Kolon TissueGene is preparing to launch the osteoarthritis treatment Invossa (TG-C) in the United States by receiving a 60 billion won cash injection from Kolon and bringing an overseas plant online. With legal uncertainties around Invossa resolved, the company is mobilizing all its resources for the new drug launch.
According to the Financial Supervisory Service's electronic disclosure system on the 9th, Kolon TissueGene will carry out a third-party allotment paid-in capital increase to Kolon. The number of shares is 118,040, and the issue price, calculated based on the set criteria, is 508,325 won per share. The payment date is the 24th, and the listing date for the new shares is the 15th of next month. Kolon has put a one-year lockup in place to prevent the sale of the shares.
Kolon TissueGene plans to use the funds secured through the paid-in capital increase for U.S. Food and Drug Administration (FDA) approval and commercialization of Invossa. A Kolon TissueGene official said, "Based on the cash of 80 billion won held at the end of last year, approval is possible," adding, "We are preparing for commercialization in parallel, so the capital increase funds will be used for commercialization."
Production of Invossa will be handled exclusively at Lonza's plant in Singapore. Kolon TissueGene transferred the Invossa technology last year and is currently running manufacturing processes for approval. Once this procedure is completed, the approval process is expected to gain speed.
Kolon TissueGene will also strengthen its board ahead of the Invossa launch. Lee Kyu-ho, Kolon vice chairman and a fourth-generation member of the owner family, is set to become an inside director following a shareholders meeting on the 26th. Lee is the eldest son of honorary chairman Lee Woong-yeol of Kolon Group.
Inside directors are involved in key board decisions such as large-scale investments and hiring. If Lee is registered as an executive director, it could be interpreted as an intention to throw weight behind Invossa going forward. A Kolon TissueGene official said, "Vice Chairman Lee is interested in bio, a future core strategic business for the group."
Kolon TissueGene also plans to newly appoint two outside directors. Jan Van Acker, who served as a board member of the Health Innovation Venture Fund at Merck, and ROBERT YUEN LEE ANG, a board member of the Alliance for Regenerative Medicine in the United States, will be brought in. Their global experience and networks are expected to be utilized in the new drug launch process.
A Kolon TissueGene official said, "As we prepared for Invossa commercialization and more, we searched for specialists and decided to appoint the candidates," adding, "We plan to appoint outside directors in line with the amended Commercial Act."
Invossa had gone through twists and turns for years. In Korea, Invossa was approved as a gene therapy in 2017 and sales began. During a separate clinical trial in the United States in 2019, it became known that the active ingredient differed from what had been reported to the Ministry of Food and Drug Safety. As the active ingredient was found to be kidney-derived cells, not cartilage-derived cells, sales in Korea were suspended and the approval was canceled.
The U.S. Food and Drug Administration approved the resumption of the clinical trial the following year, saying there were no safety issues. Kolon TissueGene changed the name of Invossa to TG-C and continued the trial. Invossa has completed dosing of patients in a phase 3 trial in the United States and is in the follow-up stage. The company plans to announce key results around July and, if there are no particular issues, apply for approval to the FDA in the first quarter of next year.
Given that it takes about a year from filing for approval to launch, the product is expected to be introduced in 2028. If marketing is confirmed, Kolon TissueGene will hold the rights in the United States and Europe, while Kolon Life Science will hold the rights in Korea and Asia.