[Click e-Stock] "Kolon TissueGene: 'Pain Reduction' Is Top Priority for Osteoarthritis Drug"

As Kolon TissueGene accelerates its efforts to obtain U.S. approval for its osteoarthritis gene therapy 'TG-C' (formerly Invossa), Korea Investment & Securities has analyzed that 'pain reduction and functional improvement' are the key factors.

On October 23, Wi Haejoo, a researcher at Korea Investment & Securities, stated, "The U.S. Food and Drug Administration (FDA) requires data on 'pain reduction and functional improvement' as reported by patients as the basis for approving new osteoarthritis drugs." She explained, "The reason the FDA set this standard is that, in past clinical cases, cartilage regeneration or structural improvement was demonstrated, but there were cases where patients did not experience a reduction in perceived pain."

Researcher Wi added, "The primary endpoints of Kolon TissueGene's Phase 3 clinical trial for TG-C are also 'pain reduction and functional improvement.' If the company can provide evidence that patients who experience pain reduction also show cartilage regeneration in an inverse relationship, TG-C could be recognized as a DMOAD (disease-modifying osteoarthritis drug)."

TG-C is considered highly commercially viable. According to a 'willingness to pay for pain relief' study conducted in Canada, patients suffering from pain responded that they would be willing to pay $1,428 per month for pain relief, which amounts to $17,134 per year. TG-C is effective in reducing pain for at least two years with a single injection. Assuming a U.S. wholesale price of $25,000 per injection, the annual drug cost would be only about $12,500.

Researcher Wi commented, "Since the drug price will be positioned within the payment capacity of pain patients, there is a high likelihood that it will sell well." She projected, "If approximately 36,000 patients are prescribed TG-C in the third year after launch, sales will reach 1.2 trillion won, with a net profit of 291 billion won." The Phase 3 clinical trial for TG-C is expected to be completed in March next year, with results to be announced in July.

Researcher Wi maintained a 'Buy' investment rating and a target price of 100,000 won for Kolon TissueGene.