|POZEN Provides Positive Update on Its PA Program; Synergy Pharma Buys FV-100 Drug from Bristol-Myers|
|By Staff and Wire Reports|
|Thursday, 23 August 2012 19:04|
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced the results of the Company's Type A meeting with the U.S. Food and Drug Administration (FDA) regarding issues related to POZEN's planned New Drug Application (NDA) for PA32540 and PA8140 (high and lower dose versions of 325 mg aspirin delayed-release and 40 mg omeprazole immediate-release, and 81 mg aspirin delayed-release and 40 mg omeprazole immediate-release, respectively) for the secondary prevention of cardio - and cerebrovascular events and to reduce the risk of gastric ulcers in patients at risk of aspirin induced gastric ulcers.
The FDA confirmed that, although the Agency believes bioequivalence of PA32540 to enteric-coated Ecotrin(R) 325 mg, the Reference Listed Drug (RLD), was not strictly established in Study 115 according to the predetermined criteria, the results from Study 115, together with additional information that will be submitted in the NDA, constitutes sufficient data to support the establishment of a bridge to Ecotrin(R) 325 mg under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act.
The FDA will make a final determination during the NDA review. Based on our discussions with the FDA, POZEN does not plan to conduct any further bioequivalence studies with PA32540. The FDA also indicated that a similar strategy to bridge to the RLD under Section 505(b)(2), inclusive of a new, single pharmacokinetic study, could be utilized for a low dose version of PA32540 (currently, PA8140).
POZEN plans to conduct this study with the low dose version against the RLD, EC-Ecotrin(R) 81 mg, and submit these results and other supporting data in the NDA. POZEN also confirmed with the FDA that no additional clinical data would be submitted for a lower dose version and, in particular, that no Phase 3 program will be conducted.
Synergy Pharmaceuticals Inc. (Nasdaq: SGYP), a developer of new drugs to treat gastrointestinal disorders and diseases, announced it has signed an Asset Purchase Agreement with Bristol-Myers Squibb Company (NYSE: BMY) and has acquired the assets related to FV-100, an orally available nucleoside analogue, currently being developed for the treatment of shingles, a severe, painful skin rash caused by reactivation of the varicella zoster virus – the virus that causes chickenpox.
Alimera Sciences, Inc. (Nasdaq: ALIM) ("Alimera"), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that Rick Eiswirth, Chief Operating Officer and Chief Financial Officer, will present at the Stifel Nicolaus Healthcare Conference at 3:15 P.M. ET on Thursday, September 6, 2012 in Boston, MA.
Axia Group (PINKSHEETS:AGIJ) is pleased to report that the "DTCC CHILL" AGIJ has been straddled with over the last number of months has been removed.
Ingen Technologies, Inc. (PINKSHEETS: IGNT), an emerging medical device manufacturer with proprietary medical products for the growing $4 billion respiratory markets, announced today that the company has received a purchase order for 7,760 Oxyview® units on August 10, 2012.
Mauna Kea Technologies (NYSE Euronext: MKEA), leader in the endomicroscopy market and developer of Cellvizio® imaging, the fastest way to see cancer, today announced that clinicians have published more than 50 new scientific publications showing Cellvizio's clinical utility already in 2012, equal to the number of studies that were published during all of 2011.
Medical Marijuana Inc. (OTC: MJNA), a leading hemp industry innovator, is pleased to welcome Dr. Philip Van Damme, Director for CanChew Biotechnologies, to Small Cap Voice's Internet radio network.
Pivotal Therapeutics Inc. (OTCQX: PVTTF) (CNSX: PVO), a specialty pharmaceutical company with a focus on cardiovascular disease and overall health, is pleased to announce that the company will be exhibiting at the European Society of Cardiology (ESC) Congress 2012 in Munich, Germany August 25-29, 2012, Hall A2 Booth #B440.
Stellar Pharmaceuticals Inc. ("Stellar") (OTCQB:SLXCF) (OTCBB:SLXCF) (PINKSHEETS:SLXCF) today announced that it has signed an agreement granting Stellar the exclusive Canadian promotional rights for Gelfoam® from Pfizer Canada Inc. ("Pfizer") (NYSE:PFE).
University General Health System, Inc. (OTCQB: UGHS) (PINKSHEETS: UGHS) ("University General" or "the Company"), a diversified, integrated multi-specialty health delivery system, today announced that Donald Sapaugh, President, and Michael Griffin, Chief Financial Officer, will present at the 2012 Southern California Investor Conference on August 30, 2012 at 11:00 a.m. Pacific Time (PDT).