License of Kolon's Invossa revoked

Kang Seok-yeon, the chief of the biopharmaceutical policy division at the Ministry of Food and Drug Safety, speaks during a press conference at the agency's headquarters in Cheongju, North Chungcheong Province, Tuesday. / Yonhap

By Kang Seung-woo

The health authorities canceled the license for Kolon Life Sciences' osteoarthritis gene therapy drug Invossa, Tuesday, over the mislabeling of a key ingredient and the false reporting of this to them.

In addition, they have decided to pursue criminal charges against the pharmaceutical firm.

Invossa was the nation's first gene therapy drug for patients with the degenerative joint disease. The Ministry of Food and Drug Safety approved it use in Korea in July 2017 on the basis that it used cartilage-originated cells.

However, Kolon instead manufactured and sold the drug manufactured with a material different from that used at the time of approval. According to the ministry, the company used cells originating from the kidney.

“Kolon Life Science falsely reported ingredients, intentionally did not disclose additional data on the problem it discovered before submitting the drug for approval, and failed to provide a scientific reason for this,” the ministry said.

To see how and why the key material of the drug was changed, the ministry examined documents on the drug, while carrying out on-site inspections of the drug maker's production plants and research facilities in Korea and the United States.

The ministry said Kolon TissueGene, Kolon Life Science's U.S. affiliate, knew some of the Invossa ingredients were derived from kidney cells in March 2017, four months before approval was granted, and notified the parent firm of the fact via email one day after approval.

“Given that Kolon Life Science received the email at that time, it already knew the drug contained kidney cells. Under current regulations, the company should have told the truth even if it knew the fact one day after the ministry gave approval,” Kang Seok-yeon, chief of the ministry's Biopharmaceutical Policy Division, said during a press conference at its headquarters in Cheongju, North Chungcheong Province.

Kolon suspended the sales and distribution of Invossa at the end of March, following a ministry directive after it belatedly reported the ingredient change to the ministry.

Invossa was the 29th out of 30 novel therapies developed by a Korean company and approved by the local drug regulator, with 3,707 local patients being treated with it.

The drug has been sold in Hong Kong and Macau, with the manufacturer announcing in January that it reached an export deal to ship the medicine to Singapore and Indonesia. It also signed a deal to ship the product to China last year.

The ministry said there appear to be no safety problems with Invossa despite the changed ingredient. However, to check for possible side effects, it decided to conduct a tracking survey on the 3,707 patients for the next 15 years.

In the wake of the ministry's decision, angered patients who have taken the drug have taken legal action against Kolon ― although so far there have been no cases of side effects linked to it.

“Kolon needs to take responsibility for hiding its mistakes that directly have a bearing on the health of users and for trying to dodge responsibility,” Oh Kims Law and Company, a law firm representing 244 patients, said in a press release. It filed a complaint with the Seoul Central District Court later in the day.