South Korea’s Ministry of Food and Drug Safety (MFDS) has approved TissueGene’s Invossa (TissueGene-C) for the treatment of Kellgren-Lawrence Grade 3 knee osteoarthritis (OA).

OA is a slowly progressive joint disease and a major cause of disability and pain among the elderly, second only to cardiovascular disease. The OA market is largely genericised and ample need exists for the availability of a biologic therapy or a disease-modifying OA drug (DMOAD), as current treatments focus on symptom management.

MFDS did not acknowledge Invossa’s effects as a DMOAD, but showing a disease-modifying effect can take years of follow-up data to illustrate and requires sensitive measuring tools. With that in mind, the approval of Invossa in Korea marks a pivotal milestone in the quest for a DMOAD and a first step for Invossa’s global launch strategy.

Invossa comprises a fixed-ratio mixture of non-transduced allogeneic human chondrocytes and allogeneic human chondrocytes expressing transforming growth factor beta 1 (TGF-β1). TGF-β1-stimulated chondrocytes play a critical role in the formation and maintenance of articular cartilage. By utilising this pathway, Invossa has the potential to stimulate the regeneration of joint cartilage. Encouragingly, Invossa reduced the symptoms of OA patients by 84% and 88% in Korea-based Phase III trials and a US-based Phase II trial, respectively, with reported improvements of symptoms lasting for up to two years.

Given this encouraging data, TissueGene has entered into a number of partnerships to help facilitate the commercialisation of its lead asset. The company has licensed intellectual property rights for the development and commercialisation of Invossa in Asia to Kolon Life Science (KLS). In April 2017, Mundipharma announced a strategic partnership with KLS to market Invossa in Korea. Under the partnership, Mundipharma will be responsible for marketing and distributing Invossa to hospitals in Korea, while KLS targets the outpatient general practitioner market.

In November 2016, KLS partnered with Mitsubishi Tanabe Pharma to develop and commercialise Invossa in Japan. Under the agreement, Mitsubishi Tanabe proceeded with Japanese clinical trials and regulatory filings, while KLS was responsible for manufacturing activities. Mitsubishi Tanabe already had expertise in the successful commercialisation of Johnson & Johnson’s rheumatoid arthritis drug Remicade (infliximab) and has the potential to position Invossa for success in the Japanese market.

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By GlobalData

TissueGene holds an agreement with the US Food and Drug Administration (FDA) regarding a special protocol assessment on the design, endpoints, and statistical analysis plan for a US Phase III clinical trial that initiated in June 2017. TissueGene received a $750,000 clinical grant from the Maryland Technology Development Corporation via the Maryland Stem Cell Research Fund for the assessment. The grant will be used to fund a component of the US Phase III clinical trial.

The approval of Invossa for the Korean market is likely to initiate a ripple effect across the major markets. GlobalData believes that if it becomes approved in the US and Japan as a disease-modifying therapy, Invossa has the potential to dominate the OA market as a first-in-class DMOAD and to hold global market exclusivity for the foreseeable future, as long as a strong market access strategy is ensured in each of these markets.