Salix Announes License Agreement with Mitsubishi Tanabe Pharma to Develop, Commercialize MT-1303

Salix Pharmaceuticals announced its affiliate has entered into an exclusive licensing agreement with Mitsubishi Tanabe Pharma to develop and commercialize MT-1303 (amiselimod), a late-stage oral compound that targets the sphingosine 1-phosphate (S1P) receptor that plays a role in autoimmune diseases, such as Inflammatory Bowel Disease (IBD) and ulcerative colitis.

Approximately 1.6 million Americans currently suffer from IBD and as many as 70,000 new cases of IBD are diagnosed in the United States annually. Of the 1.6 million Americans with IBD, about 907,000 of them have ulcerative colitis. Beyond conventional therapies such as mesalamines, steroids and systemic immunosuppressive agents, IBD can also be managed through the use of antibody-based biologics. While many patients have benefited from these antibody-based therapies, a number of patients do not respond to biologics.

"For patients living with IBD, amiselimod represents an opportunity to develop an oral, non-immunogenic treatment as an alternative to biologics and other available therapies," said Mark McKenna, president, Salix Pharmaceuticals. "Today's announcement reflects Salix's commitment to serving the unmet needs of gastrointestinal patients and to offering health care providers with new treatment options to consider when they are managing patients who suffer from this chronic, life-long condition."

Under the agreement, MTPC grants Bausch Health exclusive rights to develop and commercialize MT-1303 worldwide, except for Japan and certain other countries in Asia, in all fields, excluding neurology, rheumatology and certain rare dermatology diseases, where MTPC retains the rights. Bausch plans to initiate development of MT-1303 in ulcerative colitis. Under the terms of the license, Bausch Health will pay to MTPC a one-time up-front payment, as well as certain development and regulatory-based milestone payments and sales-based royalties.

MT-1303 is a sphingosine-1-phosphate (S1P) receptor functional antagonist and, by inhibiting the receptor function of the lymphocyte sphingosine-1-phosphate (S1P) receptor, retains lymphocytes sequestered in the lymph nodes and prevents them from contributing to autoimmune reactions. Due to this mechanism of action, MT-1303 may potentially be useful for various autoimmune diseases.  Mitsubishi Tanabe Pharma has conducted clinical trials for MT-1303 for multiple sclerosis, psoriasis, Crohn's disease and systemic lupus erythematosus in Europe and in Japan. Affinity to S1P1, S1P4 and S1P5 receptor subtypes, suggests that MT-1303 could potentially have a more pronounced effect on ulcerative colitis related inflammation than compounds with restricted activity on S1P1 receptor subtype exclusively or combined activity on S1P1 and S1P5.

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