I-131-CLR1404 is a small-molecule, broad-spectrum, cancer-targeted radiopharmaceutical comprised of a proprietary optimized phospholipid ether (PLE) analog, acting as a cancer-targeted delivery and retention vehicle, covalently labeled with iodine-131, a cytotoxic radioisotope that is already commonly used to treat thyroid and other cancer types. I-131-CLR1404 is engineered to combine an intracellular radiation mechanism of cancer cell killing with targeted delivery to a wide range of malignant tumor types. Preclinical models have also demonstrated selective uptake and retention in cancer stem cells, suggesting the potential for longer lasting cancer remission.

About Cellectar Biosciences, Inc.

Cellectar Biosciences is developing agents to detect, treat and monitor a broad spectrum of cancers. Using a novel phospholipid ether analog (PLE) platform technology as a targeted delivery and retention vehicle, Cellectar’s compounds are designed to be selectively taken up and retained in cancer cells including cancer stem cells. With the ability to attach both imaging and therapeutic agents to its proprietary delivery platform, Cellectar has developed a portfolio of product candidates engineered to leverage the unique characteristics of cancer cells to “find, treat and follow” malignancies in a highly selective way. I-124-CLR1404 is a small-molecule, broad-spectrum, cancer-targeted PET imaging agent currently being evaluated in a Phase II glioblastoma imaging trial. Additionally, multiple investigator-sponsored Phase I/II clinical trials are ongoing across 11 solid tumor indications. I-131-CLR1404 is a small-molecule, broad-spectrum, cancer-targeted molecular radiotherapeutic that delivers cytotoxic radiation directly and selectively to cancer cells including cancer stem cells. A Phase Ib dose-escalation trial of I-131-CLR1404 in patients with advanced solid tumors was completed in the first quarter of 2014 and results presented at the American Society of Clinical Oncology (ASCO) 2014 Annual Meeting. CLR1502 is a preclinical, cancer-targeted, non-radioactive optical imaging agent for intraoperative tumor margin illumination and non-invasive tumor imaging. For additional information please visit www.cellectar.com

This news release contains forward-looking statements. You can identify these statements by our use of words such as “may,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” “continue,” “plans,” or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators’ ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2013. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

CONTACT: INVESTOR CONTACT

         Kate McNeil, Vice President of IR, PR & Corporate Communications
         Cellectar Biosciences, Inc.
         Phone: (347) 204-4226
         Email: kmcneil@cellectar.com
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(TLOG) Clinical Data on Birinapant To Debut At 56th Annual American Society of Hematology

MALVERN, Pa., Dec. 4, 2014  — TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG) today announced that two abstracts related to clinical data on birinapant will be presented at the 56th Annual American Society of Hematology meeting to be held in San Francisco from December 6-9, 2014.

The date and time of the poster presentations are as follows:

Date & Time: Sunday, December 7, 2014; 6:00p.m.-8:00p.m.
Session: 637. Myelodysplastic Syndromes-Clinical Studies: Poster II
Presentation Title: A Phase 1b/2a Study of Birinapant in Combination with 5-Azacitadine in Patients with Myelodysplastic Syndrome Who Are Naïve, Refractory to or Have Relapsed on 5-Azacitadine: a Preliminary Analysis
Abstract #: 3263
Location: West Building, Level 1 (Moscone Center)
Date & Time: Monday, December 8, 2014; 6:00p.m.-8:00p.m.
Session: 616. Acute Myeloid Leukemia; Novel Therapy, excluding Transplantation: Poster III
Presentation Title: A Phase I Study Using Single Agent Birinapant in Patients with Relapsed Myelodysplastic Syndrome and Acute Myelogenous Leukemia
Abstract #: 3758
Location: North Building, Hall E (Moscone Center)

About TetraLogic Pharmaceuticals Corporation

TetraLogic is a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics in oncology and infectious diseases. TetraLogic has two clinical-stage product candidates in development: birinapant and SHAPE. Birinapant is currently being tested in Phase 1 and Phase 2 clinical trials for hematological malignancies and solid tumors, and is also being tested in a Phase 1b/2a clinical trial in hepatitis B. SHAPE is entering a Phase 2 clinical trial for early-stage Cutaneous T-cell Lymphoma.

Forward Looking Statements

Some of the statements in this release are forward looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events or TetraLogic’s pre-clinical and clinical development of birinapant, SHAPE and other clinical programs, future expectations, plans and prospects. Although TetraLogic believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. TetraLogic has attempted to identify forward looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under the heading “Risk Factors” in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 19, 2014 and in our form 10-Q filed with the SEC on November 5, 2014. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

CONTACT: Company Contact:
         Pete A. Meyers
         Chief Financial Officer and Treasurer
         TetraLogic Pharmaceuticals Corporation
         (610) 889-9900, x103
         pete.meyers@tlog.com

         Investor Relations Contact:
         Ami Bavishi
         Burns McClellan, Inc.
         (212) 213-0006
         abavishi@burnsmc.com
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(ALSK) GCI to Purchase Wireless Subscriber Base from Alaska Communications

Alaska Communications System Group, Inc. (NASDAQ:ALSK) and General Communication, Inc. (GCI) (NASDAQ:GNCMA) have signed definitive agreements for Alaska Communications to sell its wireless subscriber base and its 33 percent interest in its partnership in the Alaska Wireless Network, LLC (AWN) to GCI for $300 million.

Under the terms of the agreements and upon close:

  • GCI will assume Alaska Communications’ wireless subscriber base. Services will be uninterrupted and will continue to operate statewide and nationally.
    • As of September 30, 2014, Alaska Communications had approximately 109,000 wireless customers.
  • GCI will purchase Alaska Communications’ 33 percent interest in AWN and will then own 100 percent of AWN. Upon close, these agreements will eliminate future preferred and partnership distributions that otherwise would have been due under the original AWN agreements. Up until close Alaska Communications will continue to receive preferred distributions from AWN.
  • The two companies have agreed upon a service transition plan for Alaska Communications customers. This will ensure a seamless continuation of service as they are transitioned to GCI.
  • Alaska Communications wireless customers will continue to enjoy service on Alaska’s only statewide network.
  • The transaction is targeted to close in the first quarter, 2015, and is subject to certain closing conditions.

“We are pleased to reach these agreements that allow each company to pursue its own strategy,” said Alaska Communications President and CEO Anand Vadapalli and GCI President and CEO Ron Duncan in a joint statement. “We are committed to a seamless service transition for wireless customers. Alaskans will continue to benefit from a vibrant competitive market for wireless services.”

Vadapalli added, “We appreciate the loyal support of our wireless customers and thank our wireless team who consistently deliver excellent customer service. We will continue to provide customers with this same level of quality service and support during the transition of wireless services.”

Duncan concluded, “We welcome wireless subscribers from Alaska Communications and are committed to providing them the latest technologies and superior customer service on Alaska’s only statewide network.”

GCI and Alaska Communications will notify customers with further details regarding this transition and customers do not need to take any action at this time.

About the Alaska Wireless Network (AWN)

AWN was formed in July 2013 and combined the wireless network assets of Alaska Communications and GCI. The transaction was designed to position the two companies to better compete against national wireless carriers. Under terms of the agreement, GCI retained two-thirds ownership and Alaska Communications retained one-third ownership.

About Alaska Communications

Alaska Communications (NASDAQ: ALSK) is a leading provider of advanced broadband and managed service solutions for businesses and consumers in Alaska. The Company operates a highly reliable, advanced statewide data and voice network with the latest technology and the most diverse undersea fiber optic system connecting Alaska to the contiguous United States. For more information, visit www.alaskacommunications.com or www.alsk.com.

