India Pharma Outlook Team | Monday, 12 February 2024
Vicore Pharma Holding AB, an innovative clinical-stage pharmaceutical company unlocking the potential of a new class of drug candidates, angiotensin II type 2 receptor agonists (ATRAGs), has entered into an exclusive licensing agreement with Nippon Shinyaku Co. Ltd., a leading Japanese pharmaceutical company, to develop and commercialize Vicore's drug candidate C21 in Japan.
Under the terms of the agreement, Vicore will receive an upfront payment of USD 10 million and is entitled to potential development and commercial milestone payments up to a total of USD 275 million. Vicore is eligible to receive tiered royalties extending into the low 20s based on annual net sales of C21 in Japan. Nippon Shinyaku holds the exclusive right to develop and commercialize C21 in Japan, focusing initially on treating idiopathic pulmonary fibrosis (IPF). Nippon Shinyaku will be operationally and financially responsible for developing C21 in Japan and will contribute Japanese patients and sites to the global late-stage development of C21 at its expense. Vicore retains all rights to C21 in the rest of the world.
C21 is an oral therapy developed for treating IPF and has been granted orphan drug designation by the US Food and Drug Administration and the European Medicines Agency. Although IPF affects approximately 34,000 patients in Japan, treatment options are limited. In the phase 2a AIR study, C21 demonstrated transformative potential by safely and effectively stabilizing or improving lung function in previously untreated individuals with IPF. A global phase 2b ASPIRE study will begin in the first half of this year.
"This partnership is an important milestone in the development of C21", said Ahmed Mousa, CEO of Vicore. "Nippon Shinyaku is an ideal partner with expertise in rare diseases and 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 develop and commercialize this product successfully in Japan.