Korea's Ministry of Food and Drug Safety approved the sale of gene therapy product “Invossa” to treat degenerative knee arthritis of Kolon Life Science’s development on July 12. This marks the first approval of the sale of a gene therapy drug in Korea and the 29th approval of the sale of a new Korean drug. This means also that the dream of new medicine development, which Kolon Group chairman Lee Woong-yeul has pushed ahead with over the past 19 years, has finally come to the realization.
"We determined the final approval by reviewing Invossa’s degree of pain relief and improvement in the cartilage structure, and negative side effects, and consulting the Central Pharmacist Deliberation Committee," the ministry said. Kolon Life Science is expected to start selling the product in Korea as early as September.
The permit of the sale made Invossa the 10th gene therapy drug in the world. Invossa is a gene therapy product based on cartilage cells derived from allograft cartilage to which protein 'TGF-β1 gene' with inflammation suppressing effect was inserted.
The Korean market of arthritis drugs was estimated at one trillion won and the world market at 39.2 billion dollars as of last year. Experts expect the arthritis drug market to swell explosively in the future as people’s life expectancy increases and the obese population grows.
According to the Ministry of Food and Drug Safety, only four gene therapy products have been licensed by major advanced pharmaceutical countries such as the US and Europe. Among them, Invossa is the first gene therapy product for knee arthritis. Kolon Life Science said that if regenerating genes are injected into cartilage cells, pain relief will continue for one to up to two years.
It is not clearly confirmed how much cartilage Invossa can regenerate. "The current arthritis treatment will be effective only if it is given after surgery or once every two months whereas Invossa will continue to relieve pain for one to two years with one injection without surgery," Kolon said. "As Invossa is a human body-friendly drug, it has fewer side effects compared to conventional drugs."
However, the ministry did not acknowledge Invossa’s effects as a disease-modifying osteoarthritis drug (DMOAD) as hoped by Kolon Life Science. "Invossa’s effect of improving structures such as cartilage regeneration did not show any difference compared to the control group," the ministry says. “The range of prescriptions was also limited to moderate patients who failed medication and physical therapy. The degrees of knee osteoarthritis are doubtful, light, moderate, and severe. Invossa can be prescribed to third-stage 'moderate' patients only.” "Cartilage regeneration effects can be determined via long-term observation. We will prove them through large-scale clinical trials to be conducted in the United States."
Kolon will launch Invossa’s overseas expansion on a full-scale. In November last year, Kolon Life Sciences signed a contract with Mitsubishi Tanabe Pharma to export 500 billion won worth of Invossa technology. The volume was the highest as one single technology export to a country in the domestic pharmaceutical and bio industries. Starting next year, Tissue Gene, a US corporation of Kolon, will start Phase 3 of its clinical trial in earnest. Considering the clinical period and the US Food and Drug Administration (FDA)’s approval period, it is expected that Invossa will begin to hit the market in the US by the end of 2022. Chairman Lee is planning to spend roughly 190 billion won in the expansion of Chungju Plant and for clinical trials in preparation for overseas exports.