The deal covers the Asia Pacific region, the Middle East and Africa except for South Korea, China, Hong Kong, Macao and Taiwan. Juniper Biologics will be responsible for developing and commercializing TG-C LD (low dose) for medical professionals and hospitals.
"We are committed to providing innovative treatments to treat osteoarthritis of the knee through the regeneration of cartilage and we believe this innovative investigational treatment will bring relief to millions of patients across the region," Juniper Biologics CEO Raman Singh said in a statement on April 13.
Kolon TissueGene, the U.S subsidiary of Kolon Life Science, has completed phase 2 clinical trials in the United States, with initial data demonstrating sustained pain relief and mobility improvement following a single injection in the knee joint, for possibly up to two years. Phase 3 clinical trials are underway.
"This would be a validation of our technology and its market value," said Kolon Life Science CEO Lee Woo-sok. TG-C is a novel cell and gene therapy targeting knee osteoarthritis through a single intra-articular injection.
Patient recruitment for clinical trials was suspended due to product identity concerns in 2019 after Kolon TissueGene found during U.S. clinical trials that a key ingredient was different from that described in the data submitted at the time of permission in South Korea.
Kolon TissueGene avoided stock market delisting at home by receiving a one-year grace period from Korea Exchange after the U.S. Food and Drug Administration sent a letter in April 2020 that a temporary ban on clinical trials has been lifted.
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