Prospects for Entering China Dimmed
Meditox is facing the biggest crisis since its foundation. The Korean Ministry of Food and Drug Safety has recently banned the company from selling its wrinkle improvement agent Meditoxin (main ingredient: botulinum toxin).
Industry watchers say that the ministry’s action against Meditox has dimmed the prospect of the company entering the Chinese market. Meditox has completed Phase 3 clinical trial on Mditoxin in China and is waiting for sales permission. Yet the Korean government’s cancellation of the license given to the product is highly likely to lead to a similar decision by the Chinese government.
Industry insiders also say that the Korean government’s action would also adversely affect Meditox’s ongoing litigation in the United States against Daewoong Pharmaceutical. Meditox licensed out its technology for Innotox, a liquid injectable form of botulinum Toxin type A, to Allegan in 2013. Yet prosecutors have found that test reports for Innotox had been fabricated. Allergan, which accounts for 70 percent of the world's botulinum toxin formulation market with Botox, is conducting Phase 3 clinical trial on Innotox in the United States, with the goal of ending it in January of 2021. Together with Meditox, it has filed a complaint against Daewoong Pharmaceutical for stealing botulinum toxin strains from Meditox.
In the meantime, industry insiders said that the ministry’s action was stronger than expected in light of the fact that the ministry acknowledges the safety of Meditoxin.