Botox battle: Allergan attempts to block sale of injectables competitor in US market with support of ITC

By Becky Bargh | Published: 9-Jul-2020

The US’ International Trade Commission agreed that Daewoong’s rival product, Jeuveau, was unfairly sold in the US market, however, the full details of the decision have not yet been disclosed

The US’ International Trade Commission (ITC) has sided with pharmaceutical goliath Allergan in an attempt to block the sale of a Botox competitor in the US market.

In the case filed by Allergan in January 2019, the company accused Daewoong Pharmaceuticals, a South Korean bioengineering firm, of creating a product, called Jeuveau, that will “directly compete with Botox and undercut Botox significantly”.

Allergan also alleged that in order for Daewoong to create Jeuveau, Daewoong “misappropriated trade secrets” from its South Korean partner Medytox, specifically processes on how to create its botulinum toxin substance Meditoxin.

The documents name the former Allergan employee the company believes ‘stole’ the documents, who went on to work for Daewoong.

Byung Kook (BK) Lee is said to have printed 17 copies of Medytox's Batch Record and two copies of its Characterization Report that contain “nearly all the information needed” to develop a botulinum toxin.

The Characterization Report is also said to give a step-by-step manufacturing process for Medytox’s Meditoxin Drug Substance, the product Daewoong is said to have copied.

However, in its response, Daewoong argued trade secrets could not have been taken from Medytox’s product, Meditoxin, due to the fact that its CEO was indicted for “falsifying records and using unapproved drug substances”.

As a result, Meditoxin was pulled from the Korean market earlier this year.

The preliminary statement of its submission reads: “Based on this gross misconduct, the Korean Ministry of Food and Drug Safety (MFDS) provisionally suspended all manufacture and use of Meditoxin.”

In a press statement revealed to Cosmetics Business Medytox apologised to customers and investors for concerns regarding actions taken against the firm.

“Medytox again offers a sincere apology to its shareholders and customers.

“Taking this opportunity, Medytox will do our best to prevent this from occurring again in the future by preparing internal verification processes and strengthening a continuous monitoring system,” the firm said.

Despite this retaliation from Daewoong, the Washington DC judge sided with Allergan that the firm violated section 337 of the Tariff Act 1930.

Section 337 is defined as “unfair methods of competition and unfair acts in the importation of articles into the United State”, according to the World Trade Organization.

The full details of the judge’s decision have not yet been released.

While the decision will not have any immediate effect on the trade or sale of Jeuveau in the US, Daewoong will now have to petition the ITC to review the initial decision made by the judge.

“We strongly disagree with the initial determination and we look forward to the full Commissions’ final determination targeted for November 6 2020,” said David Moatazedi, President and CEO of Evolus, Jeuveau’s US distributor.

“In addition, we intend to petition the Commission to review the initial determination.”

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