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Biogen licenses Mitsubishi’s MT-1303 for autoimmune diseases
October 2015
by Mel J. Yeates  |  Email the author
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CAMBRIDGE, Mass.—Biogen has announced an agreement to exclusively license MT-1303, a late stage experimental medicine with potential in multiple autoimmune indications, from Mitsubishi Tanabe Pharma Corp. (MTPC). MT-1303 is an oral compound that targets the sphingosine-1-phosphate (S1P) receptor.
 
According to MTPC’s website, MT-1303 is an S1P receptor functional antagonist, and by inhibiting the receptor function of the S1P receptor on the lymphocyte, it keeps lymphocytes sequestered in the lymph nodes to prevent them from contributing to autoimmune reactions. Due to this mechanism, this compound may be potentially effective for various autoimmune diseases. MTPC is currently conducting clinical trials for MT-1303 for multiple sclerosis, psoriasis, Crohn’s disease and systemic lupus erythematosus in Europe and Japan. The compound has also obtained results suggesting a profile possibly safer than that of the existing S1P receptor functional antagonists.
 
“Based on compelling efficacy and safety data, we believe that MT-1303 could be a best-in-class S1P modulator,” said Dr. Alfred Sandrock, group senior vice president and chief medical officer at Biogen. “There is a great need for effective oral therapies for the treatment of inflammatory bowel disease and other autoimmune indications, and we are excited to strengthen our late-stage pipeline with this next-generation oral investigational therapy.”
 
MT-1303 has completed a successful Phase 2 clinical trial for multiple sclerosis, and Biogen is evaluating a rapid development program in this indication. The company will also investigate indications in inflammatory bowel disease. Biogen will initiate a clinical trial in ulcerative colitis and may advance an existing program in Crohn’s disease to Phase 3.
 
Dr. Kobayashi Tamaki, board director and managing executive officer of MTPC, tells DDNews that the Phase 2 trial of MT-1303 for multiple sclerosis obtained excellent results, both in efficacy and safety. After using the effective dose, no bradycardia was observed that led to clinical concern.
 
Under the terms of the agreement, Biogen will receive worldwide rights to MT-1303, excluding Asia. Biogen will be responsible for global commercialization and also cover development costs outside of Asian territories. MTPC will receive an upfront payment of $60 million from Biogen and may receive up to $484 million in additional milestone payments for multiple indications and territories. MTPC has the right to participate in Biogen’s global clinical trials and has an option to co-promote non-MS indications in the United States. The transaction is expected to close in the fourth calendar quarter of this year.
 
According to Zacks Investment Research, adding a S1P receptor modulator to the pipeline makes sense for Biogen, which has a strong presence in the multiple sclerosis market. The successful development of MT-1303 would also give Biogen the opportunity to diversify into the ulcerative colitis and Crohn’s disease market. However, MT-1303 is not the only S1P receptor modulator in development. In fact, MT-1303 is a few years behind Celgene Corp.’s ozanimod, which is currently in late-stage development for ulcerative colitis (data expected in 2018) and relapsing multiple sclerosis (data due in the first half of 2017). Ozanimod could well become the first S1P receptor modulator to gain approval for inflammatory bowel diseases. Ozanimod could also have an advantage over existing treatments if it is able to maintain its previously demonstrated cardiac, hepatotoxicity and lymphocyte recovery profile.
 
In other recent Mitsubishi Tanabe Pharma news, the company recently completed a deal with Regeneron Pharmaceuticals Inc. to acquire exclusive development and commercialization rights for fasinumab in Japan, Korea and other Asian countries, excluding China. Fasinumab is an antibody that specifically binds to nerve growth factor, which is believed to play a role in pain. In a Phase 2 clinical study regarding osteoarthritis in the United States, fasinumab demonstrated the ability to promptly ameliorate moderate-to-severe pain. A Phase 2b/3 study for pain due to osteoarthritis was initiated in mid-2015 in the United States as well. As a result of this agreement, the two companies plan to move ahead with the development of fasinumab in Japan for indications of musculoskeletal pain, specifically osteoarthritis and chronic low back pain.
 
Code: E101515

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