Kolon management acquitted of manipulating Invossa ingredient
A local court on Friday has turned down Kolon Life Science's appeal for suspending the execution of the government's order to stop making and selling Invosssa-K, an osteoarthritis gene therapy.
The Seoul Central District Court dismissed Kolon Life Science's application for suspending the execution of the administrative order issued by the head of the Ministry of Food and Drug Safety.
"The evidence submitted by the Ministry of Food and Drug Safety alone is lacking to admit that Kolon Life Sciences intentionally omitted and submitted a product license that would have adverse consequences," the court ruled. "However, as pharmaceuticals directly affect life or health of people, there is a serious flaw if there are any other facts not inside the product license."
Since the fact that the cells administered to the human body are kidney-derived cells has been confirmed, the ministry can revoke the product license directly, the court added.
The court stressed that there are also no violations in the ministry's procedure in revoking the product license of Invossa.
With the court's decision, the Ministry of Food and Drug Safety's decision to cancel the Invossa product approval will go into effect.
Besides, the court acquitted two Kolon Life Science executives of manipulating ingredients for osteoarthritis gene therapy Invossa-K and filing false documents to authorities in an earlier case on Friday.
The two officials -- an executive director of Kolon, surnamed Kim, and a director surnamed Cho, at Kolon Life Science – faced charges of submitting false data about Invossa’s ingredients to obtain permission from the Ministry of Food and Drug Safety.
The ruling is the first court decision that came after the prosecution investigated and prosecuted several Kolon Life Science officials in 2019 for mislabeling the cell ingredient of the second fluid of Invossa as cartilage-derived cells instead of kidney-derived ones when it submitted data to the drug regulator.
While the court admitted that the two executives had written in data inconsistent with some facts, it still found the two innocent citing that it suspected that the drug ministry's verification on Invossa during the approval process was insufficient.
The court also found Cho and Kim innocent of regarding charges of receiving a subsidy of 8.2 billion won ($7.4 million) after being selected as government business operators using the false data.
However, the court found Cho guilty of providing a bribe of about 2 million won to a Ministry of Food and Drug Safety official along with a request for providing favors during the development of Invossa. Cho received a fine of 5 million won.
Kolon TissueGene met its downfall in March of 2019, as the Ministry of Food and Drug Safety requested Kolon Life Science to discontinue the manufacturing and sales of Invossa-K. The request came after a short tandem repeat (STR) analysis of Kolon TissueGene had revealed the osteoarthritis treatment had a cell line different from the one permitted by the regulatory agency.
Invossa is comprised of 75 percent of human chondrocytes (HC) and 25 percent of transformed cells (TC). In 2004, the company thought TCs were derived from cartilage. However, it later found that TCs were HEK 293 cells derived from the kidneys.
Soon after the ministry's announcement, Kolon held a news conference and apologized for "mislabeling" one of its key compositions for Invossa-K. Simultaneously, the company stressed that the composition of Invossa-K remains unchanged and that the treatment's safety and efficacy have not been affected by the results.
Despite the company's claims, the Ministry of Food and Drug Safety eventually revoked the product license of Invossa in May of that year.
Since then, the company has been fighting numerous legal battles while trying to avoid delisting from the stock market.