Biogen and Alkermes got approval from USFDA for Vumerity, a novel oral fumarate with a distinct chemical structure, for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
As noted in the press release from Wednesday, Biogen holds the exclusive, worldwide license to commercialize Vumerity and intends to make it available in the United States in the near future.
Alfred Sandrock, Jr., executive vice president, research and development, and chief medical officer at Biogen said that Vumerity is a novel fumarate that offers the well-characterized efficacy of Tecfidera (dimethyl fumarate) and has been studied for improved patient-reported gastrointestinal tolerability.
The companies said in the announcement that the FDA approval of Vumerity was based on a New Drug Application (NDA) which included data from pharmacokinetic bridging studies comparing Vumerity and Tecfidera to establish bioequivalence, and relied, in part, on the FDA’s findings of safety and efficacy for Tecfidera.
Under the terms of the license and collaboration agreement between Biogen and Alkermes, Biogen will pay Alkermes $150 million in connection with the FDA’s approval of Vumerity. Biogen plans to account for this milestone payment as an asset that will be amortized over the expected useful life of the product, the companies said in the press release. Alkermes is also entitled to receive a mid-teens percentage royalty on worldwide net commercial sales of Vumerity, subject, under certain circumstances, to minimum annual payments for the first five years following FDA approval and customary reductions as set forth in the agreement.