Invossa probe expands as gov't registers drug patientsAuthorities are widening their investigation into Kolon Life Science’s scandal-ridden gene therapy drug Invossa, banning the group’s former chairman from leaving the country and completing the registration of half the patients who have taken the drug, which was approved for commercialization based on false information.
The Ministry of Food and Drug Safety on Sunday said that as of June 12 it collected information on 1,516 patients from 311 medical institutions that were giving Kolon’s knee osteoarthritis drug Invossa.
The drug, which was approved by authorities in 2017, had its license revoked late last month, as the drug safety ministry found that the company had filed false documents for its approval. Invossa was approved on the basis that it used cartilage-originated basis cells, when in fact it used kidney cells.
The drug was taken off the market in April after the company revealed the presence of the cells.
The ministry is currently tracking down the patients who took the drug to test for potential side effects over a 15-year period. It estimates that over 3,000 patients in Korea were given Invossa. The ministry targets to complete registration of all patients by October this year.
Meanwhile, prosecutors have widened their probe into Kolon Life Science after the drug safety ministry reported them for investigation last month.
The prosecution recently placed a travel ban on Kolon Group’s former chairman Lee Woong-yeul.
Lee, who resigned from his post late last year, was reported to prosecutors for investigation by shareholders of its U.S.-based affiliate Kolon TissueGene. They filed a class action lawsuit on May 21.
Lee has significant influence in Kolon due to his sizeable stake.
The former group chairman is the second-largest shareholder of Kolon Life Science with a 14.4 percent stake. The former chairman was not included in the list of executives that the drug safety ministry reported for investigation late last month.
The wider investigation has focused on whether executives at Kolon Life Science and its U.S.-based affiliate Kolon TissueGene were aware that kidney cells were present in Invossa and intentionally hid the problem.
According to the drug safety ministry, an email between the two companies indicates they were aware of the problem as early as 2017. Company executives claim that they had no idea the kidney cells were present in the drug.
Prosecutors already raided the headquarters of Kolon Life Science, Kolon TissueGene’s Seoul office, and the drug safety ministry.
The government has also been on the spotlight over the scandal, as a civic group reported the drug safety ministry to prosecutors last month for gross negligence in authorizing Invossa.
The ministry issued an apology earlier this month and promised to prevent similar cases in the future.
Kolon Life Science will present its case against Invossa’s license cancelation on Tuesday in a ministry hearing. The ministry will make a final decision on the revocation of the license based on the hearing.
The Korea Exchange is also reviewing whether to delist Kolon TissueGene, as its parent company’s executives face possible criminal charges.
Kolon TissueGene’s shares have been suspended since May 28.
BY CHAE YUN-HWAN [firstname.lastname@example.org]