Kolon soldiers on after setback with Invossa
In a press conference Thursday held at the Korea Press Center in central Seoul, the CEO of the biopharmaceutical affiliate of Kolon Group, Lee Woo-suk, publicly apologized for the furor over Invossa and announced that the company will work with its U.S. affiliate, Kolon TissueGene, to continue the U.S. Food and Drug Administration (FDA) approval process for Invossa.
“Moving forward, we will collaborate with Kolon TissueGene, original developer of Invossa, to resume U.S. Phase 3 clinical trials as soon as possible,” Lee said after bowing in apology.
“And we will also work with highly regarded academic experts, associations and institutions to again prove Invossa’s safety, efficacy and value as a new drug.”
Lee said Kolon TissueGene is expected to file a request with the FDA by July 15, but the date could be pushed back because of the vacation season.
Invossa, which was approved by Korean authorities in 2017, had its license revoked late last month after it was found that Kolon Life Science filed false documentation for its approval. The gene therapy drug for knee osteoarthritis was approved on the basis that it used cartilage 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 of Food and Drug Safety officially revoked the license for Invossa on Wednesday.
But Kolon Life Science said it has not given up on bringing Invossa back to the local market.
Lee said the company is preparing to file an administrative lawsuit to challenge the ruling. Even though a labeling mistake was made, he said, Invossa has already proven its effectiveness.
“We made a mistake, but we are certain of Invossa’s safety and efficacy,” Lee added. “Drugs are approved because they work, and the same case goes for our Invossa.”
Rebutting accusations that Invossa could cause tumors, Kolon Life Science again denied this risk and said it has used radiation on the drug to prevent its cells from multiplying out of control.
Prosecutors are currently investigating Kolon Life Science for possible fraud and called in its executives for questioning on Tuesday.
Also at the press conference, Kolon Life Science detailed its previously announced plan to track the health effects of the drug on 3,853 patients over 15 years.
The company said it is spending more than 50 billion won ($42.7 million) to administer 10 different tests to patients at 20 major hospitals across the country.
Kolon Life Science also plans to hold meetings with patients later this year. It added that 1,725 Invossa patients are enrolled in the plan and the company plans to enroll all patients by October 2019.
Hundreds of Invossa patients are taking the company to court.
Seoul-based OhKims Law & Company said Thursday that it is filling its second class-action lawsuit with 523 patients who were treated with Invossa. The first, with 244 patients, was filed in late May. The suits are asking for 10 million won for each patient.
BY KO JUN-TAE [firstname.lastname@example.org]