US biotech firm Biogen Idec (Nasdaq: BIIB) yesterday announced that the US Patent and Trademark Office (USPTO) has granted US Patent No 8,399,514, which offers additional protection for Tecfidera (BG-12, dimethyl fumarate), the company’s much touted oral therapeutic candidate for the treatment of multiple sclerosis (MS).
The patent, which will expire in 2028, covers the dosing regimen of daily administration of 480mg of Tecfidera. Three previously obtained patents will expire between October 2019 and May 2020. This regimen is included in the proposed marketing application for Tecfidera, which is currently under review by the US Food and Drug Administration. The drug is also under review with regulators in the European Union, Australia, Canada and Switzerland.
Cowen & Co analyst Eric Schmidt estimates that Tecfidera could have annual sales of $3.2 billion by 2017. RBC Capital Markets analyst Michael Yee suggested that the additional patent protection could be worth $10 per share to $15 per share or more, although he cautioned that generic drugmakers could challenge the patent, Bloomberg reports. Credit Suisse analysts have a net present value for Tecfidera in the USA of $22.4 per share (17% of total) for Biogen Idec.
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