Acorda Therapeutics, Inc.’s ACOR shares were down almost 21.5% after the U.S. District Court for the District of Delaware invalidated four patents of its key multiple sclerosis drug, Ampyra, thereby making way for generic versions of the drug. The company is likely to appeal the ruling.
We remind the investors that Acorda holds five Orange Book listed patents for Ampyra that run up to 2027.
The court upheld one patent for the extended-release (tablets, 10 mg) formulation of the drug, which is set to expire in Jul 2018.
The four U.S. patents invalidated include 8,663,685 (the ‘685 patent), 8,440,703 (the ‘703 patent), 8,354,437 (the ‘437 patent) and 8,007,826 (the ‘826 patent). The patent that was upheld is 5,540,938 (the ‘938 patent).
However, Acorda’s shares have outperformed the Zacks classified Medical-Biomed/Genetics industry so far this year. Shares of the company gained 11.8% while the industry registered an increase of 3.9%.
We note that Acorda is facing patent challenges for Ampyra is the U.S. A total of 10 generic drug manufacturers have submitted abbreviated new drug applications (ANDA) to the FDA, seeking marketing approval for generic versions of Amypra. In 2015 and 2016, Acorda reached settlement agreements with six of the generic companies, including Allergan plc AGN. The patent infringement case against Mylan N.V. MYL, however, is still proceeding in Delaware alongside cases against other ANDA filers.
Ampyra is Acorda’s flagship product, which is currently approved in the U.S. for the improvement of walking in multiple sclerosis patients. It is available outside the U.S. under the trade name Fampyra. The drug registered sales of $492.8 million in 2016, reflecting an increase of 12.8%. Acorda has a licensing agreement with Biogen BIIB for marketing Fampyra outside the U.S.
However, in Nov 2016, Acorda announced that it is discontinuing development of Ampyra for an expanded indication of post-stroke walking difficulties (PSWD).
Zacks Rank
Acorda currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.
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