Biogen-Acorda MS Drug Faces Setback - Analyst Blog

Biogen Idec (BIIB) recently faced a pipeline setback with the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending against the approval of oral drug Fampyra (US trade name: Ampyra), aimed at improving walking speed in patients suffering from multiple sclerosis (MS).

Biogen plans to file a request for re-examination of the decision taken by the CHMP. We note that though the EMA is not bound to follow the CHMP's recommendation, it usually does so.

Ampyra has been developed by Acorda Therapeutics Inc. (ACOR), which has a licensing agreement with Biogen for the development and commercialization of the drug outside the US. Further, Acorda has a supply agreement with Elan Corporation (ELN) for manufacturing Ampyra.

Acorda received the US Food and Drug Administration's (FDA) approval, in late January 2010, for the marketing of Ampyra in the US for improving walking speed in patients suffering from MS.

The European Union (EU) does not have any approved drug for facilitating walking in patients suffering from MS. Fampyra, if approved in the EU, would therefore be able to establish itself in the market.

Ampyra is an extended release tablet formulation of dalfampridine. The drug enjoys orphan drug designation in the US, thereby providing it with seven years of market exclusivity.

Ampyra was found to be effective in patients with all four major MS types (relapsing remitting, secondary progressive, progressive relapsing and primary progressive). The drug can either be used alone or with existing treatments of MS, including immunomodulator drugs.

However, the FDA stated that Ampyra can cause seizures if patients take higher-than-recommended doses, and is best avoided by those suffering from moderate to severe kidney disease.

The MS market has big players like Pfizer Inc. (PFE) and Teva Pharmaceutical Industries Ltd. (TEVA). A chronic and usually progressive disease, MS affects the brain and nervous system, resulting in a loss of balance, muscle spasms and other problems related to movement.

We currently have Neutral recommendations on both Biogen and Acorda.