About GCI

GCI is the largest Alaska-based and -operated, integrated telecommunications provider, offering wireless, voice, data, and video services statewide. Learn more about GCI at www.gci.com.

Forward-Looking Statements

This joint release includes certain “forward-looking statements,” as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s beliefs as well as on a number of assumptions concerning future events made using information currently available to management. Readers are cautioned not to put undue reliance on such forward-looking statements, which are not a guarantee of performance and are subject to a number of uncertainties and other factors, many of which are outside GCI’s or Alaska Communications’ control. For further information regarding risks and uncertainties associated with either company’s business, please refer to either GCI’s or Alaska Communications’ SEC filings.

Alaska Communications Contacts:
Media:
Heather Cavanaugh, 907-564-7722
Director, Corporate Communications
Heather.Cavanaugh@acsalaska.com
or
Investor Relations:
Tiffany Dunn, 907-564-7556
Manager, Board and Investor Relations
acsinvestors@acsalaska.com
or
GCI Contacts:
Media:
David Morris, 907-265-5396
VP, Corporate Communications
dmorris@gci.com
or
Investor Relations:
Tom Chesterman, 907-868-1585
VP, Finance
investor@gci.com

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(RADA) Leading MOD Selects RADA’s Tactical Radars for Its National Alert System

RADA’s Tactical Radar Systems Provide Volume Surveillance and Detection of Multiple Threat Types, Including UAVs, Mortars, and Rockets

NETANYA, Israel, Dec. 4, 2014  — RADA Electronic Industries Ltd. (Nasdaq:RADA) announces the selection of its MHR-based tactical radars by a leading MOD of for its national alert system. The radars will detect and alert from short-range threats such as mortars, rockets, UAVs and alike.

Deliveries are expected to be completed during 2015.

The MHR – an S-Band, Software-Defined, Pulse-Doppler, AESA radar – has sophisticated beam forming capabilities and advanced signal processing, provides multiple missions on each radar platform, and offers unprecedented performance-to-price ratio. It is compact and mobile, delivering ideal organic, tactical surveillance solutions for force and border protection applications such as C-UAS, C-RAM, GMTI, air surveillance, and more.

According to Zvi Alon, RADA’s CEO, “We are extremely proud with this competitive selection of our technology. This is a major award of a radar program for RADA, which joins other strategic awards for radar programs during 2014. We believe that additional leading countries and integrators will follow this selection.”

About RADA

RADA Electronic Industries Ltd. is an Israel-based defense electronics contractor. The Company specializes in the development, production, and sale of Tactical Land Radars for Force and Border Protection, Inertial Navigation Systems for air and land applications, and Avionics Systems and Upgrades.

CONTACT: RADA
         Dubi Sella (CBDO)
         Tel: +972-9-892-1111
         mrkt@rada.com
         www.rada.com
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(OTIV) Announces Pricing of Public Offering of Ordinary Shares

ROSH PINA, ISRAEL–(Nov 21, 2014) – On Track Innovations Ltd (oti) (NASDAQ: OTIV) today announced that it has priced an underwritten public offering of 6,250,000 ordinary shares at a price of $1.60 per ordinary share for aggregate gross proceeds of $10 million. oti expects net proceeds, after underwriting discounts and commissions and estimated offering expenses payable by oti, of approximately $9.1 million. oti has also granted to the underwriter a 30-day option to purchase up to an additional 937,500 of its ordinary shares to cover over-allotments, if any. The offering is expected to close on or about November 26, 2014, subject to satisfaction of customary closing conditions. Northland Capital Markets is acting as the sole underwriter for the offering.

The ordinary shares are being offered pursuant to a registration statement on Form S-3 (File No. 333-199180) filed pursuant to the Securities Act of 1933, as amended, which was previously filed with, and declared effective by, the Securities and Exchange Commission (SEC). A preliminary prospectus supplement relating to the offering has also been filed with the SEC.

A final prospectus supplement and an accompanying prospectus will be filed with the SEC in connection with the offering. These documents, as filed with the SEC, may be obtained by sending a request to Northland Securities, Inc. at 45 South 7th Street, Suite 2000, Minneapolis, MN 55402, via telephone toll free at (800) 851-2920 or via email to gturgeon@northlandcapitalmarkets.com. Before you invest, you should read these documents and the other documents that the company has filed with the SEC for more complete information about the company and this offering. Investors may obtain these documents for free by visiting the SEC’s website at www.sec.gov.

Northland Capital Markets is the trade name for certain capital markets and investment banking services of Northland Securities, Inc., member FINRA/SIPC.

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

About oti

On Track Innovations Ltd. (oti) is a leader in contactless and near field communications (NFC) applications based on its extensive patent and IP portfolio. oti’s field-proven innovations have been deployed around the world to address NFC and other cashless payment solutions, petroleum payment and management, cashless parking fee collection systems and mass transit ticketing. oti markets and supports its solutions through a global network of regional offices and alliances. For more information, visit www.otiglobal.com, the content of which is not a part of this press release.

Safe Harbor Statement

This press release contains certain forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any such statements, including, but not limited to, oti’s expectations regarding the completion, timing and size of its proposed public offering, including exercise of the over-allotment option, if any, whether expressed or implied, are subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed offering, and other risk factors discussed in the Company’s preliminary prospectus supplement, prospectus supplement, Annual Report on Form 10-K for the year ended December 31, 2013 and other documents filed with the SEC from time to time. These forward-looking statements represent oti’s judgment as of the date of this press release. Except as legally required, oti disclaims any intent or obligation to update these forward-looking statements.

Investor Contact:
Scott Liolios or Matt Glover
Liolios Group, Inc.
949-574-3860
Email Contact

Press Contact:
Inbar Ben-Hur
oti Marketing Communication Manager
Email Contact

Wednesday, December 3rd, 2014 Uncategorized Comments Off on (OTIV) Announces Pricing of Public Offering of Ordinary Shares

(MPET) Announces Potential Acquisition of CO2 Source and Poplar Pilot Update

DENVER, CO–(December 03, 2014) – Magellan Petroleum Corporation (NASDAQ: MPET) (“Magellan” or the “Company”) today announced that it has, through an affiliated entity, acquired an option to acquire a large CO2 reservoir called Farnham Dome located in Carbon County, Utah.  Pursuant to the agreement, the seller, Savoy Energy, LLC, has granted Magellan the right to either purchase the field outright or purchase uncontracted CO2 at a fixed price.  The option will expire on March 31, 2015, unless extended.

J. Thomas Wilson, President and CEO of Magellan, commented: “Since beginning the CO2-enhanced recovery (“CO2-EOR”) pilot project at Poplar Dome, Magellan has made a strategic decision to focus the company on EOR opportunities in North America. The utilization of CO2 to increase recovery of oil from existing reservoirs in the Rocky Mountains will be our top priority. Pursuant to that decision, Magellan is seeking to identify both attractive candidates for CO2-EOR projects and a reliable, low-cost supply of CO2. The acquisition of Farnham Dome CO2 would address the latter while the Company actively evaluates opportunities to utilize this CO2 to substantially increase its reserves at attractive costs. Over the last 18 months the Company has developed considerable expertise in utilizing CO2 to enhance recovery from older fields with large volumes of original oil in place. We believe the experience we are gaining at Poplar Dome can be applied to other fields that we are currently evaluating in the vicinity of Farnham Dome. The successful acquisition of applicable properties in combination with a long-term, low-cost source of CO2 will result in profitable projects at current oil prices or even below. It is our belief that the well managed low cost CO2 projects compete well with even the better unconventional plays.”

