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Acorda Therapeutics and Biogen Idec Get EU Recommendation For MS Drug

posted May 20, 2011, 6:07 PM by Bryce Istvan   [ updated May 20, 2011, 7:08 PM ]

Fampyra, a drug that increases nerve conductivity and improves walking function in MS patients by keeping potassium from exiting the nerves, was recommended for conditional marketing approval by the Committee for Medicinal Products for Human Use (CHMP) which is a part of the European Medicine Agency. Fampyra is developed by Acorda Therapeutics (ACOR +$3.67 13.74%) and has been sold in the U.S. under the name Ampyra since receiving FDA approval in January of 2010. Earlier this month Fampyra received approval for sale in Australia. Biogen Idec (BIIB) controls the marketing rights to Fampyra outside the United States. As part of the license agreement EMA approval, which Biogen expects will be issued within 67 days, would trigger a $25 million payment from Biogen to Acorda and Acorda may receive additional payments of up to $375 million based on the successful achievement of future regulatory and sales milestones. Acorda also receives a double-digit royalty from Biogen Idec based on net sales of FAMPYRA in all markets outside the United States. 

A third winner in this approval is Elan (ELN) which, under an agreement with Acorda, is due to receive 7% of any milestone payments.

Also recommended for approval today were:
Benlysta, a lupus drug from Human Genome Sciences and GlaxoSmithKline
Victrelis, the Hep C drug from Merck which I wrote about last week
Xgeva a drug for treatment of bone complications due to cancer
and Yervoy, a skin cancer treatment from Bristol-Myers Squibb