Biogen Idec (BIIB) recently announced additional patent protection for its oral multiple sclerosis candidate, Tecfidera (dimethyl fumarate). The company said that the US Patent and Trademark Office (:USPTO) has granted US Patent No. 8,399,514 to Tecfidera.
The recently issued patent, covering the daily dosing regimen of Tecfidera 480 mg, is set to expire in 2028. We note that sometime back, the European Patent Office had said that Biogen’s application for a patent covering the same dosing regimen of Tecfidera is allowable. This patent will also expire in 2028, once it is granted.
Tecfidera is currently under FDA review with a response expected shortly. The new drug application (:NDA) for Tecfidera was based on data from the phase III DEFINE and CONFIRM studies which showed that treatment with Tecfidera led to a significant reduction in disease activity in multiple sclerosis patients. Moreover, the candidate had a favorable safety and tolerability profile.
Biogen is the market leader in therapies for the treatment of multiple sclerosis. The company’s key products include Avonex and Tysabri. Biogen has been working on strengthening its position in the multiple sclerosis market. We believe Tecfidera could become a leader in the oral multiple sclerosis market once launched.
Biogen currently carries a Zacks Rank #2 (Buy). While Avonex and Tysabri should continue contributing significantly to sales, Tecfidera should help drive long-term growth. We are also encouraged by the company’s progress with its hemophilia candidates.Read the Full Research Report on XOMA
More From Zacks.com
- Biogen Idec
- multiple sclerosis
- European Patent Office
- US Patent and Trademark Office