BIO updates Tuesday February 19, 2013
Gilead Sciences (Nasdaq: GILD) announced topline results from the Phase 3 FUSION study evaluating 12- and 16-week courses of therapy with the once-daily nucleotide sofosbuvir plus ribavirin (RBV) in treatment-experienced patients with genotype 2 or 3 chronic hepatitis C virus (HCV) infection who failed prior treatment. The study met its primary efficacy endpoint of superiority compared to a predefined historic control sustained virologic response (SVR) rate of 25 percent. In FUSION, 50 percent of patients (n=50/100) in the 12-week arm and 73 percent of patients (n=69/95) in the 16-week arm achieved SVR12 (p<0.001 for both arms).
“This study demonstrates that all-oral therapy with sofosbuvir provides significant efficacy among difficult-to-treat hepatitis C patients who could not be cured by prior regimens containing pegylated interferon and now have limited treatment options,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer. “With positive results from all four Phase 3 trials now in hand, Gilead is on track to meet its goal of filing regulatory applications in the United States and Europe in the second quarter.”
In the FUSION study, HCV genotype 2 or 3 patients who failed prior interferon-based therapy were randomized (1:1) to receive either a 12-week (n=103) or 16-week (n=98) course of sofosbuvir 400 mg once daily plus RBV (1,000 or 1,200 mg/day). Sixty-three percent of patients were infected with genotype 3. In the 12-week arm, SVR12 rates were 86 percent among genotype 2 and 30 percent among genotype 3 patients. In the 16-week arm, SVR12 rates were 94 percent among genotype 2 and 62 percent among genotype 3 patients. Among the 34 percent of FUSION participants who had compensated cirrhosis at baseline, 31 percent achieved SVR12 in the 12-week arm, and 66 percent achieved SVR12 in the 16-week arm. All patients in the study became HCV negative on treatment, and relapse accounted for all virologic failures.
No patients discontinued sofosbuvir or RBV due to adverse events. The most common adverse events reported in =15 percent of patients in the study were fatigue, headache, insomnia and nausea.
Results from all four pivotal Phase 3 studies of sofosbuvir – FUSION, POSITRON, FISSION and NEUTRINO – will support the initial regulatory filing for sofosbuvir as part of all-oral therapy with RBV among genotype 2 and 3 treatment-naïve, treatment-experienced and interferon-intolerant HCV patients, and for sofosbuvir in combination with RBV and pegylated interferon among treatment-naïve patients with genotypes 1, 4, 5 and 6.
Perrigo Company (Nasdaq: PRGO) announced it has filed with the U.S. FDA an Abbreviated New Drug Application for testosterone gel 1.62% and that it has notified AbbVie Inc., the owner of the Reference Listed Drug of its filing.
On February 15, 2013, the Unimed Pharmaceuticals subsidiary of AbbVie and Besins Healthcare filed suit against Perrigo in the United States District Court for the District of Delaware, alleging patent infringement. This action formally initiates the process under the Hatch-Waxman Act. Perrigo believes that it is a first filer for this opportunity, entitling it to 180 days of generic exclusivity.
Androgel® 1.62% (testosterone gel 1.62%) is indicated to treat males who have low or no testosterone. Annual sales were approximately $680 million annually, as measured by Wolters Kluwer Health.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This filing is another example of our investment in new products and continued focus on bringing extended topicals to market. As always, Perrigo is committed to making quality healthcare more affordable for our customers and consumers."
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it will present at the RBC Capital Markets and the Citi 2013 Global Healthcare conferences in February.
Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that the Brown University Oncology Research Group (BrUOG) will be coordinating a Phase 1/2 study of ADXS-HPV in 25 patients with HPV-associated anal cancer.
AirWare Labs Corp. (OTCQB: AIRW) today shares the market outlook for its AIR® product lineup in context to products sold within the OTC (Over-the-Counter) and Natural/Homeopathic Marketplaces.
Align Technology, Inc. (NASDAQ: ALGN) announced today the launch of a new interactive web site that provides a broad range of professional education resources for Invisalign providers.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will present at the RBC Capital Markets Healthcare Conference being held in New York City.
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial results for the fourth quarter and full year ended December 31, 2012.
BioMed Realty Trust, Inc. (NYSE: BMR) today announced the full exercise of the underwriters' option to purchase additional shares of common stock in connection with BioMed Realty's previously announced follow-on offering that priced on February 13, 2013.
Bruker Corporation (NASDAQ: BRKR) today reported financial results for its fourth quarter and full year ended December 31, 2012.
Capital Group Holdings, Inc. (OTCBB: CGHC) is pleased to announce it has received clearing from FINRA for its recently submitted 15c2-11 filing and its common stock is now quoted on the OTC Bulletin Board.
Capital Group Holdings, Inc. (OTCBB: CGHC) announced its consolidated results of operations for the quarter ending December 31, 2012.
China Cord Blood Corporation (NYSE: CO) (the "Company") today announced its plan to release financial results for the third quarter and first nine months of fiscal year 2013 on Tuesday, February 26, 2013, after market close in the US.
DARABiosciences (NASDAQ: DARA), a specialty pharmaceutical company focused on oncology and oncology supportive care products, is expecting to hear soon on the status of its Orphan Drug application submitted to The Food and Drug Administration (FDA) in November of last year for its drug KRN5500, which is being studied for the treatment of chronic chemotherapy-induced peripheral neuropathy (CCIPN).
DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM (NYSE, Euronext: DSM KON), announced today that it has signed a collaboration agreement with Chemtrix B.V., The Netherlands, in the field of Continuous Flow Chemistry.
