ROCKVILLE, Md., Nov. 1, 2016 /PRNewswire/ -- TissueGene, Inc. (TGI), a Maryland-based regenerative medicine company, today announced an exclusive licensing and development agreement between Mitsubishi Tanabe Pharma Corporation of Japan (4508:JP TOKYO) and TissueGene's Asia licensee, Kolon Life Science of Korea (102940:KS KOSDAQ). The agreement between the two companies focuses on the development and commercialization of Invossa™, the world's first cell-mediated gene therapy for degenerative osteoarthritis for the Japanese market. Market forecasts predict that the number of osteoarthritis patients in Japan aged 40 and older amounts to more than 25 million and is expected to accelerate with the aging population. Under the terms of the agreement, Mitsubishi Tanabe will pay an upfront payment of approximately $24 Million plus additional payments of up to approximately $410 Million upon achievement of certain development, regulatory and commercial milestones, as well as a double-digit sales royalty. The deal amount announced today represents the largest single-territory deal on record for Korea. Invossa™ is a first-in-class osteoarthritis drug designed to conveniently and effectively treat osteoarthritis of the knee through a single intra-articular injection. Clinical trials completed in Korea and on-going trials in the US have demonstrated pain relief, increased mobility, and improvements in joint structure - offering substantial convenience for osteoarthritis patients who would otherwise be in need of surgery. TissueGene has completed U.S. Phase 2 trials of Invossa™ and received a Special Protocol Assessment ("SPA") designation for Phase 3 trials scheduled to begin in the second quarter of 2017. The US Phase 3 will aim for approval from the US Food and Drug Administration (FDA) as the first disease-modifying osteoarthritis drug (DMOAD). Additional Information can be found at the NIH registry, www.clinicaltrials.gov. Upon completion of its clinical trials in Korea in July of this year, which successfully verified the safety and efficacy of Invossa™, Kolon Life Science filed for a biologics license application with the Korea Ministry of Food and Drug Safety (MFDS). Similarly, Mitsubishi Tanabe will proceed with Japanese clinical trials and regulatory filings and Kolon Life Science will be responsible for manufacturing activities.