AstraZeneca Plc and Abbott Laboratories said U.S. regulators requested additional information on their Certriad heart treatment.
The drugmakers, in a statement today, didn't specify what information the Food and Drug Administration requested.
"We're not discussing any specific details," said Elizabeth Hoff, a spokeswoman for Libertyville Township-based Abbott, in a phone interview. "We're working to respond to the FDA feedback as quickly as we can."
Certriad aims to treat lipid disorders by combining two cholesterol-lowering medicines, Abbott's TriLipix and AstraZeneca's Crestor. The FDA said on March 15 that it's reviewing TriLipix after a study showed an older version of the drug, TriCor, failed to lower the risk of heart attack and stroke more than a generic cholesterol pill. Leerink Swann & Co. analysts estimate Certriad sales of almost $500 million by 2015.
Abbott said in October that it expects approval of Certriad in the first half. Both companies are betting that the drug will help offset sales lost to generic rivals. Crestor, London-based AstraZeneca's third-best seller, generated $4.5 billion in sales in 2009. Teva Pharmaceutical Industries Ltd. may introduce a copy of Abbott's TriCor in 2012.
The FDA request "will likely delay approval beyond Abbott's mid-2010 target," Rick Wise and Danielle Antalffy, analysts at Leerink Swann in New York, wrote in a note to clients today. "Though our mid-2011 launch timeline still seems achievable to us, any delay in Certriad approval is a setback."
AstraZeneca shares fell 38.5 pence, or 1.3 percent, to close at 2,941.5 pence in London trading. Abbott fell 16 cents, or 0.3 percent, to $52.97 at 12:23 p.m. in New York Stock Exchange composite trading.