Expanded Label for Crestor – Analyst Blog

AstraZeneca (AZN) recently received approval in 19 countries in the EU for expanded use of one of its key drugs, Crestor (rosuvastatin calcium). The drug can now be used for the prevention of major cardiovascular events in patients with increased risk of suffering from a first cardiovascular event.

 

Earlier, in February 2010, Crestor had received approval from the US Food and Drug Administration (FDA) for the treatment of patients with normal cholesterol levels but with increased risk of cardiovascular disease.

 

The EU approval was based on sub-group data presented from the JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) study conducted on 17,802 patients. A post hoc analysis of the data showed that Crestor lowered cardiovascular deaths, heart attacks and strokes in high risk patients.

 

The label expansion is likely to increase the targeted patient population which in turn should boost sales. Crestor is one of AstraZeneca’s key drugs, having logged sales of about $4.5 billion in 2009, up 29% year-over-year.

 

However, the future growth trajectory of Crestor may not be as smooth since Pfizer’s (PFE) Lipitor will lose patent exclusivity in 2011. The entry of generics will increase competition in the cholesterol lowering market, thereby leading to share loss.

 

AstraZeneca has a co-promotion agreement with Abbott Labs (ABT) for Crestor in the US market. AstraZeneca and Abbott have also been working on a co-formulated fixed-dose single pill, Certriad, which combines Crestor and Abbott’s next-generation triglycerides lowering pill, TriLipix.

 

Unfortunately, Certriad is yet to gain FDA approval. The FDA recently issued a complete response letter for the candidate and Abbott and AstraZeneca intend to meet with the FDA to determine the requirements for gaining approval.