Under the terms of the agreement, Vicore will receive an upfront payment of $10 million and is entitled to commercial milestone payments up to $275 million.
As a result, Nippon Shinyaku will be operationally and financially responsible for the development of C21 in Japan and will contribute Japanese patients and sites to the global late-stage development of C21 at its expense.
Ahmed Mousa, CEO of Vicore, said: “This partnership is an important milestone in the development of C21. Nippon Shinyaku is an ideal partner that brings expertise in rare disease together with a strong track record of successfully partnering with leading companies to bring innovative treatments to the Japanese market. We look forward to working with the Nippon Shinyaku team and leveraging their expertise to successfully develop and commercialize this product in Japan.”
C21 is an oral therapy being developed for the treatment of IPF and has been granted orphan drug designation by the U.S. Food and Drug Administration and European Medicines Agency.
In Vicore’s phase 2a study, C21 demonstrated potential by stabilizing and improving lung function in previously untreated individuals with IPF, with a further phase 2b trial also planned for the first half of this year.
Although IPF affects approximately 34 000 patients in Japan, treatment options are very limited, with Toru Nakai, president of Nippon Shinyaku, describing IPF as a disease with a ‘high unmet medical need’.
“I am delighted to enter into an agreement with Vicore to develop this extremely promising therapy for the Japanese market. C21 will be an important addition to the Nippon Shinyaku portfolio of therapies for rare diseases,” he added.
Vicore will retain all rights to develop and commercialize C21 in the rest of the world.