Acorda Therapeutics, Inc. 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 - Analyst Report) 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.
At present, companies like Isis Pharmaceuticals and Alexion (ALXN - Analyst Report) look attractive. Both are Zacks Rank #1 (Strong Buy) stocks.