Mitsubishi Tanabe Pharma and Salix Pharmaceuticals have entered into an exclusive licensing agreement for MT-1303 (amiselimod), a therapeutic agent for autoimmune diseases including inflammatory bowel disease (IBD) and ulcerative colitis.
Salix’s shares are all owned by Bausch Health Companies.
MT-1303 (amiselimod) is a selective sphingosine 1-phosphate (S1P) receptor antagonist. S1P receptors are proteins expressed on the surface of lymphocytes, a type of immune cell. The oral therapy prevents lymphocytes from exiting the lymph nodes and traveling to other tissues, thus controlling the exacerbated autoimmune response and reducing inflammation.
Bausch now has exclusive rights to develop and commercialize MT-1303 around the world, except for Japan and other Asian countries. Mitsubishi will continue to develop the therapy for neurological, rheumatological and certain rare dermatological indications, but MT-1303’s development for any other field is the responsibility of Bausch.
According to the licensing agreement, Mitsubishi will receive a one-time upfront payment, development- and regulatory-based milestone payments and sales-based royalties from Bausch.
Inflammatory bowel diseases (IBD), which include ulcerative colitis and Crohn’s disease, are chronic, disabling, and progressive disorders that require lifelong treatment.
Treatment options for IBD aim to stop inflammation and include non-biological therapies, such as steroids, and biological ones, such as anti-tumor necrosis factor (TNF) agents. Using the latter has improved patients’ quality of life without the need for surgery and hospitalization. However, and like any other treatment, these therapies have not been effective in all patients, and subjects who initially responded to treatment have also lost their responsiveness over time. Therefore, there’s still a need for new treatment approaches.
“For patients living with IBD, [MT-1303] represents an opportunity to develop an oral, non-immunogenic treatment as an alternative to biologics and other available therapies,” Mark McKenna, president of Salix Pharmaceuticals, said in a news release.
“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, lifelong condition.”
Bausch is planning to initiate development of MT-1303 in ulcerative colitis, an inflammatory disease that affects the large bowel (colon and rectum).