Seeing broad potential for Mitsubishi Tanabe Pharma Corp.'s oral sphingosine 1-phosphate antagonist MT-1303, Biogen Inc. agreed to pay $60 million up front and up to $484 million in additional milestones for an exclusive license to the phase II program outside Asia. Biogen, which is assessing the candidate as a treatment for multiple sclerosis (MS), ulcerative colitis, Crohn's disease and other disorders, could be looking to the program to help offset more modest than expected growth in Tecfidera (dimethyl fumarate) sales.
The Cambridge, Mass.-based company said that the compound has completed a "successful" phase II study in MS that could form the basis for a "rapid development program," but that efficacy and safety data from the study won't be presented until the European Committee for Treatment and Research in Multiple Sclerosis Congress in Barcelona early next month. Biogen representatives were unavailable for further comment on the program.
In addition to MS, Biogen said it would study applications of MT-1303 in inflammatory bowel diseases, with plans to initiate a trial in ulcerative colitis and possible advancement of an existing program in Crohn's disease to phase III.
MT-1303 inhibits the receptor function of S1P receptor on lymphocytes, keeping them 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," Mitsubishi Tanabe said. The company, which had planned to outlicense MT-1303 from the start, is currently testing it in MS, psoriasis, Crohn's disease and systemic lupus erythematosus in Europe and Japan.
Results to date, MTPC said, suggest a profile possibly safer than that of the existing S1P receptor functional antagonists. "Considering these results, the company decided to seek an alliance to accelerate development of this drug both in Japan and overseas, to launch the drug as soon as possible and to maximize its product value."
Under terms of the deal, expected to close by year-end, Mitsubishi Tanabe has the right to participate in Biogen's global trials and an option to co-promote the therapeutic for non-MS indications in the U.S.
Mitsubishi Tanabe shares (4508:Tokyo) closed at ¥2,153, up 7.5 percent, after Wednesday's trading session.
"We are encouraged that the company has added a relatively late-stage candidate to its pipeline, especially with a relatively de-risked mechanism of action," said Cory Kasimov, an analyst at J.P. Morgan. Kasimov noted that two S1P modulators have already made it to market, including Gilenya (fingolimod, Novartis AG) and Celgene's ozanimod, which the company acquired as part of its $7.2 billion purchase of Receptos Inc. in July. (See BioWorld Today, July 16, 2015.)
Kasimov expects Biogen will continue to add to its pipeline, given "questions around Tecfidera's launch trajectory from here" and recent phase II misses, such as July's news that the neurotrophic protein neublastin failed to meet Biogen's targeted product profile in sciatica. (See BioWorld Today, June 21, 2000.)
Though Biogen's shares (NASDAQ:BIIB) dropped only slightly on news of the acquisition, losing $5.26 to close at $303.48 Wednesday, the news was likely welcome to investors who've been eager to see the company add some potential near-term spark to its portfolio. Despite sales of Tecfidera rising to $883 million during the second quarter of 2015 compared to $700 million in the same quarter last year, Biogen set expectations for modest growth in U.S. sales of the therapy during the balance of 2015 and for continued pressure in Europe, where Tecfidera has faced stiff competition from Aubagio (teriflunomide, Genzyme/Sanofi SA). (See BioWorld Today, July 27, 2015.)
RBC Capital Markets analyst Michael Yee said the licensing deal also "helps diversify [Biogen's] pipeline a bit with more balance and away from the high risk/high reward programs in Alzheimer's," its anti-LINGO-1 MS program, and programs in secondary-progressive multiple sclerosis, spinal muscular atrophy and other areas.
More than 2.3 million people are affected by MS worldwide. The incidence and burden of inflammatory bowel diseases is on a global rise, with reports of increase in both prevalence and incidence, with the majority of cases reported in Western nations.