Poplar CO2-EOR Pilot Update

Since August 2014, the Company has been injecting CO2 into the B-2 zone of the Charles formation at Poplar. The resulting downhole pressure has remained stable and above the minimum pressure necessary for the CO2 and oil to be miscible. The expanding CO2 front should aid in the recovery of additional oil volumes and help meet the desired projections for the pilot project.

In early October 2014, Magellan opened the four pilot producer wells. The Company expects to see increased oil production from these wells by the first quarter of 2015 and to be able to quantify additional recoverable oil from the B-2 zone on a full field basis by June 2015.

Based on the results to date, Magellan anticipates that the CO2 will efficiently “sweep” the oil in place to the producer well bores and demonstrate the economic potential of CO2-EOR at Poplar. If successful, efforts in the B-2 interval will be followed rapidly by a pilot in the B-1 zone with other potential pay targeted for the future.

CAUTIONARY INFORMATION ABOUT FORWARD-LOOKING STATEMENTS
Statements in this press release, including forecasts or projections that are not historical in nature, are intended to be, and are hereby identified as, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “assume”, “believe”, “budget”, “estimate”, “evaluate”, “expect”, “forecast”, “intend”, “should”, “initial”, “plan”, “project”, and similar expressions are intended to identify forward-looking statements. These statements about the Company may relate to its businesses and prospects, planned capital projects and expenditures, increases or decreases in oil and gas production and reserves, estimates regarding recoverable resource potential, revenues, expenses and operating cash flows, progress in developing the Company’s projects, future values of those projects and other matters that involve a number of uncertainties that may cause actual results to differ materially from expectations. Among these risks and uncertainties are the following: potential inaccuracy in estimates of recoverable resources and/or the value of such resources; possible adverse changes to the CO2-EOR industry, possible geologic or other obstacles to the further development of the Company’s Poplar project and other exploration and development efforts, including uncertainties about the technical and economic viability of CO2-EOR techniques; possible geologic or other obstacles to obtaining the anticipated production from the Company’s projects and the timing of development milestones; and other matters discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10K. Any forward-looking information provided in this release should be considered with these factors in mind. The Company assumes no obligation to update any forward-looking statements contained in this press release, whether as a result of new information, future events, or otherwise, except as required by securities law.

ABOUT MAGELLAN
Magellan Petroleum Corporation is an independent oil and gas exploration and production company focused on the development of a CO2-enhanced oil recovery (“CO2-EOR”) program at Poplar Dome in eastern Montana and the exploration of hydrocarbon resources in the Weald Basin, onshore UK. Magellan also owns an exploration block, NT/P82, in the Bonaparte Basin, offshore Northern Territory, which the Company currently plans to farm-out; and an 11% ownership stake in Central Petroleum Limited, a Brisbane based junior exploration and production company that operates one of the largest holdings of prospective onshore acreage in Australia. Magellan is headquartered in Denver, Colorado. The Company’s mission is to enhance shareholder value by maximizing the full potential of existing assets. Magellan routinely posts important information about the Company on its website at www.magellanpetroleum.com.

For further information, please contact:
Matthew Ciardiello
Vice President
CFO, Treasurer, and Corporate Secretary
720.484.2404
IR@magellanpetroleum.com

Wednesday, December 3rd, 2014 Uncategorized Comments Off on (MPET) Announces Potential Acquisition of CO2 Source and Poplar Pilot Update

(ORMP) Closes $5 Million Investment From Guangxi Wuzhou Pharmaceutical Company

JERUSALEM, Israel, December 3, 2014 —

Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP), a developer of oral drug delivery systems, today announced that it has received $5 million in connection with the definitive agreement with Guangxi Wuzhou Pharmaceutical Co., Ltd., a subsidiary of Guangxi Wuzhou Zhongheng Group Company Ltd (SHA:600252) previously reported on November 3, 2014, for the purchase of 696,378 restricted shares of common stock for $7.18 per share, the closing price of Oramed’s common stock on Friday, October 31, 2014, in a private placement.

Guangxi Wuzhou Zhongheng Group Company Ltd is an investment holding company publicly traded on the Shanghai Stock Exchange.

“We are pleased to have Wuzhou as a new shareholder,” noted Nadav Kidron, Chief Executive Officer of Oramed. “China offers a substantial market opportunity for our diabetes focused pipeline and we are delighted to have Wuzhou as a supportive shareholder, as they can help strategically guide our development and commercial entrance into China,” commented CEO Nadav Kidron.

Oramed intends to use the net proceeds from this offering for expenses primarily related to the Company’s anticipated U.S. focused clinical development programs for its oral insulin for type 1 and type 2 diabetes indications, for preclinical and clinical studies of its oral GLP-1 analog project, and for general corporate purposes, including general working capital purposes.

This press release is neither an offer to sell nor a solicitation of an offer to buy any of the Company’s securities. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.

About Oramed Pharmaceuticals

Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (POD™) technology is based on over 30 years of research by top scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801). Having completed separate Phase IIa clinical trials, the company anticipates the initiation of separate Phase IIb clinical trials, in patients with both type 1 and type 2 diabetes under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition the company is developing an oral GLP-1 analog capsule (ORMD-0901).

For more information, the content of which is not part of this press release, please visit  http://www.oramed.com

Forward-looking statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, we are using forward-looking statements when we discuss our clinical trials, including the expected timing thereof, and revolutionizing the treatment of diabetes with our products. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and final that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed’s reports filed from time to time with the Securities and Exchange Commission.

Company Contact
Oramed Pharmaceuticals
Ariella Nachman
Office: +972-2-566-0001 ext. 2
US: +1-718-831-2512 ext. 2
Email: ariella@oramed.com

Wednesday, December 3rd, 2014 Uncategorized Comments Off on (ORMP) Closes $5 Million Investment From Guangxi Wuzhou Pharmaceutical Company

(ALCO) Announces Three Strategic Acquisitions

Combined Entity Will Be the Largest Citrus Producer in the U.S.

FORT MYERS, Fla., Dec. 3, 2014  — Alico, Inc. (NASDAQ: ALCO, “Alico” or “the company”), an agriculture and natural resources company, today announced the acquisition of three Florida citrus producers for total consideration of approximately $363 million. These acquisitions will make Alico’s citrus division the largest citrus producer in the United States, with total pro forma 2014 production of 10 million boxes annually.

The acquisitions, based on 2014 performance, would have increased Alico’s Adjusted EBITDA from $21 million on a standalone basis to approximately $58 million on a pro forma basis, excluding the impact of anticipated synergies, which, when fully phased in, are expected to add approximately $5 million of incremental EBITDA annually. Similarly, the transactions would have increased Alico’s 2014 Adjusted Earnings per Share and Adjusted Free Cash Flow per Share from $1.00 and $0.96 on a standalone basis to approximately $2.77 and $3.31, respectively, on a pro forma basis, excluding anticipated synergies and one-time items.

“These transactions are transformative for our citrus business and represent a major step forward in our strategy to become a leading agriculture and natural resources company by identifying and executing on accretive growth opportunities,” said Clay Wilson, Chief Executive Officer of Alico. “We intend to continue to target attractive markets and establish leading positions in our different business lines where scale and expertise can generate strong returns for our investors.”

“With the support of our Board of Directors, we have taken these actions to meaningfully enhance our position in the citrus industry. We have done this by maintaining our focus on the return characteristics of each of our assets and, where appropriate, redeploying capital to seek higher returns,” said Hank Slack, Chairman of Alico’s Board of Directors. “We believe that what we have done in the citrus space can be replicated across our other business lines to further strengthen and grow the Alico franchise.”

The three acquisitions are: (1) certain assets and liabilities of Orange-Co, LP, (2) 734 Citrus Holdings, LLC, also known as Silver Nip Citrus, and (3) Gator Grove.

