Policy & Regulation
InDex Pharmaceuticals signs license agreement with Viatris Japan
1 June 2023 -

InDex Pharmaceuticals Holding AB (publ), a Sweden-based pharmaceutical development company, announced on Wednesday that it has entered into a license agreement with Viatris Pharmaceutical Japan Inc., to register and commercialise cobitolimod in Japan, intended for the treatment of ulcerative colitis.

Cobitolimod, a TLR9 agonist, is being assessed in the global phase III program CONCLUDE, as a novel treatment for moderate to severe ulcerative colitis.

Under the terms of the agreement, Viatris Japan will pay InDex an upfront fee of USD10m for the exclusive rights to commercialise cobitolimod in Japan. In addition, InDex is eligible to receive development and sales milestone payments of up to USD40m. 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.