Cobitolimod, a TLR9 agonist, is currently undergoing evaluation in the global phase III programme, known as CONCLUDE, as an innovative therapy for moderate to severe cases of ulcerative colitis
Cobitolimod is part of InDex’s DNA-based ImmunoModulatory Sequence (DIMS) platform. (Credit: Braňo on Unsplash)
InDex Pharmaceuticals Holding has announced the signing of a licensing agreement with Viatris Pharmaceutical Japan (Viatris Japan) for the registration and commercialisation of cobitolimod in Japan, intended for the treatment of ulcerative colitis.
Cobitolimod, a TLR9 agonist, is currently undergoing evaluation in the global phase III programme, known as CONCLUDE, as an innovative therapy for moderate to severe cases of ulcerative colitis.
The agreement, which includes various milestones, holds a value of up to $50m, excluding any royalties. According to the terms of the agreement, Viatris Japan will make an upfront payment of $10m to InDex, acquiring exclusive rights to commercialise cobitolimod in Japan.
Furthermore, InDex may be eligible for additional payments tied to development and sales milestones, amounting to a potential $40m. Viatris Japan will also pay royalties based on a double-digit percentage of net sales in Japan.
InDex will retain responsibility for funding all aspects of development, including the completion of the global phase III programme CONCLUDE, which incorporates a group of Japanese patients in Induction Study 2, as well as a pharmacokinetic study specifically involving Japanese patients, prior to submission.
Viatris Japan, on the other hand, will finance all regulatory and commercialization expenses, as well as any additional studies required exclusively for the Japanese market.
InDex CEO Jenny Sundqvist said: “We are excited to start our collaboration with Viatris Japan with the common goal to register and commercialise 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 maximise our sales potential and bring the benefits of this innovative therapy to patients.”