The Orange-Co assets include approximately 20,263 acres, which comprises one of the largest contiguous citrus grove properties in the state of Florida. The $274 million Orange-Co acquisition was financed with proceeds from Alico’s recently announced $97 million sale of its sugarcane assets and a portion of the proceeds from Alico’s new long-term debt facilities and related credit lines. The Orange-Co acquisition closed on December 2, 2014.

Silver Nip Citrus is comprised of approximately 7,434 acres. The $72 million Silver Nip Citrus acquisition will be financed with the rollover of its existing credit facilities totaling $43 million and the issuance of approximately 0.8 million shares of Alico common stock. The Silver Nip Citrus acquisition is expected to close in the first quarter of 2015. The closing of the Silver Nip Citrus acquisition is subject to the satisfaction and waiver of other customary conditions. 734 Investors, LLC, Alico’s majority shareholder, will seek the consent of a majority of its disinterested members to direct 734 Investors to approve the issuance of Alico common stock in the acquisition by written consent of its Alico shares. In connection with the Silver Nip Citrus acquisition, the company anticipates issuing additional shares of Alico common stock to the sellers at the end of the 2014/2015 citrus harvest season based on the net proceeds received from the sale of citrus fruit harvested on certain Silver Nip Citrus groves.

Gator Grove is comprised of approximately 1,241 acres contiguous to the Orange-Co property. The $16.6 million Gator Grove acquisition was financed with cash on hand and closed on September 23, 2014.

Pro forma for the closing of the transactions, net debt is expected to be approximately $232 million with a weighted average cost of 3.6 percent (based on current interest rates), and the company will have approximately 8.2 million fully diluted shares outstanding.

Transaction Highlights

Management believes that the acquisitions will yield significant benefits for the company and its shareholders, including:

Creates the largest citrus producer in the U.S. Pro forma for the transactions announced today, Alico’s citrus division will be the largest citrus producer in the U.S. The acquisitions increase the citrus division’s total net grove acres from approximately 10,900 acres on a standalone basis to approximately 32,600 acres on a pro forma basis (+199 percent increase), and increase total box production for the last twelve months ending September 30, 2014 from approximately 3.4 million boxes on a standalone basis to approximately 10.0 million boxes on a pro forma basis (+189 percent increase).

Significant increase in EBITDA and free cash flow. The acquisitions are expected to drive significant increases in Alico’s earnings and free cash flow. Pro forma for the acquisitions and anticipated synergies, Alico would have generated 2014 Adjusted EBITDA of approximately $63 million. Pro forma capital expenditures are estimated to be approximately $7.5 million annually, excluding growth initiatives and one-time items. Pro forma interest expense is estimated to be approximately $9 million annually. The acquisitions provide for the company to retain the earnings and cash flow from Orange-Co’s and Gator Grove’s 2014/2015 harvest, which is expected to be completed by June 2015. The sale of the company’s sugarcane assets and the subsequent reinvestment of the sale proceeds into the Orange-Co assets were structured as a 1031 like-kind exchange, deferring the recognition of any taxable gain on the recently announced sale. In addition, the tax attributes of the acquired assets are expected to substantially reduce taxable income for the 2015 fiscal year.

Highly attractive, long-term financing package. The company secured attractive long-term financing to fund the acquisitions and refinance existing indebtedness. The company’s new debt facilities are comprised of $182.5 million of fixed-rate and floating-rate funded term loans with a 15-year term and a weighted average cost of 3.5 percent (based on current interest rates), as well as a $70 million working capital facility and a $25 million revolving line of credit. Pro forma for the acquisitions, anticipated synergies and the related financing transactions, the company’s net debt-to-EBITDA will be approximately 3.7x and EBITDA-to-interest expense will be approximately 6.9x. After taking effect for these transactions, the company will have approximately $70 million of available liquidity.

Positions the company for long-term growth. The company is capitalized in a manner that management believes can support additional growth through the investment of free cash flow and additional balance sheet capacity. Management expects to continue to actively evaluate the company’s portfolio, maximize cash flow from existing assets, redeploy capital as appropriate, and establish leading positions in each of its core business lines.

Raymond James acted as financial advisor and provided a fairness opinion to the company with respect to the Orange-Co acquisition. Wachtell, Lipton, Rosen & Katz acted as legal counsel to the company with respect to the Orange-Co and Silver Nip Citrus acquisitions. Houlihan Lokey provided a fairness opinion to a special committee of disinterested members of the Board of Directors of Alico in connection with the Silver Nip Citrus acquisition.

Use of Non-GAAP Financial Measures

This press release discloses certain financial measures that are considered non-GAAP financial measures. Generally, a non-GAAP financial measure is a numerical measure of a company’s financial performance, financial position or cash flows that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The company uses both Generally Accepted Accounting Principles (GAAP), and non-GAAP or adjusted financial measures, to evaluate and report the results of its business. A reconciliation of the non-GAAP financial measures to the comparable GAAP financial measure is available on the company’s home page at www.alicoinc.com at http://ir.stockpr.com/alicoinc/shareholder-information. As used herein, “GAAP” refers to the accounting principles generally accepted in the United States.

About Alico, Inc.

Alico is a holding company with assets and related operations in agriculture and natural resources. In addition to its citrus operations, Alico is currently involved in cattle ranching, water management, mining and other natural resources, including approximately 122,000 acres of agricultural assets (pro forma for the acquisitions) and 90,000 acres of mineral rights. In November 2013, 734 Investors, LLC acquired a controlling 51 percent stake in Alico. Subsequent to this investment, the company has executed on a strategy of optimizing assets and capital allocation. The company expects to continue this strategy by using its free cash flow and balance sheet capacity to execute additional acquisitions, where management believes it can add value and generate attractive returns for Alico’s shareholders.

Forward-Looking Statements

We provide forward-looking information in this release pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Any statements in this release that are not historical facts are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on our current expectations, estimates and projections about our business based, in part, on assumptions made by our management. These assumptions are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors, including those risk factors described in our Annual Report on Form 10-K for the year ended September 30, 2013 and our Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (“SEC”).

Additional Information About the Proposed Silver Nip Citrus Acquisition and Where to Find It

Investors and security holders are urged to carefully review and consider Alico’s public filings with the SEC, which may be obtained free of charge at Alico Inc.’s website at www.alicoinc.com or at the SEC’s website at www.sec.gov. These documents may also be obtained free of charge from Alico by requesting them in writing to Alico Inc., 10070 Daniels Interstate Court, Suite 100, Fort Myers, FL 33913, Attention: Investor Relations, or by telephone at (239) 226-2000.

In connection with the proposed acquisition of Silver Nip Citrus, Alico will file with the SEC an information statement of Alico and certain other documents regarding the proposed acquisition. Investors and security holders of Alico are urged to carefully read the entire information statement, when it becomes available, because it will contain important information about the proposed acquisition. Information about the directors and executive officers of Alico and their ownership of Alico common stock is set forth in the definitive proxy statement for Alico’s 2014 annual meeting of shareholders, as previously filed with the SEC on January 24, 2014.

Wednesday, December 3rd, 2014 Uncategorized Comments Off on (ALCO) Announces Three Strategic Acquisitions

(SQNM) & Illumina Noninvasive Prenatal Testing IP, End Outstanding Patent Disputes

Illumina, Inc. (NASDAQ: ILMN) and Sequenom, Inc. (NASDAQ: SQNM) today announced they have agreed to settle all pending infringement claims and other disputes between Sequenom and Verinata Health, Inc. The parties will pool their owned and in-licensed intellectual property directed to noninvasive prenatal testing (NIPT), including patents that will remain the subject of ongoing interference proceedings.

