- Aegerion Pharmaceuticals will plead guilty to two misdemeanor violations of the Food, Drug and Cosmetic Act for misbranding its cholesterol drug Juxtapid, and will pay $40 million in penalties to the Department of Justice and the Securities and Exchange Commission, the company said in a statement.
- Under the agreement in principle with the DOJ, Aegerion admits to illegally marketing the drug with inadequate directions for use and failing to comply with requirements for a risk mitigation program.
- Additionally, the SEC accepted a settlement offer from the company under a neither-admit-nor-deny basis for improper statements made by Aegerion in 2013 over the conversion rate of patients on Juxtapid.
Juxtapid was approved by the Food and Drug Administration in 2012 for treatment of homozygous familial hypercholesterolemia, a rare genetic disease which leads to high levels of LDL-C, or "bad" cholesterol.
In 2015, sales of the drug made up nearly 90% of Aegerion's revenue, or $213 million out of $240 million in total sales. There were only 615 patients actively taking Juxtapid globally in December 2015, a number that has declined steadily. The company had expected sales to drop by $50 million to $80 million in 2016, and recently cut its workforce by 25% to lower expenses in line with that revenue figure.
The settlement with the DOJ and SEC only adds to the company's troubles with Juxtapid. The markets reacted sharply; Aegerion stock dropped nearly 17% in Thursday trading.
In a statement on the settlement, the company sought to turn a page. "We look forward to putting these matters behind us and to continuing our focused efforts on developing and commercializing innovative therapies for patients with debilitating rare diseases," said CEO Mary Szela.
Aegerion has also agreed to enter into a five-year deferred prosecution agreement over violations of the Health Insurance Portability and Accountability Act, as well as a civil agreement with the DOJ over alleged breaches of the False Claims Act.