A heated debate is continuing between Medytox and Daewoong Pharmaceuticals over a news report from Bloomberg over Daewoong’s Nabota, its botulinum toxin (BTX) strain.

According to Bloomberg, Allergan and its partner Medytox are seeking to block the U.S. imports of Nabota, also known as DWP-450 and Jeuveau, by submitting a complaint to the U.S. International Trade Commission claiming that Daewoong developed the treatment using stolen manufacturing secrets and turncoat former employees.

“Daewoong and Evolus, its U.S. partner, expect to begin North American sales of Nabota in February,” Allergan and Medytox said in the complaint. “Medytox contends a former employee handed over to Daewoong the results of its ‘meticulous, time-consuming, and expensive research’ into a new process to make a treatment based on the deadly botulinum toxin.”

Daewoong and Evolus can introduce DWP-450 into the U.S. market at a price that they have touted will be substantially lower than the cost of Botox, and to thereby undercut the market for Botox. That was because they were not required to make the massive research and development investments that Allergan and Medytox have incurred and continue to incur to develop their products, the two companies added.

Daewoong had boasted that Nabota would be 15 to 20 percent cheaper than Allergan’s Botox. Although Allergan is currently conducting phase 3 clinical trials into Medytox’s Innotox, a next-generation liquid-type BTX, it has yet to enter the U.S. market with the two companies not expecting to receive U.S. regulatory approval until 2022.

Daewoong criticized the complaint saying it was a strategy to restrain Nabota’s entrance to the U.S. market.

"The complaint is part of a strategy to keep us from entering the competition, which is a common threat in the U.S.,” the company said in a press release. “The complaint from Allergan and Medytox is groundless, and it will have no impact on commercializing Nabota in the U.S. market.”

The suit only demonstrates that Allergan and Medytox consider the superior quality and price competitiveness of Daewoong’s Nabota as a significant threat, it added.

Medytox refuted Daewoong’s claim saying that the U.S. International Trade Commission is an agency that investigates overseas products developed in an illegal way that can damage related industries in the country, and takes import restraint measures if necessary.

“We urge Daewoong Pharmaceutical to participate in a forum on how they acquired the BTX strains and clarified all doubts surrounding its product,” the company said.

The trade complaint is the latest for the two Korean companies.

In 2017, Medytox filed a suit against Daewoong and its U.S. partner Alphaeon for allegedly stealing the company’s botulinum toxin (BTX) strain to produce Nabota to a California court.

At the time, the court ordered the companies to settle the dispute in Korea first, while putting the case on hold saying that the matter will be discussed on April 13, 2018. Afterward, Medytox filed several complaints, including the prohibition of trade secret infringement, with a Seoul district court last year.

Despite the previous order, the court dismissed Daewoong on the grounds of forum non-conveniens last Saturday. The court, however, did not reject the Medytox’s case against Evolus and added that the matter stays pending the resolution of proceedings in Korea.

“The case is still proceeding in Korea, and if the ruling favors the company we will restart trials in the U.S.,” a Medytox spokesperson told Korea Biomedical Review.

The commission will consider the complaint and, if it decides to investigate the allegations, could make a final decision in about 15 to 18 months, Bloomberg reported.

corea022@docdocdoc.co.kr

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