DUBLIN, June 6, 2018 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) today announced it has received a $50 million payment from Biogen. This payment follows Biogen’s review of preliminary gastrointestinal tolerability data from the ongoing clinical development program for BIIB098 (diroximel fumarate). 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.
About the EVOLVE-MS Clinical Development Program
The key components of the EVOLVE-MS (Endeavoring to Advance Treatment for Patients Living with Multiple Sclerosis) clinical development program of BIIB098 include a two-year safety study and pharmacokinetic bridging studies comparing BIIB098 and dimethyl fumarate.
BIIB098 (diroximel fumarate) is an oral, novel fumarate candidate in development for the treatment of relapsing forms of multiple sclerosis (MS). BIIB098 is designed to rapidly and efficiently convert to monomethyl fumarate in the body and to potentially offer differentiated features as compared to dimethyl fumarate.
About Multiple Sclerosis
Multiple sclerosis (MS) is an unpredictable, often disabling disease of the central nervous system (CNS), which interrupts the flow of information within the brain, and between the brain and body.1 MS symptoms can vary over time and from person to person. Symptoms may include extreme fatigue, impaired vision, problems with balance and walking, numbness or pain and other sensory changes, bladder and bowel symptoms, tremors, problems with memory and concentration and mood changes, among others.1Approximately 400,000 individuals in the U.S. and 2.5 million people worldwide have MS, and most are diagnosed between the ages of 15 and 50.2
About Alkermes plc
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.