Mitsubishi Seeks To Revoke Kolon Gene Therapy Deal But Damage Limited?
Mitsubish Tanabe has sought to cancel the license agreement for Kolon Life Science's Invossa, clouding the South Korean firm’s global ambitions for the allogeneic cell mediated gene therapy. However, analysts don’t anticipate a big hit for Kolon even if the deal falls through given that the cancellation demand is not linked to Invossa’s efficacy.
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In a worst case scenario for the country’s first approved gene therapy, South Korea has cancelled the global-first approval of Kolon Life’s Invossa and asked prosecutors to press criminal charges against the company, which it concluded submitted false data to support approval. The major blow to the company comes as it is already facing lawsuits from patients and investors, and has prompted a broader regulatory overhaul for novel biologic therapies.
Kolon Life Science has reached a sizable license deal with Mundipharma for the development in Japan of the South Korean company’s first-in-class cell and gene therapy for osteoarthritis of the knee, easing uncertainties after an agreement with Mitsubishi Tanabe for the product collapsed last year.
With the removal of an FDA clinical hold, Kolon TissueGene is set to begin a US Phase III trial for Invossa, its first-in-class cell and gene therapy, for osteoarthritis of the knee. The planned study, which is larger and longer than the product's Korean Phase III program, will be under the spotlight as it will determine whether Invossa can be designated as the world's first disease-modifying drug in osteoarthritis, and is being designed accordingly.