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–– Novel, Oral, Fumarate Therapy Intended to Provide a Differentiated Gastrointestinal Tolerability Profile ––
–– Biogen Brings Multiple Sclerosis Expertise to Commercialization of ALKS 8700 ––
–– New Drug Application Anticipated for Submission in 2018 ––
“This partnership is further evidence of Biogen’s ongoing commitment to
multiple sclerosis and builds upon our deep experience in
neuroscience and particularly in MS,” stated
“This collaboration has the potential to provide important benefits to
patients with multiple sclerosis and immediately increases the value of
ALKS 8700 to Alkermes,” said Richard Pops, Chief Executive Officer at
Under the terms of the agreement, Biogen will receive an exclusive,
worldwide license to commercialize ALKS 8700 and will pay
This collaboration aligns the interests of
ALKS 8700 is currently in Phase 3 development for MS.
Also, currently underway is a head-to-head study (EVOLVE-MS-2) evaluating the GI tolerability of ALKS 8700 compared to TECFIDERA. Initial data from EVOLVE-MS-2 are expected in the first half of 2018.
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 ALKS 8700 include a two-year safety study and pharmacokinetic bridging studies comparing ALKS 8700 and TECFIDERA. In addition, the program includes an elective head-to-head study comparing the GI tolerability of ALKS 8700 and TECFIDERA.
About ALKS 8700
ALKS 8700 is an oral, novel and proprietary monomethyl fumarate (MMF) prodrug candidate in development for the treatment of relapsing forms of multiple sclerosis (MS). ALKS 8700 is designed to rapidly and efficiently convert to MMF in the body and to offer differentiated features as compared to the currently marketed dimethyl fumarate, TECFIDERA®.
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
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen
discovers, develops and delivers worldwide innovative therapies for
people living with serious neurological and neurodegenerative diseases.
Founded in 1978 as one of the world’s first global biotechnology
We routinely post information that may be important to investors on our
website at www.biogen.com.
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Biogen Safe Harbor
This press release contains forward-looking statements, made pursuant to
the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995, including statements relating to the potential benefits and
results, including financial and operating results, that may be achieved
through Biogen’s license agreement with
These statements involve risks and uncertainties that could cause actual
results to differ materially from those reflected in such statements,
including, without limitation: uncertainty as to whether the anticipated
benefits and potential of Biogen’s license agreement with
Alkermes 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 expansion of Alkermes’
portfolio of medicines in psychiatry, the continued clinical development
and the potential therapeutic and commercial value of ALKS 8700 for the
treatment of relapsing forms of MS, the number of patients enrolled in
the ALKS 8700 Phase 3 studies, the timing of expected initial data from
EVOLVE-MS-2, the regulatory strategy for filing of an NDA for ALKS 8700
and the adequacy of the EVOLVE-MS development program for ALKS 8700 to
serve as the basis for an NDA, the timing of the submission of an NDA to
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 Nov. 27, 2017.
Matt Calistri, +1-781-464-2442
Matt Fearer, +1-781-464-3260
Sandy Coombs, +1-781-609-6377
Eva Stroynowski +1-781-609-6823
Jennifer Snyder, +1-781-609-6166