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TMCNet:  Teva Announces Full FDA Approval of SYNRIBO®; Aerpio Initiates Phase 2 Study of Tie2 Activator AKB-9778

[February 13, 2014]

Teva Announces Full FDA Approval of SYNRIBO®; Aerpio Initiates Phase 2 Study of Tie2 Activator AKB-9778

(BioMed Reports Via Acquire Media NewsEdge) Below is alook at some of the headlines for companies that made news in the healthcare sector on February 13, 2014.

{nfg}Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced that the U.S. FDA has granted full approval of SYNRIBO® (omacetaxine mepesuccinate) for injection. This oncology portfolio product received an accelerated approval in October, 2012 with additional clinical trial data required to fulfill post marketing requirements set forth by the FDA.


SYNRIBO is indicated for adult patients with chronic phase (CP) or accelerated phase (AP) chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs).

“With this approval, based on the final analysis of two Phase II trials that evaluated efficacy and tolerability data of SYNRIBO®, we believe healthcare providers can be even more confident in the clinical profile of this important medicine,” said Rob Koremans, M.D., President and CEO, Global Specialty Medicines. “This approval reinforces our ongoing commitment to providing SYNRIBO® to people living with CML who have failed two or more TKI therapies.“ Indication SYNRIBO® is indicated for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI).==========================Aerpio Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on advancing innovative therapies for vascular diseases, today announced that it has dosed the first patient in a Phase 2 trial evaluating AKB-9778, a Tie2 activator, alone and in combination with ranibizumab (Lucentis®) for the treatment of diabetic macular edema (DME). AKB-9778 is a first-in-class inhibitor of human protein tyrosine phosphatase beta (HPTPß) that activates the Tie2 pathway to promote vascular stability, preventing abnormal blood vessel growth and vascular leak.Aerpio announced at the American Academy of Ophthalmology 2013 the results of the Phase 1b/2a study in patients with DME, in which AKB-9778 administered subcutaneously as monotherapy over 28 days was well-tolerated and produced clinically meaningful reductions in retinal thickness, which correlated with improved visual acuity.“Emerging preclinical and clinical data indicate that the Angiopoietin/Tie2 pathway is a major axis for maintenance and stabilization of retinal blood vessels,” said Kevin Peters, MD, Chief Scientific Officer and VP of Research and Development, Aerpio. “Results in preclinical models and in our Phase 1b study indicate that AKB-9778 has great promise as monotherapy in both treatment-naïve and treatment-resistant DME patients. In addition, since Tie2 activation is complementary to the action of anti-VEGF agents, the current standard of care for patients with DME, AKB-9778 could also represent a major advance as an adjunct to anti-VEGF therapy.”“Alternative therapies are needed for treating patients with DME who have persistent macular edema and vision loss despite frequent anti-VEGF injections and also for patients who don’t want or don’t tolerate intravitreal injections,” said Jeffrey Heier, MD, Ophthalmic Consultants of Boston. “Based on a compelling scientific background of preclinical and early clinical data, AKB-9778 may provide a patient self-administered alternative that could be helpful in the treatment of diabetic macular edema.”The randomized, double-masked, double dummy, Phase 2 study is designed to assess the safety and efficacy of AKB-9778 administered over three months as monotherapy and as an adjunct with ranibizumab in subjects with DME. The primary endpoints of the study are change from baseline in visual acuity and change from baseline in central retinal thickness in the groups treated with AKB-9778 monotherapy and AKB-9778 as an adjunct with ranibizumab compared to ranibizumab monotherapy. The study will enroll approximately 120 subjects (40 patients/group) at approximately 35 sites.Also Thursday:Alcobra Ltd. (Nasdaq:ADHD), an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate, MG01CI (Metadoxine extended-release), to treat cognitive dysfunctions, such as Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, today announced its financial results for the quarter and year-ended December 31, 2013.Amedica Corporation (Nasdaq:AMDA) today announced the pricing of its initial public offering of 3,500,000 shares of common stock at a public offering price of $5.75 per share.BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today 15 data presentations at the Lysosomal Disease Network's 10th Annual WORLDSymposium™ from February 11-13 in San Diego, California.CannaVest Corp. (OTC: CANV), the world's leading hemp-based investment company spearheading the development of cannabidiol (CBD)-rich hemp oils and other cannabis industry-related products and services, and its wholly-owned subsidiary,PhytoSphere Systems, LLC, were recently featured by NBC 7 News in San Diego. The Cooper Companies, Inc. (NYSE:COO) will present at