Regeneron Reports Two-Year Results from Phase 3 VISTA Trail of Eylea; Sarepta Announces Positive Safety Results from Phase I Trial of Marburg Print E-mail
By Staff and Wire Reports   
Monday, 10 February 2014 20:00
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 10, 2014.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
and Bayer HealthCare today announced that in the Phase 3 VISTA-DME trial of EYLEA^® (aflibercept) Injection for the treatment of diabetic macular edema (DME), EYLEA 2 milligrams (mg) dosed monthly (2Q4) and EYLEA 2 mg dosed every two months (after 5 initial monthly injections, 2Q8) showed a sustained improvement from baseline in best corrected visual acuity (BCVA) at week 100, compared to laser photocoagulation.  The 52-week results (primary analyses) from this study have been previously reported. 

Patients in the VISTA-DME trial were randomized to receive either EYLEA 2Q4 (n=155), EYLEA 2Q8 (n=152), or the comparator treatment of laser photocoagulation (n=154).

After two years, patients receiving EYLEA 2Q4 had a mean change from baseline in BCVA of 11.5 letters (12.5 letters at 52 weeks).  Patients receiving EYLEA 2Q8 had a mean change from baseline in BCVA of 11.1 letters (10.7 letters at 52 weeks).  Patients in the laser photocoagulation treatment group had a mean change from baseline in BCVA of 0.9 letters (0.2 letters at 52 weeks).

"These data showed that treatment with EYLEA in this trial improved vision and maintained the improvement over two years in patients with diabetic macular edema," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories.  "These results are particularly encouraging given that 43 percent of patients in this study had previously received anti-VEGF therapy."

In this trial, EYLEA was generally well tolerated with a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across the EYLEA treatment groups and the laser control group.  AEs were typical of those seen in other studies in patients with diabetes receiving intravitreal anti-VEGF therapy.  The most frequent ocular AEs observed in the VISTA-DME trial included conjunctival hemorrhage, eye pain, and vitreous floaters.  The most frequent non-ocular AEs included hypertension, anemia, and urinary tract infection.  Arterial thromboembolic events as defined by the Anti-Platelet Trialists' Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) were similar across the treatment groups and the laser control group with events occurring in 13 out of 155 patients in the EYLEA 2Q4 group, 11 out of 152 patients in the EYLEA 2Q8 group, and 9 out of 154 patients in the laser group.  Eight out of 155 patients died in the EYLEA 2Q4 group, 4 out of 152 patients in the EYLEA 2Q8 group, and 3 out of 154 patients in the laser treatment group.

Full two-year data from the VISTA-DME trial will be presented at upcoming medical conferences.  Two-year data from the similarly designed VIVID-DME trial are expected later in 2014.  Both the VISTA-DME and the VIVID-DME trials will continue as planned up to 148 weeks.



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Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a developer of innovative RNA-based therapeutics, today announced positive safety results from a Phase I multiple ascending dose study of AVI-7288 in healthy volunteers. AVI-7288, which uses Sarepta's advanced and proprietary PMOplus™ chemistry, is the company's lead drug candidate for the treatment of Marburg virus infection. Sarepta has been developing AVI-7288 under a Department of Defense contract managed by the Medical Countermeasure Systems BioDefense Therapeutics (MCS-BDTX) Joint Product Management Office.

The Phase I clinical study was a randomized, double-blind, placebo-controlled trial that enrolled 40 healthy adult volunteers, and was designed to characterize the safety, tolerability and pharmacokinetics of AVI-7288 after daily repeat dosing. In each of five cohorts, six subjects received AVI-7288 and two subjects received placebo, daily for 14 days. Results showed that AVI-7288 was well tolerated through the highest dose tested, 16 mg/kg per day, which is higher than the anticipated therapeutic dose, with no reported serious or clinically significant adverse events. An independent Data and Safety Monitoring Board reviewed blinded safety results from the study and recommended continued clinical development of AVI-7288.

