Biogen, Acorda MS Drug Gets Conditional European Approval
July 25 2011 - 11:44AM
Dow Jones News
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
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