Kolon Life Science CEO said he would seek an administrative suit against the drug regulator’s decision to nullify the license of Invossa-K, gene therapy for knee osteoarthritis, and dispute the regulator’s allegations against the drugmaker in court.
CEO Lee Woo-sok told reporters on Tuesday that he did not think that the mislabeled 293 cells in Invossa can be a valid reason to cancel the drug license. “If the license gets revoked, we will request the court to stop the execution of the license nullification order and pursue an administrative suit,” Lee said.
|Kolon Life Science CEO Lee Woo-sok speaks during a news conference on the suspension of Invossa sales on April 1.|
On Wednesday, the Ministry of Food and Drug Safety made the final ruling that it would revoke Invossa permit.
Asked why he did not explain further about the company’s alleged manipulation of data at a hearing on June 18, Lee said, “The hearing was not a proper occasion to appeal.” The company would make rebuttals in the court proceedings, he added.
Lee also explained about when exactly the company was aware that the second fluid of Invossa injection contained 293 cells, instead of cartilage-derived cells, and how the company did not know it for over a decade.
According to Lee, when Kolon discussed a licensing-out deal with Mitsubishi Tanabe in 2017, Kolon was seeking to change contract manufacturing organization (CMO) from Wuxi to Lonza because the company failed to produce Invossa for phase-3 trials for three years after manufacturing Invossa for phase-3 studies.
“Unhappy about our plan, Mitsubishi Tanabe demanded six kinds of related data. Among the data that Lonza sent were the result of the Short Tandem Repeat (STR) testing on the first fluid and Lonza’s STR testing on the second fluid, besides the transforming growth factor (TGF)-beta expression test,” Lee said.
As Lonza handled various cell lines, it conducted its STR tests on Invossa even though Kolon TissueGene, Kolon Life Science, and Mitsubishi Tanabe did not request them, Lee went on to say.
He did not pay close attention to the STR testing on the second fluid because it was not a mandatory test, he added. He expressed regret over the “excessive” public criticism on the Invossa issue.
“I’m afraid the public is losing the sense of balance. I apologize for creating the problem. However, this issue needs a debate based on pharmacology and science, but it’s not going in that direction. Rather, we need to discuss why 293 cells cannot be used as an ingredient for a drug,” Lee said.
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