“We are very encouraged by the AVI-7288 study results announced today,” said Chris Garabedian, president and chief executive officer of Sarepta Therapeutics. “These safety data, combined with previously reported efficacy results showing up to 100 percent survival in infected animals, differentiates AVI-7288 as the most advanced medical countermeasure in development for the treatment of Marburg infection.”

"The new data for AVI-7288 add to a growing body of evidence supporting the safety and activity of Sarepta's PMO-based chemistries,” said Art Krieg, M.D., senior vice president and chief scientific officer of Sarepta Therapeutics. “Our proprietary RNA technologies offer a versatile drug development platform with broad potential utility across a spectrum of therapeutic areas.”


Also Monday:


Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN)
announced today that Milind Deshpande, Ph.D., President and Chief Executive Officer of Achillion, will present a corporate overview at two upcoming investor conferences:  Leerink Global Healthcare Conference on Thursday, February 13, 2014 at 8:55 a.m. ET at the Waldorf Astoria Hotel in New York, NY; and Cowen and Company 34th Annual Health Care Conference on Monday, March 3, 2014 at 1:30 p.m. ET at The Boston Marriott Copley Place in Boston, MA.

Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR)
, a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases, today announced that Health Canada has granted a Notice of Compliance (NOC) approving JUXTAPID as an adjunct to a low-fat diet and other lipid-lowering drugs, with or without LDL apheresis, to reduce low-density lipoprotein cholesterol (LDL-C) in adult patients with homozygous familial hypercholesterolemia (HoFH).

Alphatec Holdings, Inc. (Nasdaq:ATEC)
, the parent company of Alphatec Spine, Inc., a medical device company that provides physician-inspired solutions for patients with spinal disorders, will release its fourth quarter and fiscal year 2013 financial results on Thursday, February 27th, 2014 after the close of the market.

AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG)
today announced that William Heiden, AMAG's chief executive officer, will participate in an analyst-led fireside chat at the Leerink Global Healthcare Conference in New York, NY.

Apricus Biosciences, Inc. (Nasdaq:APRI)
, today announced it has signed an exclusive license agreement with Recordati S.p.A. ("Recordati") (Bloomberg REC IM) to market Vitaros®, its topical on-demand product for the treatment of erectile dysfunction ("ED"), in Spain, Russia, Turkey, Ireland and certain other European and African countries (the "Territory").

Arrayit Corporation (OTCBB:ARYC)
, a life sciences and molecular diagnostics leader, is showcasing its high sensitivity, high specificity patented and proprietary microarray platform at the 21st International Molecular Medicine Tri-Conference in San Francisco, CA, USA on February 9-14, 2014.

Biocept, Inc. (Nasdaq:BIOC)
, an oncology diagnostics company focused on improving individual patient treatment, announced today the closing of its previously announced initial public offering of 1,900,000 shares of common stock, at a public offering price of $10.00 per share.

Biota Pharmaceuticals, Inc. (Nasdaq:BOTA)
today announced its financial results for the three month and six month periods ended December 31, 2013, and provided an update on recent corporate developments.

Cancer Genetics (Nasdaq:CGIX),
an emerging leader in DNA-based diagnostics, announced today that Panna Sharma, President and Chief Executive Officer of Cancer Genetics, will provide a corporate overview at the BIO CEO & Investor Conference, being held at the Waldorf Astoria Hotel in New York City on February 10-11, 2014.

Cancer Genetics, Inc. (Nasdaq:CGIX)
, an emerging leader in DNA-based diagnostics, and Roche Servicios S.A., an affiliate of Swiss drug maker Roche, have entered into an exclusive multi-year agreement to expand molecular diagnostic cancer testing in Central America and the Caribbean.

CannaVest Corp (OTCBB:CANV)
, already the world's largest industrial hemp company, is poised to lead the resurgence of the potential $1 billion domestic industrial hemp industry, through key company investments and acquisitions, including its Production and Manufacturing Division- US Hemp Oil (USHO).

