Daewoong Pharmaceutical will submit a sample of its botulinum toxin (BTX) to experts outlined by Medytox by Wednesday as part of a US International Trade Commission investigation.

The firms announced Monday that they anticipate this latest development would settle the dispute that has dragged on since 2016 regarding the origin of Daewoong’s BTX. Medytox claims its former researcher illicitly transferred a BTX sample to Daewoong in the process of changing affiliations.

Daewoong gained the US Food and Drug Administration’s approval of its BTX product Nabota under the name Jeuveau in February and is gearing up to begin sales this month. The company said it anticipates to completely put an end to Medytox’s allegations. 




“We will sincerely comply with the ITC investigation to prove that Medytox’s accusations are baseless,” Daewoong said.

Daewoong argues its BTX is not the type A Hall hyper toxin as argued by Medytox, but a similar yet different strain of the toxin discovered in the soil in Yongin, Gyeonggi Province. Daewoong’s Nabota is special in that it can be applied to patients in the exact same amount and method as Allergan’s Botox, but at a significantly cheaper price.

Medytox, together with partner firm Allergan, filed a suit against Daewoong and partner Evolus at the USITC. The official USITC investigations started on March 1.

An identical suit is underway in South Korea, with spore appraisals of both Daewoong and Medytox’s BTX scheduled at an unspecified date.

Jeuveau will launch in the US this month. It is expecting results from the European Medicines Agency by the end of June, and is scheduled to begin phase 3 clinical trials in China in the second half of this year.

Daewoong Holdings meanwhile announced Monday that it would buy 26,455 shares of Daewoong Pharmaceutical at 5 billion won ($4.2 million) on Tuesday.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)