MS: Alkermes bags US$50m milestone from Biogen

Gastrointestinal (GI) events are normally increased in the first months of administration with Biogen’s FDA-approved , delayed-release dimethyl fumarate (DMF) but rarely lead to discontinuation of treatment. The milestone payment by Biogen suggests that long-term safety of oral BIIB098, a novel prodrug of monomethyl fumarate to treat relapsing forms of MS, was superior to Biogen’s dimethylfumarate (DMF), which transiently causes GI events in up to 4% of patients (vs 1% under placebo), most often during the first month of administration.

In the pivotal Phase III, safety and pharmacokinetics of BIIB098 (formerly ALKS 8700) were compared vs those of DMF over 24 months.  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. Alkermes plans to seek approval of BIIB098 under the 505(b)(2) regulatory pathway referencing Biogen’s Tecfidera (dimethyl fumarate). BIIB098 is designed to rapidly and efficiently convert to monomethyl fumarate, a metabolite of DMF, in the body and to potentially offer differentiated features as compared to dimethyl fumarate. 

At the beginning of May, Alkermes had reported efficacy data of BIIB098. The annualized relapse rate at a median follow-up of 0.93 patient-years (total, 497.1 patient-years) in 578 patients enrolled to date in the 2-year, open-label study was just 0.16,  the company reported the annual meeting of the American Academy of Neurology. Furthermore, a statistically significant 80% reduction from baseline was seen in the number of gadolinium-enhancing lesions in 374 patients who completed a 1-year MRI assessment (from a mean of 1.5 to 0.3).

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 US$150m milestone payment from Biogen upon FDA approval, on or before Dec. 31, 2021, of the NDA for BIIB098.