Acorda Therapeutics, Inc. (Nasdaq:
) today announced that the European Patent Office (EPO) Opposition Division has upheld amended claims covering a sustained release formulation of fampridine (known under the trade name FAMPYRA
), also known as dalfampridine or 4-aminopyridine, for increasing walking speed in patients with MS through twice daily dosing at 10 mg. The decision of the Opposition Division is open to appeal.
“We are pleased that the Opposition Division has recognized the validity of our patent claims for FAMPYRA,” said Ron Cohen, M.D., Acorda’s President and CEO.
This European patent (EP-1 732 548 B) is set to expire in 2025, absent any additional exclusivity granted based on regulatory review timelines. In addition, FAMPYRA received 10-year market exclusivity upon approval by the European Commission that is set to expire in 2021.
FAMPYRA is exclusively developed and commercialized outside the United States by Biogen Idec under a collaboration and licensing agreement with Acorda. FAMPYRA
is indicated in the European Union for the improvement of walking in adult patients with multiple sclerosis (MS) with walking disability (EDSS 4-7).
FAMPYRA is the ex-U.S. trade name for AMPYRA
(dalfampridine) Extended Release Tablets, 10mg, which is being developed and marketed in the United States by Acorda. AMPYRA is an oral medication approved by the U.S. Food and Drug Administration as a treatment to improve walking in patients with MS. This was demonstrated by an increase in walking speed.
In the United States, AMPYRA is covered by multiple patents providing coverage through 2027. In addition, AMPYRA
has Orphan drug status providing market exclusivity through January 22, 2017.
AMPYRA Important Safety Information
Do not take AMPYRA if you have ever had a seizure, or have certain types of kidney problems, or are allergic to dalfampridine (4-aminopyridine), the active ingredient in AMPYRA.