By Nam Hyun-woo
Medytox has denied reports that the Chinese government halted a review process for its botulinum toxin (BTX) product, Medytoxin, saying that it will hold those spreading false rumors legally accountable.
The company said Wednesday it has never been told by the China Food and Drug Administration (CFDA) that the agency stopped an approval screening for Medytoxin.
“The CFDA has been conducting the screening as scheduled without any problem. The process is in its final stage,” a Medytox official said. “The recent false media reports were based on malicious rumors provided by former company employees working close with Daewoong Pharmaceutical. The ongoing legal dispute with Daewoong will come to an end when it discloses data on its botulinum toxin (BTX) strain used for Nabota and manufacturing processes.”
Daewoong and Medytox have been in a legal battle in and outside Korea over the controversial BTX strain. Daewoong claims it found the strain in a barn in Yongin, Gyeonggi Province, while Medytox argues it was stolen from them.
In May, the U.S. International Trade Commission (USITC) ordered Daewoong to submit the BTX strain data for Nabota to a group of experts designated by its rival Medytox. Before the order, Daewoong had refused to submit data to the USITC, citing confidentiality.
Daewoong's Nabota, titled Jeuveau in the U.S., won a U.S. Food and Drug Administration approval for the treatment of “frown lines” in February and recently won a recommendation for European approval from the Committee for Medicinal Products for Human Use, a committee under the European Medicines Agency.?
In 2016, Medytox filed a complaint with Korean police that Daewoong stole its BTX strain and filed a suit with the Orange County Court in southern California in 2017. But the U.S. court dismissed the case and Medytox filed a separate suit with a Korean court.?