Government revokes license for gene therapy drug Invossa

The Ministry of Food and Drug Safety has canceled the license for gene therapy drug Invossa on Tuesday because its manufacturer intentionally hid a mislabeling mistake and lied to the ministry.

The ministry said Kolon Life Science filed false documents when receiving approval for the drug and failed to provide scientific evidence to explain how its key ingredient was changed in the manufacturing process.

It is also going to file a criminal complaint against Kolon Life Science in regard to the scandal.

Invossa was approved for commercialization in Korea in July 2017, becoming the first drug to use gene therapy to treat osteoarthritis. The drug was taken off the market on April 1 this year after Kolon Life Science found that a kidney cell line, which was not previously disclosed and approved by the Ministry of Food and Drug Safety, was included.

Invossa was granted approval for commercialization on the basis that it used cartilage-originated basis cells.

The ministry again emphasized that public safety is not an issue as no threatening side effects were reported during the 11 years Kolon Life Science conducted clinical trials and was sold. The injectable drug was administered to 3,403 patients and distributed to 443 hospitals and clinics in Korea since officially being released.

The Food and Drug Ministry has been conducting an investigation on its own to verify details and visited Kolon TissueGene based in Rockville, Maryland, last week.

As the license has been pulled, Kolon Life Science will have to start the clinical trial process all over again if it wants to seek approval for Invossa in the future.

Kolon Life Science initially argued that “technical limitations” in the early 2000s prevented researchers from properly identifying the basis cell for Invossa, saying it was only after using more advanced analysis methods this year that the company found the basis cell to be kidney-originated instead of cartilage-originated.

However, Mitsubishi Tanabe Pharma, a Japanese pharmaceutical company, disputed the timeline earlier this month and argued that Kolon TissueGene, a subsidiary of Kolon Life Science, knew that an errant cell line was utilized in making Invossa two years earlier that it originally said.

The Japanese company said that Kolon TissueGene received a test result on Invossa that indicated the existence of a kidney cell line from Lonza, a Swiss manufacturing firm, in March 2017.

Kolon Life Science later acknowledged that its affiliate did receive the report in 2017, but insisted that it did not notice that kidney cells were discovered. It said Kolon TissueGene only mentioned the fact that no non-human cells were found in the results.

“The employee must have focused on the fact that there was no problem in producing the drug, not on the fact that an errant cell line was discovered,” a Kolon Life Science executive said on May 6.

Lonza conducted Short Tandem Repeat (STR) analysis to verify that only human cells were used, the company added.

Yet the news of an earlier test has been raising the possibility that the company has been lying to the government, patients and investors all along, with many wondering why Kolon Life Science did not conduct an STR analysis on Invossa on its own.

Kolon Life Science is now facing lawsuits from patients around the world over the mislabeling scandal. OhKims Law & Company announced Monday it is going to file a class-action lawsuit on Tuesday afternoon with 244 patients who were injected with Invossa.

According to the firm, Kolon Life violated the Pharmaceutical Affairs Act as it manufactured and sold pharmaceuticals that do not match the licensed version of the drug. The lawsuit will seek monetary compensation for the cost of the gene therapy drug and psychological harm.

In regards to the ministry’s announcement, the Korea Exchange suspended the shares of Kolon Life Science and Kolon TissueGene from being traded Tuesday.

BY KO JUN-TAE [ko.juntae@joongang.co.kr]