- Clinical-stage biopharma company TissueGene announced Tuesday it will sell off licensing rights for its degenerative osteoarthritis drug Invossa to Japan's Mitsubishi Tanabe Pharma.
- The deal, worth up to $434 million, tasks Mitsubishi Tanabe with seeing the drug through clinical trials and regulatory approvals in Japan. TissueGene, whose Korean licensee Kolon Life Sciences successfully pushed for approval of Invossa in that country in July, will take care of the treatment's production.
- Invossa is a cell therapy that produces therapeutic growth factor beta-1 (TGF- ß1) to help rebuild cartilage in the body. The drug recently wrapped up Phase 2 trials in the U.S. and is slated to start Phase 3 in the second quarter of 2017, according to a November 1 TissueGene statement.
Osteoarthritis has become a ballooning problem in Japan. One 2011 study, for example, found knee osteoarthritis in 42.6% of male and 62.4% of female participants aged 40 and over. Applying those numbers to the country's entire population, the illness could affect 25.3 million people.
The deal comes, therefore, at a time when potential patient bases are large and the landscape for treatments is expanding. A May report from ResearchnResearch said that analysts project the global markets for osteoarthritis pain drugs will increase 8.38% annually, on average, until 2020.
Mitsubishi Tanabe isn't the only company racing to offer a treatment in Japan.
In July, San-Diego-based cell therapy developer Cytori Therapeutics carved a spot for itself, getting approval for clinical use of its eponymous therapy in the Tokyo Osteoarthritis Clinic. Not everyone has seen wins, though.
The FDA hit Teva and Regeneron's fasinumab, which the companies are, in part, testing for osteoarthritis pain, with a clinical hold after one patient displayed the joint disease adjudicated antropathy.
Mitsubishi Tanabe has also been an active dealmaker. The company last month collected from Sun Pharma the marketing and manufacturing rights of 14 prescription brands previously owned by Novartis. And in 2013, it dropped $357 million to acquire vaccine developer Medicago Inc.
Moreover, the company has held licensing rights for Johnson & Johnson's arthritis drug Remicade for years.
"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," CEO of Kolon Life Science Woo-Sok Lee said in the November 1 statement. "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."