|Pfizer to Seek Approval for Menopause Drug; PharMerica Comments on FTC Decision|
|By Staff and Wire Reports|
|Monday, 30 January 2012 19:38|
Pfizer Inc. (NYSE:PFE) is preparing to seek U.S. regulatory approval to sell a new menopause drug that could pose an alternative to the company's older hormone-replacement therapies, which have been tied to safety risks.
However, repeated delays in developing the new drug, Aprela, have raised questions about its potential. Some analysts and doctors question whether regulators will approve it, and Aprela's market potential could be limited by continued safety concerns about hormone-based drugs. The New York-based drug maker expects to submit Aprela for Food and Drug Administration approval sometime this year, according to Olivier Brandicourt, president and general manager of Pfizer's primary-care unit. He discussed Aprela in an interview earlier this month.
Mr. Brandicourt said the drug has the potential to reduce menopausal symptoms such as hot flashes and to prevent bone-thinning osteoporosis, but with a better safety and tolerability profile than older hormone-replacement therapies. "We think this is a market which is unsatisfied … and if you can bring a hormone therapy which doesn't have the traditional side effects, we can actually lead that marketplace," Mr. Brandicourt told reporters at a November meeting.
PharMerica Corporation (NYSE:PMC), a national provider of institutional pharmacy and hospital pharmacy management services, today commented on the decision by the Federal Trade Commission (FTC) to sue to block Omnicare’s (NYSE: OCR) unsolicited offer to acquire PharMerica.
“We are pleased the FTC has made a prompt decision to resolve the competitive issues surrounding Omnicare’s attempted hostile takeover of PharMerica Corporation,” said Gregory S. Weishar, PharMerica Chief Executive Officer. “As we have said from the beginning, we believed antitrust clearance would be difficult to achieve and, with that belief now confirmed, we hope that Omnicare will end its hostile pursuit of PharMerica.
"We believe PharMerica is well positioned to deliver outstanding value for customers and stockholders as we pursue our strategic initiatives and head into the accelerating wave of generic drug conversions in 2012 and beyond.”
Deutsche Bank Securities Inc. is acting as financial advisor and Holland & Knight LLP and Covington & Burling LLP are acting as legal advisors to PharMerica.
BIOLASE Technology, Inc. (NASDAQ: BLTI), the World's leading dental laser manufacturer and distributor, today announced that it has signed a strategic sales and marketing partnership with Kirkland, WA-based Seattle Study Club (SSC), a worldwide organization of dentists that are committed to the highest standard of patient care and maintaining the highest level of knowledge in the field of dentistry.
Biosign Technologies Inc. (TSX VENTURE:BIO) ("Biosign") and EasyMed Services Inc. (CNSX:EZM )(OTCBB:EMYSF) ("EasyMed") are pleased to announce they have executed agreements that allow the resale and distribution of each other's respective products as well as a Development and License Agreement for the creation of a joint product offering.
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, plans to announce its operating results for the quarter ended December 31, 2011 after the market closes on Thursday, February 2, 2012 and will host a conference call at 5:00 p.m. ET that day to discuss its results.
PROTEONOMIX, INC. (OTCBB: PROT), a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, announced today that it will be presenting at the Investor Summit 2012 on February 1, 2012, sponsored by Merriman Capital at the Intercontinental Time Square Hotel in New York City.
Rock Creek Pharmaceuticals, Inc., a subsidiary of Star Scientific, Inc. (NASDAQ: CIGX), has completed the first successful human clinical trial showing that Anatabloc™, the dietary supplement developed by Rock Creek to provide anti-inflammatory support, lowers C-reactive protein (CRP) levels in subjects' blood.
Rosetta Genomics, Ltd. ("Rosetta") (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, today announced it has sold an aggregate of $1.75 million in senior secured debentures in a private placement transaction with an accredited investor, and Rosetta has also agreed to negotiate in good faith a definitive license agreement with a designee of the holders of the debentures for an additional $1.25 million.
TheDirectory.com, Inc. (PINKSHEETS: SEEK) today announced that it has completed its platform integration of functionality allowing it to manage over 100,000 client websites and Local Business Listings from a single location.