Acorda Therapeutics, Inc. (ACOR) continues to work on expanding the label of its lead product, Ampyra (dalfampridine-ER). Ampyra is currently approved for the improvement of walking in multiple sclerosis patients. It is available outside the U.S. under the trade name Fampyra. Acorda has a license and collaboration agreement with Biogen Idec (BIIB) for the development and commercialization of Fampyra outside the U.S.
Ampyra is being studied for other indications as well including cerebral palsy (encouraging efficacy data presented from a phase II proof-of-concept study) and post-stroke deficits.
Earlier this week, Acorda presented phase II data on the post-stroke deficits indication at the annual meeting of the American Neurological Association. Results from the proof-of-concept study showed that Ampyra was well-tolerated and improved walking as measured by the Timed 25-Foot Walk test (T25FW). Top-line data from this study had been released earlier this year in April.
The study was mainly conducted to evaluate the safety and tolerability of Ampyra – other efficacy measures were also studied. Acorda intends to commence a phase IIb/III study for the post-stroke deficits indication potentially in the second quarter of 2014.
Acorda currently carries a Zacks Rank #4 (Sell). We remain concerned about the company’s dependence on Ampyra for growth. The company’s pipeline, while interesting, is primarily early-stage in nature apart from diazepam nasal spray. Most candidates are quite a few years away from hitting the market.