Chembio Diagnostics, Inc. (Nasdaq:CEMI)
a leader in point-of-care diagnostic tests for infectious diseases, today provided an update on its discussions with the U.S. Food and Drug Administration (FDA) concerning the company's CLIA waiver application for its DPP® HIV 1/2 Assay.

Conatus Pharmaceuticals Inc. (Nasdaq:CNAT)
, a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced the appointment of two additional independent members to the Conatus Board of Directors: Daniel L. Kisner, M.D., a highly respected life sciences leader with demonstrated successes in drug development, pharmaceutical and research tool approvals, and venture capital investments; and Preston S. Klassen, M.D., M.H.S., an accomplished biopharmaceutical company executive with broad experience including clinical, regulatory, medical affairs and commercial responsibilities across multiple therapeutic areas.

EDAP TMS SA (Nasdaq:EDAP)
, the global leader in therapeutic ultrasound, announced today details relating to its fourth quarter and full year 2013 results announcement, which will take place on Thursday, April 3, 2014, before the opening of the market.

Elite Pharmaceuticals, Inc. (OTCBB:ELTP)
, a specialty pharmaceutical company dedicated to developing and commercializing oral sustained and controlled release product formulations and generics with high barriers to entry, announced today that management will host a conference call to provide a quarterly business update at 3:00 PM ET on Tuesday, February 18, 2014.

Five Prime Therapeutics, Inc. (Nasdaq:FPRX)
announced today the full exercise of the underwriters' option to purchase an additional 450,000 shares of common stock.

Groupe Athena, Inc. (OTC Pink: GATA)
today posted their quarterly results for the three months ending December 31, 2013. The company reported revenues of $17,961,452 which is an increase of 21% when compared to the corresponding period in 2012 and represents the strongest 6 month earnings period in the company's history.

GW Pharmaceuticals plc (Nasdaq:GWPH), (AIM:GWP)
, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that Dr. Stephen Wright, GW's Director of Research and Development, is scheduled to present at the Leerink Global Healthcare Conference on Wednesday, 12 February, 2014 at 3:30 p.m. ET.

Hansen Medical, Inc. (NASDAQ: HNSN)
, a global leader in intravascular robotics, today announced that current Board member Chris Lowe has been appointed Interim Chief Executive Officer effective yesterday.

Immunomedics, Inc. (Nasdaq:IMMU)
, a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today reported financial results for the second quarter ended December 31, 2013.

Innovative Software Technologies, Inc. (OTC: INIV.PK)
announces that The Florida Chiropractic Physician Organization and its daughter association, The Florida Chiropractic Physician Association, have entered into a strategic partnership with Opt-in SMART, Innovative's premier business platform.

Integra LifeSciences Holdings Corporation (Nasdaq: IART)
announced today that it will present at the following conferences next month:  At 10:30 AM ET on Wednesday, February 26, 2014, Mr. Peter Arduini, President and Chief Executive Officer of Integra LifeSciences, will present at the Citi 2014 Global Healthcare Conference in New York, NY. This presentation will not be webcast and at 3:05 PM ET on Wednesday, February 26, 2014, Mr. Arduini will also present at the 2014 RBC Capital Markets Healthcare Conference in New York, NY.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX)
, a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease, today announced the appointment of Greg Madison as Executive Vice President and Chief Operating Officer.

La Jolla Pharmaceutical Company (NASDAQ: LJPC)
and The French National Institute of Health and Medical Research ("INSERM"), today announced an exclusive worldwide license agreement to develop hepcidin agonists.

LHC Group, Inc. (Nasdaq:LHCG)
, a national provider of home health, hospice and comprehensive post-acute healthcare services, announced today that it has acquired two home health providers and has entered into a definitive asset purchase agreement to acquire one hospice provider.

