Abbott, AstraZeneca seek cholesterol pill approval

June 4, 2009

(AP) -- Abbott Laboratories and AstraZeneca PLC on Thursday asked the Food and Drug Administration to approve a drug that combines their cholesterol pills TriLipix and Crestor.

Abbott's TriLipix is part of a class of drugs called fibrates that raise "good" HDL cholesterol while reducing triglycerides and "bad" LDL cholesterol. AstraZeneca's Crestor is a statin drug that lowers bad cholesterol while raising good cholesterol.

Studies conducted by the companies compared the combination pill versus separate treatment with statin and fibrate drugs.

The companies' application to the FDA seeks approval to treat dyslipidemia, a disorder characterized by elevated cholesterol and triglycerides, a type of fat found in the blood stream. More than 100 million adults in the U.S. have the disorder, according to the American Heart Association.

If approved, the drug would be marketed under the brand name Certriad.

Crestor was London-based AstraZeneca's third best-selling product last year with sales of $3.6 billion. Trilipix was launched last December. The drug had sales of $253 million in the first quarter, when combined with a related treatment called Tricor.

The two companies also said Thursday that AstraZeneca will begin co-promoting Trilipix to physicians in the U.S. Financial terms of the agreement were not disclosed.

U.S. shares of AstraZeneca slipped 7 cents to $40.77 in late morning trading while Abbott shares fell 57 cents to $44.55.

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