Aegerion hits annual high on FDA panel vote
NEW YORK -- Shares of Aegerion Pharmaceuticals Inc. climbed Thursday after the company said a Food and Drug Administration panel recommended that its cholesterol disorder drug lomitapide be approved.
THE SPARK: The Cambridge, Mass., company said Wednesday that an FDA advisory panel voted to support approval of lomitapide. The drug is designed to treat homozygous familial hypercholesterolemia, an inherited disease that causes extremely high levels of bad cholesterol. Aegerion said the panelists concluded that the data Aegerion has presented shows that lomitapide is safe and effective when used with a low-fat diet and other therapies that reduce patients' lipid levels.
THE BIG PICTURE: The FDA is scheduled to make a decision on Aegerion's application by Dec. 29. The agency is not required to follow the advice of its panels, but it often does so. Aegerion has also asked European Union regulators to approve the drug.
Aegerion says patients with homozygous familial hypercholesterolemia have three to six times the normal amounts of "bad" cholesterol in their blood, and current treatments like blood filtration are generally not effective. The company said patients often die by the age of 30 because of heart attacks or strokes brought on by the disease.
The company is also studying lomitapide as a treatment for familial chylomicronemia, a rare genetic disorder that causes elevated triglyceride levels. Aegerion is a development-stage company with no approved products. The company took a loss of $25.6 million over the first six months of 2012 as its costs increased.
THE ANALYSIS: Analysts said it's not clear how many patients would take lomitapide. Lazard Capital Markets analyst William Tanner said Aegerion's estimate of 3,000 potential patients may be much too high, and Jefferies & Co. analyst Eun Yang said the patient population is probably between 3,000 and 300.
Tanner rates the shares "Neutral" while Yang holds a "Buy" rating.
SHARE ACTION: Aegerion shares rose $2.92, or 15.3 percent, to $22.07 in afternoon trading. Earlier the stock peaked at $22.63, its highest price since April 2011.