Kolon Confident of Gaining US FDA Approval for Invossa

Lee Beom-seok, president of Kolon TissueGene Inc., is confident that the US Food and Drug Administration will give the green light to phase III clinical trials on Invossa, the world’s first knee osteoarthritis genetic therapy.

“We have already secured 60 sites for the clinical trials and will add another 10 later. We expect the trials to begin in the second half of this year as planned,” Lee said. He met reporters on the sidelines of the Bio USA exhibition held in Boston on June 5 (local time).

Kolon TissueGene plans to complete clinical trials in the US by 2021 and launch the new drug in 2023. Its goal is to make Invossa the world’s first “disease modifying osteoarthritis drug (DMOAD).” In Korea, the drug failed to win the DMOAD approval due to the small number of sample patients and the short testing period.

However, the company aspires to enter the global market by obtaining a DMOAD approval in the US market. In order to gain the approval, the drug must not only alleviate simple pain or improve body function, but structurally control or cure osteoarthritis.

In Korea, the company conducted phase III clinical trials on 156 patients in 12 hospitals. But in the US, the number of patients will be increased to 1,020 in 70 hospitals.

The company will also screen and track patients for 24 months in the US clinical trials, double the period set for the trials in Korea. The extended tracking period will make it easier to prove Invossa’s structural improvement effects.

Kolon TissueGene is investing a whopping 130 billion won (US$11.7 million) in clinical trials in the US.

Lee said the US approval of Invossa would pave the way for its entry into the European market. “We’ve heard from the European Medicines Agency that they would accept the testing results from the US,” he said, adding, “The product launch in Europe will occur about one year after the US.”

Kolon TissueGene plans to forge partnership with an overseas company by the end of this year to facilitate its push for Invossa in the global market.

Lee highly praised Invossa’s performance in Korea. The number of procedures of Invossa has surpassed 1,000. Since the release in November, Invossa has marked more than 100 procedures per month. Invossa-available hospitals are steadily increasing as well.

“Normally, it takes about four years to see a sales increase in pharmaceuticals. Invossa hit high figures in a short period of time and there has been no customer complaints,” Lee said.

Once sales of Invossa begin in the US in 2023, Lee said annual sales would reach 5.4 trillion won (US$4.8 billion).