Yesterday, AstraZeneca Plc (AZN) announced that Crestor, its cholesterol-lowering drug (statin) reduced the risk of heart attacks, strokes, artery-clearing procedures and death in elderly patients.
The results from the JUPITER study (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin), showed that Crestor 20mg reduced major cardiovascular events. The administration of the drug to a sub-set of 5,695 patients aged 70 years or above reduced the risk of cardiovascular events by 39% compared to placebo.
The study also revealed that Crestor reduced the risk of heart attack as well as stroke by 45% each in 17,802 patients (the total population of the study).
The results were presented at the European Society of Cardiology (ESC) meeting in Barcelona, Spain. Results from the randomized, double-blind, placebo-controlled study were initially presented in November 2008.
We feel that the analysis from the JUPITER study will expand Crestor usage to reduce the risk of cardiovascular events.
Crestor, initially developed by the Japanese pharmaceutical company Shionogi and in-licensed by AstraZeneca in April 1998, is approved in more than 95 countries.
The company’s cardiovascular franchise consists primarily of Crestor, Toprol XL and Atacand. Crestor continues to record solid growth despite the availability of several generic alternative statins. Crestor prescriptions grew by 25% in the recent quarter, four times the overall statin market.
Crestor sales in the most recent quarter exceeded $1 billion; it was the only branded statin to gain market share in the U.S. in 2008. Sales benefited from the promotion for the atherosclerosis (progressive buildup of plaque in the inner walls of the arteries) indication and the recent lack of efficacy perception for Merck & Co. Inc.’s (MRK) Vytorin. Management remains optimistic that Crestor’s superior efficacy relative to the generics will provide sufficient differentiation to enable further growth in U.S. sales.
AstraZeneca and Abbott Labs (ABT) are working on a co-formulated fixed-dose single pill that combines Crestor and Abbott’s next-generation triglycerides lowering pill TriLipix. The Crestor-TriLipix combination pill is known as Certriad.
Certriad was filed for FDA approval on June 4, 2009 for the treatment of mixed dyslipidemia, which is a combination of two or more lipid abnormalities including high LDL cholesterol (the bad cholesterol), high triglycerides and low HDL-cholesterol (the good cholesterol).
According to the American Heart Association, more than 100 million adults in the U.S. suffer from dyslipidemia. Of those, approximately 34 million people suffer from mixed dyslipidemia. If all goes well, Certriad could launch in the U.S. market during the second quarter of 2010.
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