Over the past few months, we have become increasingly confident Acorda Pharmaceuticals' (NASDAQ:ACOR) application for Fampridine-SR looks strong -- from a clinical data standpoint. The application contains data from a comprehensive development program assessing the safety and efficacy of Fampridine-SR, including two phase III trials that involved 540 people with MS, and were conducted under Special Protocol Assessments (SPAs) from the FDA.
The safety and efficacy profile of Fampridine-SR was consistent across phase II and phase III trials. In total, the NDA filing included more that 50 clinical studies and over 1,200 patient-years. Additionally, more than 450 people are currently enrolled in Fampridine-SR extension trials, with treatment duration ranging from seven months to almost five year. We believe the odds favor approval in October 2009.
In the meantime, Acorda is preparing for the launch in the U.S. by doubling the sales force currently promoting Zanaflex, to 120 - 130 representatives by the end of the year. Approval in October 2009 is only a month or two ahead of management's original thinking prior to the RFT delay, so we believe that timelines at Acorda for ramping the commercial infrastructure are well with reasonable expectations.
Management also remains in active discussions with potential European partners for Fampridine-SR. We just recently learned that the product is eligible to be filed under the EU's centralized procedure, and will have 10 years of exclusivity post-approval. A European partnership has the potential to bring in significant upfront cash and backend milestones and royalties to Acorda. This is a major catalyst for the shares potentially later this summer or fall ahead of U.S. approval.
Fampridine-SR remains one of the more interesting late-stage biotechnology products and has multi-hundred million dollar potential, in our view. We have been waiting for an opportunity to recommend the shares. We encourage investors to pick up Acorda at today's price based on our belief that the future looks very bright for the firm, despite the minor setback on the filing.
One wildcard event that could send Acorda's shares soaring would be an acquisition by a larger player in the MS space. The three names that come to mind are Biogen (NASDAQ:BIIB), Novartis (NYSE:NVS) and Sanofi-Aventis (NYSE:SNY). In the meantime, we see $30 as a near-term fair-value.