Gilead Sciences (Nasdaq:GILD) today announced topline results from the Phase 3 FUSION study evaluating 12- and 16-week courses of therapy with the once-daily nucleotide sofosbuvir plus ribavirin (RBV) in treatment-experienced patients with genotype 2 or 3 chronic hepatitis C virus (HCV) infection who failed prior treatment.
GTx, Inc. (Nasdaq: GTXI) announced today that management will present a company overview on February 25, 2013 at the 2013 Citi Global Healthcare Conference in New York City. The GTx presentation will begin at 1.30 p.m. EST.
InSite Vision Incorporated (OTCBB: INSV) announced today that it will report financial results for the fourth quarter and year ended December 31, 2012 on Tuesday, March 5, 2013.
MediaTechnics Corporation (PINKSHEETS: MEDT) is pleased to announce that it executed an agreement to purchase a 51% interest in App Swarm Inc. ("ASI") in exchange for restricted preferred stock on February 11, 2012.
Mentor Capital, Inc. (Pink Sheets:MNTR) reports that its proprietary Cancer Immunotherapy Index declined (-10.9%) during 2012.
Morria Biopharmaceuticals Plc (OTCQB: MRRBY) (the "Company"), an emerging growth biopharmaceutical company focused on developing novel first-in-class, synthetic, multi-functional non-steroidal anti-inflammatory drugs, announced today that its American Depositary Shares ("ADSs") representing its ordinary shares have commenced trading on the OTC Bulletin Board in the United States under the ticker symbol MRRBY.
MMRGlobal, Inc. (OTCQB: MMRF) today announced that as a result of recent publicity, it has been brought to the Company's attention that vendors providing services to the Ministry of Health in Singapore appear to be infringing on patents (including Singapore patent number 200801954) and other Intellectual Property (collectively, the "MMR-IP") issued to MyMedicalRecords, Inc., a wholly owned subsidiary of MMRGlobal.
NanoViricides, Inc. (OTC: NNVC) (the "Company"), has filed its quarterly report with the Securities and Exchange Commission on Thursday, February 14th, in a timely fashion.
NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, today reported business and financial highlights for the quarter and twelve months ended December 31, 2012.
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that Dr. Mark Pykett, President and Chief Executive Officer, will participate at the Citi 2013 Global Healthcare Conference on February 25-27, 2013 at the Hilton New York Hotel in New York City.
Oncolytics Biotech Inc.("Oncolytics") (TSX:ONC; NASDAQ: ONCY) announced today its intention, subject to market and other conditions, to commence an underwritten public offering of common shares.
Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets, announced today that the European Medicines Agency (EMA) has designated Osiris as the Orphan Drug title holder for Prochymal® (remestemcel-L).
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today announced thatthey have initiated a new Phase 3 trial (named VIVID EAST-DME) to evaluate the efficacy and safety of EYLEA® (aflibercept) Injection in the treatment of Diabetic Macular Edema (DME) in Russia, China, and other Asian countries.
RXi Pharmaceuticals Corporation (OTC: RXII), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted technologies, today announced upcoming presentations at AsiaTIDES and at the ROTH 25th Annual Conference.
Santarus, Inc. (NASDAQ: SNTS) today announced that it will release fourth quarter 2012 financial results after market close on Monday, March 4, 2013.
Sobi (STO: SOBI) and Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) announced today that they have entered into an agreement for the co-promotion of Kineret® (anakinra) in the U.S.
ServiceSource® (NASDAQ: SREV), the global leader in recurring revenue management, today announced that it has expanded its partnership with GE Healthcare (NYSE: GE) to include Japan.
Teleflex Incorporated (NYSE: TFX) announced today the addition of the AutoFuser® disposable pain pump to its portfolio of Arrow® pain management products.
Today eHealth, Inc. (NASDAQ: EHTH) (eHealthInsurance.com), America's first and largest private online health insurance exchange, released a series of tips for health insurance consumers preparing to file their 2012 federal tax returns.
United Therapeutics Corporation (NASDAQ: UTHR) announced today that it will release its fourth quarter and annual 2012 financial results before market open on Tuesday, February 26, 2013.
VentriPoint Diagnostics (TSX VENTURE:VPT) (OTCQX:VPTDF) is providing a status report on its 2D echocardiographic (2DE) products, clinical research and regulatory submission plans.
Vermillion, Inc. (NASDAQ: VRML), a molecular diagnostics company focused on gynecologic cancers and vascular medicine, has been invited to participate in Lazard Capital Market's 5th Annual Medical Technology Snowbird Conference.
Vermillion, Inc. (NASDAQ: VRML), a molecular diagnostics company focused on gynecologic cancers and vascular medicine, will hold a conference call on Wednesday, February 20, 2013, at 4:30 p.m. ET to discuss full results for its fourth quarter and year ended December 31, 2012.
Verisante Technology, Inc. (TSX VENTURE:VRS) (OTCQX:VRSEF) (FRANKFURT:V3T) (the "Company" or "Verisante"), a leader in cancer detection technology, announced today that the Company has entered into an exclusive agreement with Pacifica Handels AG to distribute Verisante Aura™ in Switzerland.
WaferGen Bio-systems, Inc. (OTCBB: WGBS) announced today a co-marketing agreement with QIAGEN KK – a subsidiary of QIAGEN N.V.– for the joint promotion of certain products in Japan in the areas of genomics platforms such as Next-Gen sequencing (NGS) and qPCR.
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