Jan 9 Aegerion Pharmaceuticals Inc said
on Thursday that it received a subpoena from the U.S. Department
of Justice, requesting documents related to the marketing and
sale of its cholesterol drug Juxtapid in the United States.
Aegerion shares fell more than 12 percent in extended
Juxtapid was approved by U.S. health regulators in December
2012 to treat patients with homozygous familial
hypercholesterolemia (HoFH), a rare genetic disease that impairs
the function of the receptor responsible for removing LDL-C or
"bad" cholesterol from the body.
The company said it intended to cooperate fully with the
Chief Executive Mark Beer had received a warning letter from
the U.S. Food and Drug Administration in November over
statements that the regulator said misleadingly suggested
Juxtapid was safe and effective in decreasing cardiovascular
events and could be used as a stand alone therapy.
The FDA asked that the company respond with a plan to show
it would not use promotional material containing the misleading
statements and a strategy to adopt corrective measures in the
marketing of the drug. ()
Juxtapid is the sole approved Aegerion product.
Aegerion on Thursday also reported preliminary net product
sales of between $48 and $49 million, in line with its most
recent guidance of between $45 and $50 million.
The Cambridge, Massachusetts-based company now expects net
product sales of $190 million to $210 million in 2014. Analysts
on average were expecting the company to post revenues of $204
million for the period, according to Thomson Reuters I/B/E/S.
Aegerion's shares were trading at $64.40 after the bell.
They closed at $73.75 on the Nasdaq on Thursday.