Allergan has been more than willing to do whatever necessary to protect its secret process for making blockbuster Botox. After filing a trade theft investigation against a competitor, the drugmaker hoped a judge would keep its secrets hush-hush a little longer.
It was wrong.
A U.S. International Trade Commission judge has ordered Allergan to turn over details of its Botox manufacturing to Evolus and South Korea-based Daewoong, the makers of rival Jeuveau, as part of an investigation the Irish drugmaker requested in February.
Allergan and Medytox in January accused a former employee of Medytox, which co-manufactures Botox, of stealing trade secrets on the complex manufacturing process needed to turn botulinum toxin into a drug, as well as a sample of Medytox’s strain. That complaint followed a lawsuit Medytox filed in 2017 against Daewoong on the same claims.
In a ruling July 2, Judge David Shaw rejected Allergan’s theft claims, siding with Daewoong’s argument that the information on Botox’s manufacturing available in the public domain could shield Daewoong from wrongdoing, according to Bloomberg.
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However, ITC staff, which originally determined that the trade secrets should be disclosed, changed its mind. That shift in thinking could provide Allergan an opportunity to appeal Shaw’s ruling in front of the full commission, Bloomberg reported.
The ITC investigation is only the latest in Allergan’s attempts to stave off Jeuveau. In December, Allergan and Medytox filed an ultimately failed citizen’s petition with the FDA, raising questions about the source of the botulinum strain used in the Evolus drug.
It’s also not the only time Allergan has played hardball with competitors to hamstring rival drugs. In 2017, Allergan handed off six patents for Restasis to the Saint Regis Mohawk tribe in a bid to shield the dry-eye treatment from generic competition. A U.S. judge rejected that patent defense, and the U.S. Supreme Court eventually refused to hear Allergan's appeal.
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Botox’s blockbuster sales aren't just important to Allergan now, either. The strength of the drug’s growth will play a big part in determining the success of its $63 billion merger with AbbVie, and analysts have kept a watchful eye on its trajectory.
Botox hit $545.8 million in worldwide sales in the second quarter, including a 6.7% increase in U.S. sales as a cosmetic to $252.4 million. Other indications raked in $175.8 million in the U.S.
That mid-single-digit growth is nothing to sniff at, but it was a significant drop from the equivalent 16.7% growth the drug posted in the first quarter. Allergan didn’t offer an explanation for that drop, but it could be tied to the ongoing launch of Jeuveau, which pulled in a small $12.6 million in U.S. sales in the second quarter.
Jeuveau, which launched at a premium over Botox, is considered the strongest challenger to the blockbuster with positive doctor survey responses and impressive head-to-head data in treating moderate-to-severe glabellar lines.