|FDA rejects Orexigen diet drug, shares plunge. Valeant Pharma buying PharmaSwiss. Parexel slumps on lowered outlook|
|By Mary Davila|
|Tuesday, 01 February 2011 19:49|
Shares of Orexigen Therapeutics, Inc. (Nasdaq:OREX) fell sharply today after the company, along with its partner, Takeda Pharmaceutical Company Limited (TSE:4502.to) announced that a Complete Response Letter was received from the FDA for the company's experimental weight loss drug, Contrave. The FDA sited concerns with the cardiovascular safety profile for the drug, specifically stating; "before your application can be approved, you must conduct a randomized, double-blind, placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with naltrexone/bupropion does not adversely affect the drug's benefit-risk profile."
In response to the FDA letter, Michale Narachi, President an CEO of Orexigen said, "We are surprised and extremely disappointed with the Agency's request in light of the extensive discussion and resulting vote on this topic at the December 7 Advisory Committee meeting. We plan to work closely with the Agency to gain more information to determine the appropriate next steps regarding the Contrave application."
187 million shares traded hands as shares of Orexigen plunged $6.59 or 72.50% $2.50. Meanwhile, VIVUS (Nasdaq: VVUS) which is working on its on weight loss pill tanked 15.42% or $1.38 to $7.57, while Arena (Nasdaq:ARNA), which is developing a weight management drug, lorcaserin, bucked the trend and gained 10 cents or 6% to $1.68.
Shares of Valeant Pharmaceuticals International, Inc. (NYSE:VRX) (TSX:VRX.to) moved higher today after the company announced that it will acquire PharmaSwiss, a privately-owned branded generics and over-the-counter pharmaceutical company based in Zug, Switzerland for euro 350 million or about $480 million U.S.
PharmaSwiss has a broad product portfolio in seven therapeutic areas and operations in nineteen countries throughout Central and Eastern Europe, including Poland, Hungary, the Czech Republic and Serbia as well as operations in Greece and Israel. PharmaSwiss is also partnered with several large pharmaceutical and biotech companies offering regional expertise in such functions as regulatory, compliance, sales, marketing and distribution.
Shares of Valeant gained $2.46 or 6.73% to $38.99.
PAREXEL International Corporation (Nasdaq:PRXL) slumped nearly 10% today after the company lowered its 2011 forecast. The company said it is taking longer than expected to acquire new contracts from drugmakers. The company specifically pointed out delays in converting its partnerships with Bristol-Meyers Squibb and Merck into contracts.
Shares lost $2.29 or nearly 10%, closing the day at $20.92.
Antares Pharma, Inc. (NYSE Amex: AIS) today announced that the first patient has been dosed in a clinical study evaluating the VIBEX MTX product which is being developed for the treatment of rheumatoid arthritis. The clinical study will evaluate several dose strengths of VIBEX MTX delivered with a proprietary autoinjector versus conventional needle and syringe administration by a healthcare professional.
BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that it has initiated a pivotal Phase III trial for N-acetylgalactosamine 6-sulfatase (GALNS or BMN 110), intended for the treatment of the lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), also called Morquio A Syndrome.
"In under two years, we have progressed the GALNS program from Clinical Trial Application to initiation of the Phase III trial. We have received FDA feedback and have finalized the design of the Phase 3 pivotal trial," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin.
Lannett Company, Inc. (AMEX:LCI), a manufacturer of generic pharmaceuticals, today announced that it recently met with the U.S. Food and Drug Administration to discuss the status of the company’s New Drug Application for Morphine Sulfate Oral Solution as well as other pending product applications. The FDA informed the company that it intends to conduct a Pre-approval Inspection of Lannett’s manufacturing facility as part of its review of the Morphine Sulfate NDA.
The company said its manufacturing facilities were previously inspected by the FDA in January and February 2010, and it responded to the observations within seven days. The FDA conducted a follow-up inspection in September, resulting in zero observations at Lannett’s plants in Philadelphia and a total of two minor 483 observations at its pain management products facility in Wyoming.
Arthur Bedrosian, president and chief executive officer of Lannett, said, "The FDA indicated to us that it will approve our Morphine Sulfate NDA and certain other pending product applications, subject to our manufacturing facility passing the PAI, which we expect to occur shortly." Shares gained 20 cents to $5.43.
Nutra Pharma Corporation (OTC.BB:NPHC) a biotechnology company that is developing treatments for Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy (AMN) and Pain, announced the Publication of a Review Article, "Cobra Venom: A Review of the Old Alternative to Opiate Analgesics," Published in the January Issue of the Journal Alternative Therapies in Health and Medicine.
Omeros Corporation (Nasdaq:OMER) today announced that the European Medicines Agency has confirmed that OMS103HP is eligible to be submitted for marketing approval in the European Union through the EMA centralized procedure. OMS103HP is Omeros' lead product candidate currently in a Phase III clinical program evaluating the drug's safety and ability to improve postoperative joint function and reduce pain following anterior cruciate ligament (ACL) reconstruction surgery. Omeros continues to expect the release of Phase III results this quarter.
Rosetta Genomics, Ltd. (NASDAQ:ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces that it has signed two new agreements for the development and validation of microRNA-based diagnostics for various indications related to its Gen 3 products. The Company's Gen 3 tests will focus on cardiovascular indications, neurodegenerative diseases, women's health and early detection of certain cancers, and are designed to leverage microRNA biomarkers extracted from body fluids.
BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, is pleased to announce it has retained Scarsdale Equities LLC as its financial advisor to explore various strategic alternatives.