It may not be a trend as yet, but for the second time recently, drugmakers have tried to put the kibosh on a competitor’s launch by alleging their product was made using stolen manufacturing secrets.
The most recent is a complaint filed Jan. 30 by Allergan and its Botox partner Medytox against Evolus and Daewoong, partners in Jeuveau, the biologic approved last week that will compete for some of Botox $3.6 billion yearly haul.
The complaint, filed with the United States International Trade Commission, alleged that a former Medytex employee stole trade secrets on the complex manufacturing process needed to turn botulism into a drug, as well as a sample of Medytex’ strain, Bloomberg reported.
The two companies have denied the allegations.
“Allergan and Medytox’s claims are completely without merit. This complaint and the associated timing reflect the level of concern surrounding Evolus’ entry and the competitive threat it presents to the Botox franchise,” Evolus said in an emailed statement. “This represents another legal maneuver in a long-litany of attempts by Allergan and Medytox to stifle competition and limit physician and consumer choice. Given this history, we have been prepared and will vigorously defend our intellectual property. This does not change our plans for a successful U.S. commercial launch of Jeuveau in the spring of 2019.”
The petition follows several other legal and regulatory efforts that Allergan and Medytex have attempted to try to roadblock competition from Evolus and others. (Allergan is the same company that in 2017 handed off six patents for Restasis to the Saint Regis Mohawk tribe in 2017 in a bid to shield the dry-eye treatment from generic competition—an effort that is now on appeal to the Supreme Court after being stymied by lower courts.)
The partners in December filed a citizen’s petition with the FDA that raised questions about the source of the strain used in the Evolus drug. It was reportedly turned down on Friday, the day the Evolus drug was approved. Medytox in 2017 also sued Daewoong in Korea, Bloomberg says, accusing it of getting trade secrets from a former Medytox employee.
Evolus actually had its manufacturing questioned by the FDA, but not for the same reasons. The agency last year issued a complete response letter to the Irvine, California-based biotech for its botulinum neurotoxin candidate, citing concerns about the so-called Chemistry, Manufacturing, and Controls (“CMC”) processes Evolus had established for manufacturing it.
According to notes to clients by analysts with Cantor Fitzgerald, the attempts “are just noise,” that will not affect the launch of Jeuveau, which they think will get faster uptake than some have suggested.
A similar scenario arose in the fall when prosecutors accused former Genentech employees of passing manufacturing and other trade secrets to JHL, a biosimilar maker started by former Genentech employees. In a followup lawsuit, Genentech accused the ex-employees of pilfering “analytical methods, formulation know-how, quality acceptance criteria, and manufacturing protocols” for cancer drugs Rituxan, Herceptin and Avastin, along with cystic fibrosis mediction Pulmozyme. The accused have denied the charges.
Genentech filed its lawsuit in federal court in California. The company is requesting damages, disgorgement of proceeds and an injunction barring the JHL from selling biosim versions to its drugs that benefited from stolen information.