Kadmon And Meiji Announce Collaboration To Develop And Commercialize KD025 In Japan

Kadmon Holdings, Inc., a New York-based biopharmaceutical company, and Meiji Seika Pharma Co., Ltd, a Tokyo-based wholly owned subsidiary of Meiji Holdings Co., Ltd., today announced that the companies have entered into a strategic collaboration to form a joint venture to exclusively develop and commercialize KD025 in Japan and certain other Asian countries.

Under the terms of the transaction agreements, Kadmon will receive payments which could exceed $29.0M, resulting from various potential establishment, development, regulatory and commercial milestones. In addition, Kadmon is eligible to receive double-digit percentage royalty payments on sales of KD025 in the territory.

KD025, Kadmon’s ROCK2 inhibitor, is being studied in a pivotal clinical trial in the United States for the treatment of chronic graft-versus-host disease (cGVHD). In October 2018, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to KD025 for the treatment of cGVHD after two or more lines of systemic therapy.

The joint venture, Romeck Pharma, LLC, is domiciled in Japan with shared oversight between Kadmon and Meiji.

“The KD025 data generated to date provides a clear rationale for our desire to partner with Kadmon to develop KD025 to potentially treat a range of inflammatory and fibrotic diseases for Japanese and other Asian patients,” said Daikichiro Kobayashi, President and Representative Director of Meiji. “Kadmon is an exciting company with whom we share the same ethical and innovative vision to develop and deliver important medicines to critically ill patients, and we are highly motivated to seek fast-track regulatory approval of KD025 in our region.”

“We are pleased to partner with Meiji, a globally respected organization who has commercialized pharmaceuticals in Japan and Asia for over 70 years,” said Harlan W. Waksal, M.D., President and CEO of Kadmon. “KD025 is a unique drug candidate with potential to treat many inflammatory and fibrotic diseases, and we hope that this joint venture will, together with our recently announced collaboration with BioNova in China, accelerate access to this drug for patients across East and Southeast Asia.”

“Meiji is an ideal partner for the Japanese region: their drug development experience and commitment to advancing KD025 expeditiously gives us great confidence in this joint venture to bring KD025 to additional patients in need,” added Faical Miyara, Ph.D., Senior Vice President, Business Development of Kadmon.