In Biotech: Acorda MS Drug Gains Recommended Approval

The biotech sector was abuzz today following the announcement that Acorda Therapeutics Inc. (NASDAQ: ACOR) and partner Biogen Idec (NASDAQ:BIIB), received recommended approval from the European regulatory panel for the multiple sclerosis drug, Fampyra. Fampyra is intended to maximize walking ability for those afflicted with MS.

Acorda, who gave the announcement on behalf of the two companies, said that it anticipates the drug to receive conditional approval from the European Commission within 67 days. The conditional approval entails the mandatory submission of additional information for Fampyra to stay on the market. Earlier this year an EU panel rejected the product, resulting in strong backlash for its share prices.

This latest news can be expected to elicit the opposite response in anticipation of a major influx of payments for the drug. The commercial rights to Fampyra outside the U.S. belong to Biogen. Beneath that contract, the European approval requires a milestone payment of $25 million to Acorda, with 7 percent of that bound to Irish drug maker, Elan Corp (NYSE: ELN).  Beyond the initial $25 million, Acorda is positioned to receive an additional $375 million in future milestone payment, as well as royalties on foreign sales.

Elsewhere in biotech, Celldex  (NASDAQ:CLDX) announced plans to sell 10 million shares at $3.15 each. The company, which is focused  on the development of new classes of diagnostic and therapeutic products for the detection, monitoring, and treatment of immune disorders and autoimmune diseases, anticipated generating around $29.4 million from the transaction, which is scheduled to close on or near May 23. The net proceeds from the offering are anticipated for primary use on Celldex’s clinical trials of its product candidates and for working capital.

The Irish drug maker Shire (NASDAQ: SHPGY) also announced plans to purchase skin-graft specialist Advanced BioHealing for $750 million. The decision derails expectations that Advanced BioHealing would announce a public offering of between 13.4 million shares at between $14 and $16 a share.

Three other companies, Arena (NASDAQ: ARNA), Vivus (NASDAQ: VVUS) and Albany Molecular Research (NASDAQ: AMRI) have been garnering investor interest on the basis of new obesity medication in their pipeline, in advance of a major medical meeting on the subject scheduled for next week. Arena Pharmaceuticals Inc. is set to present on its drug Lorcasering Hydrochloride which is designed for weight loss and management. The completion of phase III trials for the product indicated statistically significant results for Lorcasering and it’s currently awaiting FDA approval.  Vivus Inc, is set to present on its drug QNEXA, which in phase III trials exceeded FDA efficacy benchmarks for weight loss agents at all three doses studied and resulted in significant improvements in cardiovascular, metabolic and inflammatory risk factors, according to their website. Albany Molecular Research Inc. will present results from a Phase 1 clinical study with its Melanin Concentrating Hormone Receptor 1 (MCH₁) antagonist, ALB-127158(a). The conference, held at the European Congress on Obesity is set to be held May 25 to 28 in Istanbul.