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Acorda Therapeutics, Inc. (ACOR - Analyst Report) recently announced the enrollment of the first patient in a proof-of-concept study exploring the use of Ampyra in patients with post stroke deficits after an ischemic stroke.
Ampyra’s safety and tolerability will be evaluated in the study (n=66). The enrolled subjects must have experienced ischemic stroke at least six months prior to enrollment. Initial results should be out in early 2013.
According to Acorda, more than 7 million people have suffered a stroke in the US with about 800,000 new cases of stroke occurring every year in the country. The company further adds that more than half of the stroke survivors either have ongoing sensorimotor or walking impairments, or both. No pharmaceutical treatment is currently available for these impairments – this provides Acorda with significant commercial opportunity if Ampyra is developed successfully for this patient population.
Apart from this study, Acorda is working on expanding Ampyra’s label into other indications. Ampyra is currently in a proof-of-concept study in adults with cerebral palsy – initial results should be out later this year. Besides this, Ampyra’s potential within multiple sclerosis and other disease areas is also being investigated.
Ampyra is currently approved in the US to improve walking in patients with multiple sclerosis (MS). Biogen Idec Inc. (BIIB - Analyst Report) is the company’s exclusive partner to develop and commercialize Ampyra (ex-US trade name: Fampyra) outside the US. Fampyra got conditional approval from the European Commission for the improvement of walking in adult patients with MS with walking disability. Acorda also has a supply agreement with Elan Corporation (ELN - Snapshot Report) for manufacturing Ampyra.
Sales from Ampyra in the first quarter of 2012 were $57.4 million. Acorda reiterated its revenue guidance for Ampyra in the range of $255–$275 million.
First quarter Ampyra revenues remained flat on a sequential basis. Even though January sales of the drug were disappointing, Ampyra sales improved from February. Moreover, Acorda is working on increasing awareness of Ampyra, which should drive sales. We are pleased with the company’s efforts to expand Ampyra’s label. However, it will be a while before data from additional studies will be available. In the meantime, we expect investor focus to remain on the sales ramp-up of the drug.
We currently have a Neutral recommendation on Acorda. The stock carries a Zacks #3 Rank (short-term ‘Hold’ rating).
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