AstraZeneca and Abbott team up on lipid control pill

Under the agreement, the companies will initiate two parallel programs. One of these will evaluate a combination of Crestor with Abbott’s already marketed fibrate TriCor, while the other will evaluate a combination of Crestor with ABT-335, Abbott’s proprietary next-generation fenofibrate currently in phase III clinical trials.

One of the two programs will be selected for final development and commercialization based upon data generated from the initial studies.

Such a combination of a statin and a fibrate would potentially address LDL-C, HDL-C and triglycerides simultaneously in a single pill, and is thus expected to lead to improved compliance and outcomes.

According to the American Heart Association (AHA), more than 38 million Americans have complex lipid disease and may benefit from this new combination. The cholesterol market is currently valued at $17 billion of which combination therapy makes up 15% and represents the fastest-growing segment of the overall cholesterol management market.

“This collaboration has the potential to provide physicians and patients with the first statin and fibrate combination in a single pill to comprehensively manage lipids,” said Dr Eugene Sun, vice president of global pharmaceutical clinical development at Abbott.

The overall intention of the agreement is for the two companies broadly to share development costs and profits over the duration of the collaboration. Abbott will execute the clinical trial program and be responsible for regulatory registration of the new combination therapy. AstraZeneca will hold the new drug application (NDA).

Following successful completion of the clinical program, a regulatory application for the new combination therapy is targeted for submission in 2009.