--Comes after Biogen appealed January rejection --Already approved in U.S. as Ampyra --Acorda, Elan to get payments from approval By Thomas Gryta Of DOW JONES NEWSWIRES NEW YORK -(Dow Jones)- Biogen Idec Inc. (BIIB) received conditional approval of multiple sclerosis pill Fampyra in Europe, after a positive recommendation in May that followed an earlier rejection. The drug, developed by Acorda Therapeutics (ACOR) and licensed to Biogen for sales outside the U.S., is designed to improve walking by MS patients. It was approved in the U.S. last year under the name Ampyra. Biogen shares recently traded up 20 cents to $105.76, Acorda shares dropped 1.4% to $29.25, and Elan rose seven cents to $12.41. The conditional approval is renewable annually. Under terms of the decision, Biogen will gather data on the long-term effectiveness and safety of the drug, including its benefits beyond walking-speed improvements. The move is similar to accelerated approval by the U.S. Food and Drug Administration, which allows drugs on the market with the requirement to provide later data to gain full approval. Ampyra already has full FDA approval. European regulators recommended the approval in May, after Biogen appealed a January rejection by the Committee for Medicinal Products for Human Use, known as CHMP, of the European Medicines Agency, which questioned the effectiveness of the drug. Acorda will get a $25 million payment with the European approval and collect an increasing double-digit royalty. Acorda will pay 7% of milestone payments to Elan (ELN, ELN.DB). Lazard Capital Markets projects that overseas sales of the drug will be $16 million this year, rising to $221 million in 2014 and bringing Acorda royalties of $2.4 million and $34 million, respectively. Acorda reported first-quarter Ampyra sales of $46.8 million. Acorda signed a partnership in 2009 for Biogen to market and develop the drug, also known as fampridine-SR, outside the U.S. Fanpyra will be available in Germany in September, with other countries in the region following. Biogen is scheduled to report second-quarter earnings results early Tuesday. -By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com
