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Trials & Filings

Alkermes Receives MMF Patent

Expects to begin trials of MS prodrug in mid-2014

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application 14/032,736, entitled “Prodrugs of fumarates and their use in treating various diseases,” to Alkermes. The allowed composition-of-matter claims will cover Alkermes’ MMF prodrug, ALKS 8700, a proprietary, small-molecule prodrug of monomethyl fumarate (MMF) for the treatment of multiple sclerosis. The Notice of Allowance resulted from a prioritized examination granted by the USPTO, and the allowed claims are directed toward a novel MMF prodrug that is designed to rapidly and efficiently convert to MMF in the body.

Alkermes plans to file an IND application with the FDA and initiate a Phase I study of ALKS 8700 by mid-2014. The patent is expected to be issued within the next few months and to expire no earlier than 2033. A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application.

ALKS 8700 is designed to offer differentiated dosing and tolerability, as compared to the currently marketed dimethyl fumarate prodrug, Biogen Idec’s Tecfidera.

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