MacroGenics, Inc. (Nasdaq:MGNX),
a clinical-stage biopharmaceutical company focused on discovering and identifying innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases, today announced that it has commenced an underwritten public offering of 2,500,000 shares of its common stock.

Medivation, Inc. (NASDAQ: MDVN)
today announced that it will host a live teleconference with management to discuss fourth quarter and year-end 2013 financial results and provide a general business update on February 27, 2014 at 4:30 p.m. Eastern Time.

Merge Healthcare Incorporated (Nasdaq:MRGE)
, a leading provider of innovative enterprise imaging, interoperability and clinical systems that seek to advance healthcare, today announced that Blanchard Valley Health System, a non-profit, integrated health system with more than 2,000 associates serving eight counties in Ohio, has selected Merge for its enterprise-wide vendor-neutral archive (VNA), interoperability and cardiology solutions to enable a seamless flow of information and meet Meaningful Use 2 (MU2) requirements for the exchange of images.

Novelos Therapeutics, Inc. (OTCQX:NVLT)
a biopharmaceutical company developing novel agents to detect, treat and monitor a broad spectrum of cancers, today announced that Dr. Simon Pedder, acting president and CEO of Novelos, will present at the 16th Annual BIO CEO & Investor Conference on Tuesday, February 11, 2014 at 10:30 am EST at the Waldorf Astoria in New York City.

Pacific Biosciences of California, Inc. (Nasdaq:PACB)
, provider of the PacBio® RS II DNA Sequencing System, announced that its Single Molecule, Real-Time (SMRT®) Sequencing technology will be featured in nine podium presentations and 29 posters at this year's Advances in Genome Biology and Technology (AGBT) meeting, with more than half presenting research on human and other complex genomes.

Poly Shield Technologies Inc., (OTCQB:SHPR)
announces the signing of a consulting agreement with DNV GL to test and evaluate Poly Shield Technologies Inc.'s DSOX-15 Fuel Purification System's technology. 

PTC Therapeutics, Inc. (NASDAQ: PTCT)
announced today that it has commenced an underwritten public offering of approximately $75 million of shares of its common stock.

Repros Therapeutics Inc.® (Nasdaq:RPRX)
today reported additional results from its ZA-300 six month study of Androxal® in men with secondary hypogonadism.

Sabra Health Care REIT, Inc. (Nasdaq:SBRA)
announced today that it will issue its 2013 fourth quarter earnings release after close of market on Wednesday, February 26, 2014.

ScripsAmerica, Inc. (OTCBB: SCRC)
today announced that the Company has received registration approval for its RapiMed® Children's Pain Reliever & Fever Reducer from the Government of Hong Kong.

The Spectranetics Corporation (Nasdaq: SPNC)
today announced that the Company will release 2013 fourth quarter and year-end financial results after market close on Thursday, February 27, 2014.

Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS)
today announced the appointment of Joseph I. DePinto to the newly created position of Executive Vice President and Chief Commercial Officer.

Tornier N.V. (Nasdaq:TRNX)
, a global medical device company focused on providing surgical solutions to orthopaedic extremity specialists, announced today that David Mowry, the Company's President and Chief Executive Officer, and Shawn McCormick, the Company's Chief Financial Officer, will present at the 2014 RBC Capital Markets Global Healthcare Conference.

Xenetic Biosciences, Inc. (OTCBB: GAIFD)
, a biopharmaceutical company developing next-generation biologic drugs and novel oncology therapeutics, today announced the appointment of Timothy Coté, MD, MPH, to the company's Board of Directors.

Youngevity International, Inc. (OTCQX: YGYI)
, a global direct marketer of nutritional and lifestyle products and also a vertically-integrated producer of gourmet coffees for the commercial, retail and direct sales channels, announced today the formation of MK Collaborative, a wholly owned subsidiary of Youngevity International, Inc.

ZELTIQ® (NASDAQ: ZLTQ)
, a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, announced today that it plans to release its fourth quarter and full year 2013 financial results on Tuesday, February 25, 2013 after the market close.



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