Aegerion Pharmaceuticals said late yesterday it received a U.S. Department of Justice subpoena seeking documents related to its U.S. marketing and sale of Juxtapid (lomitapide), an anti- cholesterol drug.
“The company intends to cooperate fully with the government's investigation,” Aegerion said in a statement announcing the action by the Department of Justice, represented by the U.S. Attorney’s Office in Boston. The 73-word statement was tucked inside a press release announcing the company’s preliminary 2013 net product sales data.
“Aegerion is fully committed to complying with all applicable laws, rules, and regulations, and has compliance policies and programs in place consistent with this commitment,” the company added.
The FDA approved Juxtapid in December 2012 as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density-lipoprotein cholesterol (non-HDL) in patients with the rare genetic disease homozygous familial hypercholesterolemia (HoFH).
The Department of Justice is the second federal agency to question Aegerion’s promotion of Juxtapid in the past three months. Back in November, the FDA issued a warning letter to CEO Mark Beer following statements during interviews on CNBC’s “Fast Money” on June 5, 2013 and October 31, 2013.
In a warning letter, the FDA said that the statements “misleadingly suggest that Juxtapid is safe and effective for use in decreasing the occurrence of cardiovascular events including heart attacks and strokes, and increasing the lifespan of patients with HoFH, and thus will have an effect on cardiovascular morbidity and mortality as well as overall mortality."
“The statements provide evidence that Juxtapid is intended for new uses, for which it lacks approval and for which its labeling does not provide adequate directions for use, which renders Juxtapid misbranded within the meaning of the Federal Food Drug and Cosmetic Act (FD&C Act) and makes its distribution violative of the FD&C Act,” continued the warning letter, which was dated November 8 and signed by Robert Dean, M.B.A, R.A.C., division director of the FDA’s Office of Prescription Drug Promotion.
Yesterday, Aegerion said it finished 2013 with preliminary, unaudited 2013 net product sales of between $48 million and $49 million, exceeding the company's initial 2013 revenue guidance of between $15 million and $25 million—but in line with its most recent guidance of between $45 million and $50 million.
For this year, Aegerion projected net product sales of $190 million to $210 million.