Under the agreement, Illumina will have exclusive worldwide rights to utilize the pooled intellectual property to develop and sell in-vitro diagnostic kits for NIPT and to license third-party laboratories wishing to develop and sell their own laboratory-developed NIPT tests under the collection of pooled patents. In addition, Sequenom and Illumina will each have rights to utilize all pooled patents to develop and sell their own respective laboratory-developed NIPT tests. The parties will share the revenue from the patent pool and Illumina will pay Sequenom a royalty on sales of in-vitro diagnostic kits for NIPT.

Illumina will make a $50 million upfront payment to Sequenom as part of the overall agreement, as well as certain ongoing commitments for payments to Sequenom from the patent pool structure through 2020.

“The patent pool established through this agreement eliminates confusion over intellectual property rights and provides a single point of contact for those wishing to license this intellectual property for NIPT testing,” said Jay Flatley, Chief Executive Officer for Illumina.

“This settlement will allow for easier access to both parties’ NIPT technology by healthcare providers and their patients,” said Bill Welch, Chief Executive Officer of Sequenom. “We believe that pooling our intellectual property will enable us to continue to expand our NIPT laboratory test offerings while allowing Sequenom to participate more broadly in the growing global NIPT marketplace.”

Separately, Illumina and Sequenom entered into an amended supply agreement whereby Illumina agreed to supply Sequenom with instruments and reagents for an additional five years.

“Sequenom and Illumina will now be able to utilize all of their pioneering intellectual property in the NIPT testing field in order to enable and deliver the highest quality NIPT tests to benefit physicians and their patients,” said Tristan Orpin, Senior Vice President and General Manager of Reproductive and Genetic Health for Illumina.

About Illumina

Illumina is transforming human health as the global leader in sequencing and array-based technologies. The company serves customers in a broad range of markets, enabling the adoption of genomic solutions in research and clinical settings. To learn how Illumina is unlocking the power of the genome, visit www.illumina.com and follow @illumina.

About Sequenom

Sequenom, Inc. (NASDAQ: SQNM) is a life sciences company committed to improving health care through revolutionary genomic and genetic analysis solutions. Sequenom develops innovative technologies, products, and diagnostic tests that target and serve molecular diagnostic markets. Web site: www.sequenom.com and follow @SQNM.

Illumina, Inc.
Investors:
Rebecca Chambers, 858-255-5243
rchambers@illumina.com
or
Media:
Jennifer Temple, 858-882-6822
pr@illumina.com
or
Sequenom Contacts:
Sequenom, Inc.
Carolyn Beaver, 858-202-9028
Chief Financial Officer
investorrelations@sequenom.com
or
Chandler Chicco Agency
Rachel Kennedy, 858-449-9575
Media Contact
rkennedy@chandlerchiccocompanies.com

Wednesday, December 3rd, 2014 Uncategorized Comments Off on (SQNM) & Illumina Noninvasive Prenatal Testing IP, End Outstanding Patent Disputes

(ARRY) To Regain Worldwide Rights To Binimetinib

– Array to receive up to $85 million upfront payment from Novartis – – Novartis to conduct and/or substantially fund all ongoing and several planned clinical studies, including COLUMBUS, NEMO and MILO – – Agreement subject to Novartis-GSK transaction close – – Conference call to discuss transaction on Thursday, December 4, 2014 at 9:00 a.m. Eastern Time –

BOULDER, Colo., Dec. 3, 2014  — Array BioPharma Inc. (NASDAQ: ARRY) today announced that it has reached a definitive agreement with Novartis International Pharmaceutical Ltd. to regain full worldwide rights to binimetinib, a MEK inhibitor in three Phase 3 trials.  This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline PLC (GSK) on April 22, 2014, which are expected in the first half of 2015, and remain subject to regulatory approval. Array had previously granted Novartis worldwide exclusive rights to develop and commercialize binimetinib under a 2010 License Agreement, which will terminate and be superseded by a new set of agreements between the parties.

“Regaining full worldwide rights to binimetinib, an innovative late-stage oncology product, represents a tremendous opportunity for Array,” said Ron Squarer, Chief Executive Officer, Array BioPharma.  “Binimetinib is currently advancing in three Phase 3 clinical trials and, we expect to file for our first regulatory approval during the first half of 2016.  With this agreement, we are in a strong position to successfully develop and commercialize binimetinib to the benefit of cancer patients.”

Novartis stated, “Binimetinib has demonstrated promising results for cancer patients across several different clinical trials.  We are committed to supporting a successful transition to Array.”

Terms of the Agreement
Upon deal close, Array will receive up to $85 million and Novartis’ global, exclusive license to binimetinib will terminate with all rights reverting to Array.  Novartis has agreed to provide transitional regulatory, clinical development and manufacturing services as specified below and will assign to Array patent and other intellectual property rights it owns to the extent relating to binimetinib.  All clinical trials involving binimetinib, including the COLUMBUS, NEMO and MILO pivotal trials, will continue to be conducted as currently contemplated.

Novartis will be responsible for continued conduct and funding of the COLUMBUS trial.  This obligation will transfer to any future owner of LGX818 (encorafenib).  Following deal close, Novartis will reimburse Array for all remaining out-of-pocket expenses and half of all remaining fully-burdened full time equivalent (FTE) costs associated with MILO, which Array will continue to conduct.  For NEMO and all other ongoing and planned clinical trials, Novartis will conduct and solely fund each trial, until a mutually agreed-upon transition date to Array.  Following this transition, Novartis will reimburse Array for all remaining out-of-pocket expenses and half of all remaining fully-burdened FTE costs required to complete these studies.

Novartis will remain responsible for conducting and funding development of the NRAS melanoma companion diagnostic until Premarket Approval is received from the U.S. Food and Drug Administration.  Following approval, Novartis will transfer the product and Premarket Approval to a diagnostic vendor of Array’s designation.

Novartis also retains binimetinib supply obligations for all clinical and commercial needs for up to 30 months after closing and will also assist Array in the technology and manufacturing transfer of binimetinib.  Novartis will also provide Array continued access to several Novartis pipeline compounds including, but not limited to, LEE011 (CDK 4/6 inhibitor) and BYL719 (α-PI3K inhibitor), for use in currently ongoing combination studies, and possible future studies, including Phase 3 trials, with binimetinib.

Conference Call Information
Array will hold a conference call on Thursday, December 4, 2014 at 9:00 a.m. Eastern Time to discuss this announcement.  Ron Squarer, Chief Executive Officer, will lead the call.

Date:            Thursday, December 4, 2014
Time: 9:00 a.m. Eastern Time
Toll-Free: (800) 708-4540
Toll: (847) 619-6397
Pass Code: 38529167
Webcast, including Replay and Conference Call Slides:
http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-EventDetails&EventId=5176145

 

About MEK and Binimetinib
MEK is a key protein kinase in the RAS/RAF/MEK/ERK pathway, which regulates several key cellular activities including proliferation, differentiation, migration, survival and angiogenesis. Inappropriate activation of this pathway has been shown to occur in many cancers, in particular through mutations in BRAF, KRAS and NRAS.  Binimetinib is a small-molecule MEK inhibitor that targets a key enzyme in this pathway.  Three Phase 3 trials with binimetinib in advanced cancer patients continue to enroll: NRAS-mutant melanoma (NEMO), low-grade serous ovarian cancer (MILO) and BRAF-mutant melanoma (COLUMBUS).  NRAS-mutant melanoma represents the first potential indication for binimetinib, with a projected regulatory filing estimated in the first half of 2016.

