[Photo provided by Daewoong Pharmaceutical]
Daewoong Pharmaceuticals could be the next ill-fated Korean drug name to lose a license on a mainstay product on home turf after the U.S. International Trade Commission (ITC) Monday found it guilty of stealing a botulinum toxin strain from rival drugmaker Medytox in a preliminary ruling.
The ruling is a non-binding advisory opinion but if any potential evidence that can support the finding, Daewoo will likely see revocation in its botox product Nabota, market watchers say.
Under the Pharmaceutical Affairs Act, regulators can cancel approval or order business suspension against medicines registered by false or illegal means.
The ITC ruling comes as South Korea`s drug safety watchdog decided to revoke the permit of Medytox in the country for using an unapproved ingredient and fabricating related documents. Medytox has been in legal battle with Daewoong over the strain origin and any decision from their civil lawsuits will determine the fate of Daewoong’s Nabota, analysts say.
An official at the Ministry of Food and Drug Safety said a review process at the ministry will follow upon the release of the ITC’s ruling statement, but license revocation will also wait for domestic trial results.
If ITC upholds the verdict in final ruling that will lead to 10-year ban on sales of Daewoong’s botox products in the United States, its global partner Evolus in charge of the sales of Nabota could file for damages for the losses.
Nabota was approved in the U.S. in 2019 and is currently sold under the marketing name of Jeuveau.
By Kim Byung-ho and Minu Kim
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