InDex Pharmaceuticals Holding AB today announced that a license agreement has been signed with Viatris Pharmaceutical Japan Inc.to register and commercialize cobitolimod in Japan for the treatment of ulcerative colitis. Cobitolimod is a TLR9 agonist which is being evaluated in the global phase III program CONCLUDE, as a novel treatment for moderate to severe ulcerative colitis. The agreement including milestones is worth up to USD$50m, excluding royalties.

Under the terms of the agreement, Viatris Japan will pay InDex an upfront fee of USD 10 million for the exclusive rights to commercialize cobitolimod in Japan. In addition, InDex is eligible to receive development and sales milestone payments of up to USD 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.

Jenny Sundqvist, CEO of InDex, says, “We are excited to start our collaboration with Viatris Japan with the common goal to register and commercialize cobitolimod for the Japanese market. Viatris Japan shares our view of how best to position cobitolimod for the treatment of moderate to severe ulcerative colitis in the Japanese market. Their experience and presence in the local gastrointestinal segment will ensure that we maximize our sales potential and bring the benefits of this innovative therapy to patients.”

 

Source:indexpharma.com

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