About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer.  Six Phase 3 studies on Array invented drugs, binimetinib (partnered with Novartis) and selumetinib (partnered with AstraZeneca), are currently enrolling patients with cancer. For more information on Array, please go to www.arraybiopharma.com.

Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the closing of the transaction with Novartis, the timing of the completion or initiation of further development of binimetinib, expectations that the return of rights to binimetinib to Array and other events will occur that will result in greater value for Array, the potential for the results of ongoing preclinical and clinical trials to support regulatory approval or the marketing success of a drug candidate, future plans to progress and develop binimetinib, and our plans to build a commercial-stage biopharmaceutical company. These statements involve significant risks and uncertainties, including those discussed in our most recent annual report filed on Form 10-K, in our quarterly reports filed on Form 10-Q, and in other reports filed by Array with the Securities and Exchange Commission. Because these statements reflect our current expectations concerning future events, our actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors. These factors include, but are not limited to, our ability to continue to fund and successfully progress our proprietary drugs; our ability to effectively and timely conduct clinical trials in light of increasing costs and difficulties in locating appropriate trial sites and in enrolling patients who meet the criteria for certain clinical trials; risks associated with our dependence on third-party service providers to successfully conduct clinical trials within and outside the United States; our ability to achieve and maintain profitability and maintain sufficient cash resources; and our ability to attract and retain experienced scientists and management. We are providing this information as of December 3, 2014. We undertake no duty to update any forward-looking statements to reflect the occurrence of events or circumstances after the date of such statements or of anticipated or unanticipated events that alter any assumptions underlying such statements.

CONTACT: Tricia Haugeto
  (303) 386-1193
thaugeto@arraybiopharma.com
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(ENPH) Selects Enphase Energy as Preferred Inverter Supplier

Enphase Energy, Inc. (NASDAQ:ENPH) announced today that the company has been selected as the preferred inverter supplier for Revolve Solar via its distribution arrangement with wholesale distributor CED Greentech. Revolve Solar is a rapidly growing full-service residential and commercial solar company, with operations in Redding, Chico and Vacaville, California, as well as its home office in Austin, Texas.

“We’ve been very successful with our consultative sales approach that emphasizes customer education, high-quality products and attractive financing options,” said Rick Davis, EVP of business development at Revolve Solar. “We spend time with our customers to help them understand that the Enphase system will significantly enhance the long-term return on their solar investment.”

“We’ve been selling Enphase products for many years and consider them a great channel partner who shares our commitment to integrity and reliability,” said Greg Bennett, manager of CED Greentech’s San Leandro, Calif., office. “As one of our fastest-growing customers, Revolve Solar appreciates CED’s proven ability to deliver system components on a timely basis so they can focus on sales and customer service rather than managing inventory.”

“Revolve is well known for its seasoned and highly disciplined sales organization focused on quality and customer service,” said Jeff Loebbaka, senior vice president of global sales, marketing and support at Enphase Energy. “Enphase systems offer the best solar solution for Revolve customers based on our superior performance, highest energy production, and ease of design and installation. As the preferred inverter provider for Revolve Solar, we are continuing our ongoing efforts to strengthen and grow our channel partnerships.”

About Revolve Solar

Founded in Austin, Texas, in 2012, Revolve Solar makes going solar easy and affordable. We help interested, qualifying candidates take the next step in energy evolution by utilizing local and federal incentives to install solar PV on the rooftops of their homes and small businesses. More PV in our communities means lower utility bills, stronger electrical grids and a cleaner environment. Since what goes around comes around, we trust that clean energy is just good, common sense. To us, a secure energy future means placing more energy choices in the hands of people—homeowners and business owners who see the value in reducing their dependency on polluting energy sources and enjoying the multitude of benefits that go along with utilizing true renewable energy sources. We hire installers locally to build the local solar community from our locations in California and Texas. RevolveSolar.com

About CED Greentech

CED Greentech is a division of Consolidated Electrical Distributors Inc., one of the largest electrical product wholesale distributors in the country. As a full-service wholesale distributor of solar, electrical and renewable energy products with 18 locations in the U.S., we are committed to providing superior service and support. We have an extensive onsite inventory featuring products from the solar and electrical industry’s top manufacturers. Whether your project is residential or commercial, we’re confident we’ll have what you need when you need it. www.cedgreentechus.com

About Enphase Energy, Inc.

Enphase Energy delivers microinverter technology for the solar industry that increases energy production, simplifies design and installation, improves system uptime and reliability, reduces fire safety risk and provides a platform for intelligent energy management. Our semiconductor-based microinverter system converts energy at the individual solar module level and brings a systems-based, high technology approach to solar energy generation. Connect with Enphase on Facebook and follow us on Twitter. www.enphase.com

Enphase Energy®, the Enphase logo and other trademarks or service names are the trademarks of Enphase Energy, Inc.

 

Enphase Energy
Michelle Taylor, 707-763-4784 x7362
Senior Manager, Global Corporate Communications
pr@enphaseenergy.com

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(VGGL) & HGTV Collaborate to Amplify TV Viewing Experience

Viggle Inc. (NASDAQ:VGGL), the entertainment marketing and rewards platform, today announced a strategic marketing partnership with HGTV. The partnership will create a cross-marketing platform to increase audience adoption and enhance HGTV viewers’ experience by providing them with exclusive points and rewards for engaging with HGTV programming across the Viggle Inc. platform, including the free Viggle app, Wetpaint.com and Viggle Reminders.

Fans who check-in to HGTV shows while using the Viggle app will receive bonus points and top-earning fans will be rewarded with HGTV prizes. The partnership includes the following key components:

  • Loyalty & Engagement: Viewers will earn 4X points for checking into any primetime HGTV programs from 8PM – 11PM ET/PT with the Viggle app, available on iOS, Android and Windows. Viggle will also produce play-along experiences for key HGTV programs to keep users engaged while tuned-in. Wetpaint will create custom articles and videos so fans can engage with HGTV before and after the shows.
  • Rewards: Fans who check-in the most to HGTV programs will earn top fan status and receive exclusive HGTV prizes and rewards from Viggle.
  • Tune-In Reminder & Social Tools: HGTV will have access to Viggle’s suite of Publisher Tools, including one click Reminders and Set DVR functionality across all its marketing channels, the ability to add Viggle Point earning capabilities across its own channels, and the use of Viggle Inc.’s proprietary Social Distribution technology.
  • Marketing: HGTV and Viggle will co-promote the special benefits on Viggle, as well as HGTV priority programming.
  • Data: HGTV will leverage check-in data to gain insights around viewing behavior and engagement.

“We’re thrilled to partner with one of the leading cable networks to offer engaging experiences and rewards for their top viewers,” said Greg Consiglio, president and COO of Viggle Inc. “We are constantly seeking innovative ways to make the TV experience more engaging and rewarding and this partnership exemplifies those goals on several levels. HGTV’s content is perfectly aligned for us to create unique promotions across the Viggle platform and our newly announced publisher tools will help fans of these shows to never miss an episode.”

The 15-month partnership kicks off in December, with Viggle providing the network a platform for reaching and engaging their target audience through their mobile devices while watching TV.

“By engaging with our targeted audience across multiple platforms, we are able to obtain key insights about our viewers beyond demographics,” said Shannon Driver, SVP of Marketing and Creative at Scripps Interactive. “The Viggle platform offers innovative loyalty solutions with targeting, reaching our core audience on their mobile devices while they watch TV, and we are excited to be able to offer this opportunity to our viewers.”

About Viggle Inc.

