US-based biotech firm Capricor Therapeutics has entered into a partnership with Nippon Shinyaku Co., a Japanese pharmaceutical company, for the exclusive commercialisation and distribution in Japan of Capricor’s lead asset, CAP-1002, for the treatment of Duchenne muscular dystrophy (DMD), a rare neuromuscular disease with limited treatment options. This follows the exclusive commercialisation and distribution agreement entered into with Nippon Shinyaku in the United States in January 2022.

Under the terms of the agreement, Capricor will receive an upfront payment of $12 million and in addition, Capricor will potentially receive additional development and sales-based milestone payments of up to approximately $89 million and a meaningful, double-digit share of product revenue.

This agreement is similar to the terms of the US agreement with Nippon Shinyaku, in that Capricor will be responsible for clinical development and Nippon Shinyaku will be responsible for the distribution of CAP-1002 in Japan, once approved. Capricor will sell commercial product to Nippon Shinyaku. In addition, Capricor will hold the Marketing Authorisation in Japan, if the product is approved in that territory.

Duchenne muscular dystrophy is a devastating genetic disorder characterised by progressive weakness and chronic inflammation of the skeletal, heart and respiratory muscles.