Swedish firm InDex Pharmaceuticals Holding AB has announced that a license agreement has been signed with Viatris Pharmaceutical Japan Inc. to register and commercialise cobitolimod in Japan for the treatment of ulcerative colitis.

Cobitolimod is a TLR9 agonist which is being evaluated in the global phase III programme CONCLUDE, as a novel treatment for moderate to severe ulcerative colitis. The agreement including milestones is worth up to $50 million, excluding royalties.

Under the terms of the agreement, Viatris Japan will pay InDex an upfront fee of $10 million for the exclusive rights to commercialise cobitolimod in Japan. In addition, InDex is eligible to receive development and sales milestone payments of up to $40 million. Viatris Japan will also pay up to double-digit percentage royalties based on its net sales for the product in Japan.

InDex will continue to fund all development which incorporates the completion of the global phase III-program CONCLUDE, including a cohort of Japanese patients in Induction Study 2 and a PK study in Japanese patients prior to filing. Viatris Japan will fund all regulatory and commercialization expenses, as well as any additional Japanese-specific studies required in Japan.