Tennessee company in battle with European regulators over weight-loss drug
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Years before Ozempic became all the weight loss rage, two private equity firms bought a commercialized anti-obesity drug out of bankruptcy and formed a new company around it called Currax Pharmaceuticals.
Driving the news: Tennessee-based Currax now is locked in an unusual fight with European regulators, and alleging a possible conflict of interest that's tied to Ozempic.
What to know: Currax's drug is marketed as Contrave in the U.S. and Mysimba in Europe, receiving FDA and European Medicines Agency approvals in 2014.
- The U.S. is a much larger market for Currax than is Europe, although the company still claims more than 400,000 Mysimba prescriptions were written last year.
- The company argues that its orally-administered drug is focused on helping "emotional eaters," whereas GLP-1 medicines like Ozempic and Wegovy are about satiating "hungry gut."
Behind the scenes: Currax also has been in the process of launching a new study related to the drug's cardiovascular safety, as required by the regulatory approvals (a prior effort, by the previous owner, was not completed). The new study's protocol was developed in consultation with the FDA, but the European discussions were much more contentious.
- The EMA formed a scientific advisory group that found the FDA-authorized process would meet long-term safety needs, but that the EMA wouldn't adopt the recommendation.
- "It put me in a tough spot," says Currax CEO George Hampton, a veteran of drugmakers Abbott and Horizon. "I could agree with scientific leaders in the space and be adversarial with the bureaucrats, or agree with the bureaucrats and be disagreeable with the scientific advisory group."
- He adds that Currax tried to split the difference, requiring patients get a cardiology exam after one year of Mysimba use, but to no avail. Instead, the EMA issued an Article 20, a rare procedure for reviewing an already-approved product that could result in it being banned.
The intrigue: The EMA's lead rapporteur for Mysimba is a member of the Danish Medicines Agency who worked for Ozempic maker Novo Nordisk between 2015 and 2019.
- Moreover, she had "individual product responsibility" for the underlying peptide in Ozempic, according to a public declaration that the EMA recently removed from its website.
- "She worked on the molecule we compete with ... and comes from Denmark, where the entire economy is based on Novo Nordisk's success," says Hampton. "I was very surprised because they're usually very sensitive to this."
- He adds that Currax requested a different rapporteur, but was rebuffed. The EMA has not returned Axios' request for comment.
Cap table: Currax is primarily backed by Highbridge Capital Management and Whitebox Advisors.
The bottom line: Almost every big pharma company is now trying to get into the anti-obesity market, either competing directly on GLP-1's or in a side sector like is Currax.
- They're sure to watch how the EMA ultimately rules on Mysimba, as a possible signal for what awaits their own regulatory approval processes.