the Barclays Global Healthcare Conference in Miami, FL, on March 11, 2014. Ekso Bionics Holdings, Inc. (OTCQB:EKSO), a robotic exoskeleton company, today announced that it was named one of five startups poised to change MedTech forever by Medical Device & Diagnostic Industry Magazine. Entia Biosciences, Inc. (OTCQB: ERGO) and its wholly owned subsidiary Total Nutraceutical Solutions (TNS) has been notified that its GROH® Ergo Boost All-natural Hair and scalp conditioning treatment has received Readers' Choice awards in both the women's and men's hair care product categories from Beauty Launchpad magazine. The Ensign Group, Inc. (Nasdaq:ENSG), the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, assisted and independent living, home health, hospice care and urgent care companies, today reported operating results for the fourth quarter and full year 2013.Enzymotec Ltd. (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid ingredients, today reported financial results for the fourth quarter and full year ended December 31, 2013.Enzymotec Ltd. (Nasdaq:ENZY) today announced that it has filed a registration statement on Form F-1 with the Securities and Exchange Commission for a proposed secondary public offering of 4,000,000 of its ordinary shares. Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that Peter G. Traber, M.D., Chief Executive Officer, President and Chief Medical Officer of Galectin Therapeutics, served on a panel titled "Keeping an I on Oncology: The ASCO Immunotherapy Preview" at the 16th Annual BIO CEO & Investor Conference. Global Links Corp. (OTC:GLCO), today announced that the Company's wholly-owned subsidiary, Hemp Life Today, LLC, has experienced an increase in sales of its branded products since last week's launch of anew Marketplace Merchant Program™.Intuitive Surgical, Inc. (Nasdaq:ISRG) today reported that equity awards approved by the Compensation Committee of the Board of Directors, which consists entirely of Independent Directors, were made to 40 new employees. Pursuant to NASDAQ Marketplace Rule 5635(c)(4), the equity awards were granted under the Intuitive Surgical, Inc. 2009 Commencement Incentive Plan, which the Board of Directors of Intuitive Surgical, Inc. adopted for the granting of equity awards to new employees. M Line Holdings, Inc. (OTCQB:MLHC), a leading provider of products, assemblies and services to the precision high tech segment of both the aerospace and medical industries as well as a seller of high end pre-owned Japanese Computer Numerically Controlled ("CNC") Equipment, today announced its results for its second quarter and six months ended December 31, 2013.Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of innovative enterprise imaging, interoperability and clinical systems that seek to advance healthcare, announced today the scheduling of its fourth quarter 2013 earnings call, which will be held at 8:30 AM ET on Thursday, February 20, 2014.PDL BioPharma, Inc. (NASDAQ: PDLI) today announced that the Company has retained Stephen J. Hoffman, M.D., Ph.D. as senior advisor to the Company, effective as of February 3, 2014. PositiveID Corporation (OTCQB:PSID), a developer of biological detection and diagnostics solutions, today announced that its Chairman and CEO, William J. Caragol, will present at the National Investment Banking Association ("NIBA") Conference on February 27-28, 2014, at the Riverside Hotel in Fort Lauderdale, FL. Hospitals in Premier, Inc.'s (Nasdaq:PINC) QUEST® collaborative saved approximately $11.65 billion and avoided 136,375 deaths over the past five and a half years using the alliance's proven methodology and integrated analytics to set new standards of healthcare excellence.Premier, Inc. (Nasdaq:PINC) today reported financial results for the fiscal 2014 second quarter ended December 31, 2013.Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of product candidates focused on the prevention and treatment of serious infectious and other diseases, announced today that in view of the unusual market activity in the Company's stock, the NYSE MKT (the "Exchange") has contacted the Company in accordance with its usual practice. ThermoGenesis Corp. (Nasdaq:KOOL), a leading supplier of enabling technologies for the processing and storage of stem cells and other biological tissues, reported today that it received stockholder approval at a special meeting of the stockholders for the acquisition of TotipotentRX through a merger into ThermoGenesis. Incident to the acquisition, ThermoGenesis will also change its corporate name to Cesca Therapeutics Inc., which stands for Clinical Excellence in Stem Cell Applications.Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of pain-related conditions and central nervous system disorders, today announced the publication of results from the Phase 3 clinical study of ZohydroTM ER (hydrocodone bitartrate) extended-release capsules, which were originally reported in 2011 and were used as the basis for the Zohydro ER new drug application ("NDA"), which was approved by the U.S. Food and Drug Administration (FDA) in October 2013.

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