Korean Approval Received by Kolon Life Science, TissueGene’s Exclusive Licensee
BioLife Solutions, Inc. (NASDAQ: BLFS), the leading supplier of pre-formulated, clinical grade cell and tissue hypothermic storage and cryopreservation freeze media (“BioLife”), announced on July 13th 2017 that Kolon Life Science, TissueGene’s exclusive licensee for Asia, including Korea, has received marketing approval for Invossa-K Inj., the world’s first cell and gene therapy for degenerative arthritis from the Korea Ministry of Food and Drug Safety (MFDS).The manufactured Invossa cell and gene therapy will be frozen and shipped in BioLife’s CryoStor cell freeze media to extend the shelf life until arrival at the clinic for injection into the patient.
Invossa is a first-in-class cell and gene therapy 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 in the US have demonstrated pain relief, increased mobility, and potentially game-changing improvements in joint structure – offering substantial relief and convenience for osteoarthritis patients who would otherwise be in need of surgery.
In December 2016, BioLife executed a ten year supply agreement with TissueGene to supply clinical grade CryoStor for use in the Invossa manufacturing process. Kolon Life Science filed for a Biologics License Application (BLA) for Invossa-K Inj. with the MFDS in August 2016 based on efficacy results from its Phase III clinical trials conducted at 12 major university hospitals in Korea.