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"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
Substantially all of the payment will be recorded as License Revenue in
Under the terms of the license and collaboration agreement, Biogen has an exclusive, worldwide license to commercialize BIIB098 and will pay
BIIB098 is currently in phase 3 development for relapsing forms of MS.
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
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the continued clinical development and the potential therapeutic and commercial value of BIIB098 for the treatment of relapsing forms of MS, the regulatory strategy for filing of an NDA for BIIB098 and the adequacy of the EVOLVE-MS development program for BIIB098 to serve as the basis for an NDA, the timing of the submission of an NDA to the
TECFIDERA® is a registered trademark of Biogen Inc.
1 National Multiple Sclerosis Society. Multiple Sclerosis: Just the Facts. Accessed from http://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/Brochure-Just-the-Facts.pdf on June 5, 2018.
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