The U.S. International Trade Commission recently announced it will uphold the ban on Jeuveau, changing its original sentence from 10 years to 21 months.
The U.S. International Trade Commission upheld a judge’s ruling finding that Evolus Inc. and partner Daewoong Pharmaceutical Co. manufactured injectable neurotoxin Jeuveau with a process stolen from AbbVie Inc., the biopharmaceutical company that owns Botox, according to a recent Bloomberg business article.
Allergan, an AbbVie company, and Medytox, Inc., claim a former employee handed over the results of its research into a new neurotoxin to the competing company.
The case was initially filed at the Washington agency in February 2019, days before Evolus was to receive U.S. regulatory approval to sell Jeuveau.
Generating $35.2 million in the nine months it was available, which ended Sept. 30, a Daewoong spokesperson told Bloomberg that the import ban “would be a significant blow to an American company, will cost U.S. jobs amid the recession and will hurt consumer choice, innovation, and healthy competition in this marketplace.”
Manufactured using a secret process, the ruling was updated with the information that the bacterial strain involved isn’t covered by trade secrets. This reduces the initial 10-year ban on the import of Jeuveau to 21 months.
After the commission judgment was announced, Evolus shares plummeted by as much as 23% but rose as much as 30% in early trading the next day.
The ban will take effect after a 60-day presidential review period in which either President Trump, or after Jan. 20, President-elect Joe Biden could veto on public policy grounds. Notably, this action is rarely taken.
The commission also issued a cease-and-desist order for Evolus, which limits the company’s product availability. While they are not able to sell product they’ve already imported to the U.S. market, the order does not affect product already sold to its customers.
The company can continue selling Jeuveau during the presidential review period as long as it also posts a bond of $441 for each 100-unit vial, which they plan to do.
“There’s no immediate impact to the availability of Jeuveau in the United States,” says Crystal Muilenburg, a spokeswoman for Evolus, in the article. “We will now focus on overturning the decision by mobilizing interested parties close to this matter through the presidential review process. We remain committed to finding a resolution to this legal matter, including reasonable settlement terms with Allergan’s new owner, AbbVie, and Medytox.”