Alkermes net $50 million from Biogen in connection with multiple sclerosis drug BIIB098
June 6, 2018Alkermes has received a $50 million payment from Biogen after it reviewed the preliminary gastrointestinal tolerability data from the ongoing clinical development program for BIIB098 (diroximel fumarate), Alkermes said.
BIIB098 (formerly ALKS 8700) is a novel, oral fumarate in phase 3 development for the treatment of relapsing forms of multiple sclerosis (MS). Alkermes expects to submit a New Drug Application (NDA) for BIIB098 to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2018.
“The clinical data generated from this program underscore the potential value of BIIB098 for patients with multiple sclerosis,” said Richard Pops, Chief Executive Officer at Alkermes. “Our focus remains on completing the registration requirements and preparing the BIIB098 NDA for submission in the fourth quarter of 2018, as we advance this important potential new therapeutic option for patients with MS.”
Substantially all of the payment will be recorded as License Revenue in Alkermes’ financial results for the quarter ending June 30, 2018.
Under the terms of the license and collaboration agreement, Biogen has an exclusive, worldwide license to commercialize BIIB098 and will pay Alkermes a mid-teens percentage royalty on worldwide net sales. Alkermes may also receive a $150 million milestone payment from Biogen upon FDA approval, on or before Dec. 31, 2021, of the NDA for BIIB098.
BIIB098 is currently in phase 3 development for relapsing forms of MS. Alkermes plans to seek approval of BIIB098 under the 505(b)(2) regulatory pathway referencing Biogen’s TECFIDERA (dimethyl fumarate). Alkermes’ registration package for BIIB098 will include pharmacokinetic bridging studies to establish bioequivalence to dimethyl fumarate and data from a two-year safety study known as EVOLVE-MS-1.
