Acorda Therapeutics, Inc. and Mayo Clinic announced the enrollment of the first patient in a phase I safety study of rHIgM22. rHIgM22, a remyelinating monoclonal antibody, is being evaluated for the treatment of multiple sclerosis (MS). The study will evaluate the safety, tolerability and efficacy of rHIgM22.
Acorda already has a presence in the MS market in the form of Ampyra, which is approved for the improvement of walking in patients suffering from MS. Acorda is currently working on expanding Amypra’s label into additional indications.
The company recently presented encouraging data on Ampyra from two phase II proof-of-concept studies for cerebral palsy and post-stroke deficit. The company plans to discuss further development of Ampyra for the post-stroke deficit indication with the FDA.
Acorda has an agreement with Biogen Idec Inc. (BIIB - Analyst Report) for marketing Ampyra outside the US under the trade name Fampyra. Fampyra is approved in the EU, Canada, Australia, Israel and New Zealand.
According to Acorda, about 400,000 people in the US suffer from MS. In addition, every year approximately 10,000 patients are diagnosed. Moreover, in the EU, approximately 600,000 people have MS.
We remind investors that companies like Biogen and Novartis AG (NVS - Analyst Report) have a strong presence in the MS market. Biogen has MS products like Tysabri and Avonex in its portfolio. The company recently gained approval for Tecfidera, its oral MS treatment. Meanwhile, Novartis’ Gilenya is used for the treatment of relapsing forms of MS.
Presently, Acorda carries a Zacks Rank #3 (Hold). Comparatively, other biopharma stocks like UCB (UCBJF - Snapshot Report) look well positioned with a Zacks Rank #1 (Strong Buy).