Kolon Life tests suggest Invossa suspension end

The manufacturing of Invossa has involved the use of the same errant cell line since the very beginning of development, Kolon Life Science announced Monday after conducting tests on the knee arthritis drug.

The company claims the result demonstrates that all trials and tests and data generated over the past 15 years were based on the same material and that there should be no concern about new cell lines being introduced along the way. If this conclusion is confirmed and accepted, the suspension on the sale and distribution of Invossa might be lifted.

Invossa, No. 29 on the chronological list of 30 original Korean-made drugs, is the first drug in Korea to use gene therapy to treat osteoarthritis. The Ministry of Food and Drug Safety approved the drug to be commercialized in July 2017.

Kolon Life Science had positive expectations for the drug as the U.S. Food and Drug Administration (FDA) approved its affiliate, Kolon TissueGene, to conduct Phase 3 clinical trials at 60 U.S. hospitals last year.

But the company discovered earlier this month that a kidney cell line not mentioned in the data it submitted to the Ministry of Food and Drug Safety was included during production of the gene delivery medium.

Kolon Life Science CEO Lee Woo-suk said in an emergency press conference on April 1 that “technical limitations” in the early 2000s prevented researchers from properly identifying the basis cell for Invossa. It was only after further analysis using more advanced methods this year that the company found the basis cell to be kidney-originated instead of cartilage-originated, Lee said.

The company suspected that the cells used in Korea could be the same as the cells used in the United States and decided to halt the distribution and sale of the drug until it receives further updates from the ministry. Since then, the ministry has banned doctors from prescribing Invossa to patients and requested them to prescribe painkillers and steroids.

Two weeks after the suspension, the company confirmed through its own inspection that all Invossa products contained the same kidney-originated cells and delivered the results to the ministry.

“We confirmed that transformed cells had been 293 [kidney-originated] cells from the preclinical stage to date,” Kolon said in a statement Monday.

“We will be working transparently and faithfully to cooperate and make all efforts to relieve the anxiety of patients as soon as possible.”

The ministry confirmed Kolon’s test results in a statement Monday and demanded the company to provide documents within a month to prove its claim that kidney cell line was included in the very first stage of clinical trials held in the country.

“Our ban on sales and distribution of Invossa is still in effect,” a ministry spokesperson said.

The ministry will also verify whether Invossa being tested in the United States contained the kidney cell line from the initial development stage. Kolon suspended patient recruitment for its Phase 3 clinical trials in the country upon discovering the labeling mistake.

Although public safety is not an imminent issue, the ministry is also going to track health changes in Invossa-injected patients.

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