Viggle is an entertainment marketing and rewards platform whose app rewards its members for watching TV shows and discovering new music. Viggle Platform had total reach of 26.2 million in September 2014, including over 7 million Viggle registered users. Since its launch, Viggle members have redeemed over $20 million in rewards for watching their favorite TV programs and listening to music. Members can use Viggle’s store, accessible through the Viggle app or on Viggle.com, to redeem their Viggle Points for TV show, movie, and music downloads. In addition, Viggle operates Wetpaint, which offers entertainment and celebrity news online; NextGuide, maker of technology that helps consumers search for, find, and set reminders for TV shows and movies; and Choose Digital, a digital marketplace platform that allows companies to incorporate digital content into existing rewards and loyalty programs in support of marketing and sales initiatives. For more information, visit www.viggle.com or follow us on Twitter @Viggle.

About HGTV

America’s leading home and lifestyle brand, HGTV features a top-rated cable network that is distributed to more than 96 million U.S. households and HGTV.com, the premier source for home-related inspiration, instruction and entertainment, attracts more than six million people each month. The brand also includes the HGTV HOME™ consumer products line which showcases exclusive collections of paint, flooring, lighting, furniture, plants, fabrics and other home-oriented products. For more information on HGTV HOME branded products and to find a retailer, go to www.hgtvhome.com. In partnership with Hearst Magazines, the HGTV Magazine, a home and lifestyle publication, is currently available on newsstands. Viewers can become fans of HGTV and interact with other home improvement enthusiasts through Facebook, Twitter, Pinterest and Instagram. Headquartered in Knoxville, Tenn., HGTV is wholly owned by Scripps Networks Interactive, Inc. (SNI).

This press release may contain 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 involve inherent risks and uncertainties that could cause actual results to differ materially from those projected or anticipated. All information provided in this press release is as of the date of this release. Except as required by law, Viggle Inc. undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events.

 

For further investor and media information:
IRTH Communications
Robert Haag, 1-866-976-4784
Managing Partner
VGGL@irthcommunications.com
or
Viggle Inc.
John C. Small, 1-646-738-3220
CFO
john@viggle.com
or
Media Contact for Viggle:
DKC Public Relations
Paris Tyler, 1-212-981–5162
paris_tyler@dkcnews.com
or
Media Contact for HGTV:
Amy Hammontree, 1-865-560-4639
Director, Public Relations
ahammontree@hgtv.com

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(REI) Continues 2014 Development Program

Company Operates Profitably at Current Commodity Prices

Ring Energy, Inc. (NYSE MKT: REI) (“Ring” or the “Company”) today reaffirmed their 2014 development program and capital expenditure budget of $125 million. Management felt it necessary to reconfirm their stated 2014 development program because of the recent decline in commodity prices.

Through the first three quarters of 2014, the Company had drilled 92 new development wells on its Texas properties and is on pace to drill approximately 135 by year end. The Company continues to add acreage to its core Texas properties, as well as reduce the overall drilling and development costs. At the end of the year, management will evaluate the results and determine the 2015 expenditure budget.

As is the Company’s policy, a 2014 fourth quarter/year-end operations update will be released in early January 2015.

Mr. Kelly Hoffman, Ring CEO, stated, “We continue to execute our development plan and add acreage to our core properties. Our operations personnel are working hard to cut costs wherever possible. Because of the recent drop in commodity prices we will continue to monitor our expenditures closely. However, we currently have a strong balance sheet, unused credit facility and can continue to operate profitably at $60 oil.”

About Ring Energy, Inc.

Ring Energy, Inc. is an oil and gas exploration, development and production company with current operations in Texas and Kansas. www.ringenergy.com

Safe Harbor Statement

This release contains forward-looking statements within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995 that involve a wide variety of risks and uncertainties, including, without limitations, statements with respect to the Company’s strategy and prospects. Such statements are subject to certain risks and uncertainties which are disclosed in the Company’s reports filed with the SEC, including its Form 10-K for the fiscal year ended December 31, 2013, its Form 10-Q for the quarter ended September 30, 2014 and its other filings with the SEC. Readers and investors are cautioned that the Company’s actual results may differ materially from those described in the forward-looking statements due to a number of factors, including, but not limited to, the Company’s ability to acquire productive oil and/or gas properties or to successfully drill and complete oil and/or gas wells on such properties, general economic conditions both domestically and abroad, and the conduct of business by the Company, and other factors that may be more fully described in additional documents set forth by the Company.

K M Financial, Inc.
Bill Parsons, 702-489-4447

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(IDRA) Cancer Immunotherapy Regimen With Intratumoral IMO-2055

Data Highlight Potential Opportunity to Enhance Activity of Emerging Class of Checkpoint Inhibitors With Idera’s Proprietary Toll-Like Receptor Agonists

CAMBRIDGE, Mass., Dec. 2, 2014  — Idera Pharmaceuticals, Inc. (Nasdaq:IDRA), a clinical-stage biopharmaceutical company developing nucleic acid therapeutics for patients with cancer and rare diseases, today announced new preclinical data that showed cancer immunotherapy with intratumoral injections of IMO-2055 and ipilimumab demonstrated potent and systemic anti-tumor activity in multiple preclinical cancer models. IMO-2055 is a synthetic oligonucleotide-based agonist of Toll-like receptor (TLR) 9 discovered and developed by Idera. Ipilimumab is a checkpoint inhibitor targeting cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). The data were presented at the American Association for Cancer Research (AACR) Tumor Immunology and Immunotherapy Meeting in Orlando, Fla., earlier today.

In the presentation at the AACR meeting, Idera scientists summarized the results of several studies of IMO-2055 alone and in combination with ipilimumab in well-established preclinical models of bladder, colon and lung cancer. Results showed that intratumoral injections of IMO-2055 inhibited the growth of treated and distant tumors, as evaluated by tumor volume and histology. Compared to monotherapy with either agent, the combination regimen involving intratumoral injections of both agents demonstrated increased and sustained inhibition of treated and distant tumor growth. In addition, there were statistically significant increases in cytotoxic T cells against two antigens (AH1 and β-gal) expressed in treated and distant tumors, respectively, for the combination therapy versus monotherapy with either agent.

“In these preclinical models, intratumoral administration of a TLR 9 agonist enhanced the activity of a checkpoint inhibitor by inducing significantly greater anti-tumor immune responses against directly treated tumors and distant tumors representing models of metastatic cancer,” said Sudhir Agrawal, D.Phil., President of Research at Idera Pharmaceuticals. “Cancer immunotherapy represents an important and emerging area of oncology research, and combination regimens with agents such as IMO-2055 and ipilimumab or other checkpoint inhibitors may increase the ability to harness the body’s immune system to fight difficult-to-treat cancers in patients.”

“In addition to our ongoing and planned clinical development programs in genetically defined forms of B-cell lymphoma and rare diseases, Idera’s immuno-oncology research holds the promise of advancing cancer treatment for patients and driving value for the Company,” said Vincent Milano, Chief Executive Officer of Idera Pharmaceuticals. “With these compelling preclinical data, we are now assessing our options to advance a cancer immunotherapy program into clinical development. We look forward to unveiling those plans in 2015.”

The presentation, entitled “Intratumoral injection of IMO-2055, a novel Toll-like receptor 9 agonist, with ipilimumab induces a systemic tumor-specific immune response,” is available on Idera’s website at: http://www.iderapharma.com/our-science/key-presentations-and-publications. Ipilimumab is approved by the U.S. Food and Drug Administration for the treatment of unresectable or metastatic melanoma, and was developed by Bristol-Myers Squibb Company. The preclinical studies presented at the AACR meeting were conducted by scientists from Idera Pharmaceuticals.

