TissueGene licensee Kolon Life Science (KSDQ:102940) of Korea said this week that it inked a deal with Japan’s Mitsubishi Tanabe Pharma Corp. (TYO:4508) to develop and commercialize Kolon’s Invossa, the 1st cell-mediated gene therapy injection for degenerative osteoarthritis for the Japanese market.
The deal represents the largest single-territory deal on record for Korea, according to Kolon Life Science. According to the agreement, Mitsubishi Tanabe will pay $24 million up front, plus additional payments of up to $410 million pending development, regulatory and commercial milestones, as well as a double-digit sales royalty.
Invossa is an allogenic, cell-mediated gene therapy delivered through a single intra-articular injection to treat osteoarthritis of the knee. The therapy has completed Phase II clinical trials in the U.S., and TissueGene recently reached an agreement with the FDA regarding a Special Protocol Assessment for a Phase III clinical trial, scheduled to begin in the 2nd quarter of 2017.
Kolon completed clinical trials in Korea in July and filed for a biologics license application with the Korea Ministry of Food & Drug Safety. Mitsubishi Tanabe will move forward with clinical trials and regulatory filings in Japan, while Kolon will be responsible for manufacturing.
“This license agreement for Invossa is significant in that it marks the first key step for global recognition of Korea’s first gene-therapy drug,” Kolon Life Science CEO Woo-Sok Lee said in prepared remarks. “Mitsubishi Tanabe already has expertise and experience in the successful commercialization of Johnson and Johnson’s rheumatoid arthritis drug Remicade which should boost the potential success of Invossa in the Japanese market.”