Kolon Ends One Asian Invossa Contract, But Hopes To Keep Others
Korean firm Kolon terminates one Asia supply contract for Invossa, but appears hopeful it can maintain other remaining deals as it counts on resuming US clinical trials with the troubled gene therapy.
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Kolon TissueGene is facing delisting in South Korea after the recent revocation of approval of gene therapy Invossa, which could fuel legal action from shareholders. The company still hopes to resume Invossa trials in the US by submitting additional data demanded by the FDA.
The planned merger between Genexine and ToolGen, which was poised to create a major Korean biotech entity, has collapsed amid recent generally weak investor sentiment over the sector. But the two sides will maintain their collaborations for new drug development going forward, with a focus on gene and cell therapies.
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.