About Toll-like Receptors and Idera’s Immuno-Oncology Research Program

Toll-like receptors (TLRs) play a central role in the innate immune system, the body’s first line of defense against invading pathogens, as well as damaged or dysfunctional cells including cancer cells. The innate immune system is also involved in activating the adaptive immune system, which marshals highly specific immune responses to target pathogens or tissue.

Cancer cells may exploit regulatory checkpoint pathways to avoid being recognized by the immune system, thereby shielding the tumor from immune attack. Checkpoint inhibitors such as agents targeting CTLA-4 or programmed cell death protein 1 (PD1) are designed to enable the immune system to recognize tumor cells. In this setting, a TLR 9 agonist may enhance the anti-tumor immune response by activating TLR signaling.

Based on the company’s proprietary chemistry-based discovery platform, Idera has designed and developed two synthetic oligonucleotide-based TLR 9 agonists, IMO-2055 and IMO-2125. In completed clinical trials, systemic administration of IMO-2055 was generally well tolerated as a monotherapy and in combination with other drugs in more than 300 patients with various types of cancers. In addition, systemic administration of IMO-2125 was generally well tolerated in about 80 patients with hepatitis C. Idera is currently conducting further preclinical research to evaluate the potential of IMO-2055 and IMO-2125 to enhance the anti-tumor activity of checkpoint inhibitors in cancer immunotherapy.

About Idera Pharmaceuticals   

Idera Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic approach for the treatment of genetically defined forms of B-cell lymphoma and rare autoimmune diseases. Idera’s proprietary technology involves creating novel nucleic acid therapeutics designed to inhibit over-activation of Toll-like receptors (TLRs). In addition to its TLR programs, Idera is developing gene silencing oligonucleotides (GSOs) that it has created using its proprietary technology to inhibit the production of disease-associated proteins by targeting RNA. To learn more about Idera, visit www.iderapharma.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the Company’s strategy, future operations, collaborations, intellectual property, cash resources, financial position, future revenues, projected costs, prospects, plans, and objectives of management, are forward-looking statements. The words “believes,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “could,” “should,” “potential,” “likely,” “projects,” “continue,” “will,” and “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Idera cannot guarantee that it will actually achieve the plans, intentions or expectations disclosed in its forward-looking statements and you should not place undue reliance on the Company’s forward-looking statements. There are a number of important factors that could cause Idera’s actual results to differ materially from those indicated or implied by its forward-looking statements. Factors that may cause such a difference include: whether results obtained in preclinical studies and clinical trials such as the preclinical data described in this release will be indicative of the results that will be generated in future clinical trials; whether products based on Idera’s technology will advance into or through the clinical trial process on a timely basis or at all and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if the Company’s products receive approval, they will be successfully distributed and marketed; whether the Company’s case resources are sufficient to fund the Company’s proposed programs and the Company’s operations for the period anticipated; and such other important factors as are set forth under the caption “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014. Although Idera may elect to do so at some point in the future, the Company does not assume any obligation to update any forward-looking statements and it disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

CONTACT: Investor and Media Contacts

         Robert Doody
         Vice President, Investor Relations
         and Corporate Communications
         484-639-7235
         rdoody@iderapharma.com

         Jim Baker
         Executive Director, Corporate Affairs
         617-679-5516
         jbaker@iderapharma.com
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(CLNT) Receives $2.2 Million in Orders for Oil Refinery Parts and Equipment

WUXI, China, Dec. 2, 2014 — Cleantech Solutions International, Inc. (“Cleantech Solutions” or “the Company”) (NASDAQ: CLNT), a manufacturer of metal components and assemblies used in various clean technology and manufacturing industries and textile dyeing and finishing machines, today announced that on November 28, 2014 it received a purchase order for a total purchase price of RMB13.3 million (approximately $2.2 million) from a subsidiary of China Petroleum and Chemical Corporation (“Sinopec”).  The purchase order covers parts and equipment including heat exchangers, coolers, reboilers, condensers and prefractionating columns used in offshore oil refineries.

Pursuant to the purchase order, Cleantech Solutions has received an advance payment of approximately RMB2.0 million ($0.3 million), or 15% of the purchase price, will receive an additional 75% of the purchase price upon delivery, and will receive the remaining 10% within three months of delivery subject to successful installation and testing at the customer’s site.  The Company expects to deliver the equipment in March 2015.

“This purchase order represents the first order we have received from the oil and gas industry since we became a certified supplier of parts and equipment to Sinopec and China National Petroleum Corporation (“CNPC”).  We are pleased to extend our business into a new end market with favorable prospects for growth driven by environmental imperatives that encourage petroleum companies to reduce emissions and upgrade their facilities.  We are hopeful that this order will be the first of many significant orders from the oil and gas industry as our reputation for supplying precision products to this sector grows,” said Mr. Jianhua Wu, Chairman and CEO of Cleantech Solutions.

About Cleantech Solutions International

Cleantech Solutions is a manufacturer of metal components and assemblies, primarily used in clean technology and other industries and dyeing and finishing equipment for the textile industry and forging products, and a supplier of fabricated products and machining services to a range of clean technology customers.  The Company’s website is www.cleantechsolutionsinternational.com. Any information on the Company’s website or any other website is not a part of this press release.

Safe Harbor Statement

This release contains certain “forward-looking statements” relating to the business of the Company and its subsidiary and affiliated companies. These forward looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects” or similar expressions. Such forward looking statements involve known and unknown risks and uncertainties that may cause actual results to be materially different from those described herein referred to in this press release as anticipated, believed, estimated or expected. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including our ability to deliver and install the equipment referred to in this press release and to receive additional orders from the oil and gas industry and those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website, including factors described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 10-K for the year ended December 31, 2013 and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 10-Q for the quarter ended September 30, 2014.  All forward-looking statements attributable to the Company or to persons acting on its behalf are expressly qualified in their entirety by these factors other than as required under the securities laws. The Company does not assume a duty to update these forward-looking statements.

Company Contact:

Cleantech Solutions International, Inc.
Adam Wasserman, CFO
E-mail: adamw@cleantechsolutionsinternational.com
Web: www.cleantechsolutionsinternational.com

Elaine Ketchmere, CFA
Compass Investor Relations
Phone: +1-310-528-3031
E-mail: eketchmere@compass-ir.com

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(MOLG) Largest Shareholder Makes Statement Supporting Company

KUALA LUMPUR, Malaysia, Dec. 2, 2014  — Mr. Vincent Tan, the largest shareholder of MOL Global, Inc. (Nasdaq:MOLG) today made the following statement in support of the company:

“MOL has encountered some difficulties over the last several days relating to an accounting error at its Vietnam subsidiary, a delayed earnings release and trading halt, and the departure of its CFO, Allan Wong. The timing of Allan’s departure for personal reasons which unfortunately coincided with the delay in the earnings release have resulted in some unhealthy speculation on the company’s financial numbers, and the stock price has been, in my view, unfairly punished.

“I have the utmost confidence in the management and MOL and none of these unfortunate events alters my very positive view of the underlying business of MOL. I have communicated my support to the management team at MOL, and while I know they are currently working very hard on addressing the issues that have arisen, I have encouraged them to continue to remain focused on executing their business plans.

“I also am very supportive of the board’s decision to implement a share buyback plan, as I believe that at the last closing price the stock is significantly undervalued.

Yours sincerely,

Tan Sri Dato’ Seri Vincent Tan Chee Yioun”

CONTACT: Tan Sri Vincent Tan
         Tel: 603-21491980
         Email: tsvt@berjaya.com.my

         MOL Global, Inc.
         Alvin Tan
         Tel: +65-6221-5680
         Email: IR@mol.com

         ICR, Inc.
         Calvin Jiang
         Tel: +1 (646) 405-4884
         Email: IR@mol.com
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