FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs / Inspections and Audits / Commercial Operations

Aegerion Warns Juxtapid Flap Could Impinge Image, Solvency

March 11, 2014
A A

Aegerion Pharmaceuticals says a Department of Justice probe and a resulting class action lawsuit related to the marketing of its sole product Juxtapid is draining company funds just as the company is moving to kick-start pediatric clinical trials in support of expanding the drug’s use.

Aegerion said in a recent SEC filing that it’s not backing down from its legal troubles, but its defense has been “costly and time-consuming” and the company worries that the Juxtapid (lomitapide) brand has been irreversibly tarnished.

“This investigation could adversely impact our reputation and the willingness of physicians to prescribe lomitapide for their [homozygous familial hypercholesterolemia (HoFH)] patients,” the filing states.

Aegerion got into hot water with the FDA last year shortly after Juxtapid’s approval. In an appearance on live television, CEO Marc Beer touted the drug’s ability to treat cardiovascular morbidity and mortality, indications the drug is not approved for. That drew a warning from the agency for failing to mention drug risks and promoting an off-label use.

While the company was already working on a response, DOJ in January issued Aegerion a subpoena asking for all promotional materials related to the drug. A spokesperson said at the time that Aegerion didn’t believe the demand was related to Beer’s comments.

The cascade of bad news prompted a nosedive in Aegerion stock, and soon after, a class action lawsuit filed by shareholders alleging that Aegerion executives violated federal securities laws.

Despite its troubles, the drugmaker says it still plans to conduct clinical trials to support a marketing authorization application for lomitapide in HoFH in Japan and in support of the company’s planned clinical study of lomitapide in pediatric and adolescent HoFH patients.

One year after launching Juxtapid, the drug has generated $48.5 million, and the company estimates it will generate between $190 and $210 million this year. — Ferdous Al-Faruque

Subscribe to Drug Industry Daily for complete coverage of the pharmaceutical industry. Click here for more information.