AstraZeneca And Abbott To Co-Develop And Co-Market A Single-Pill, Fixed-Dose Combination Of CRESTOR® And Next-Generation TriCor ® (ABT-335) In The United States

The fixed-dose combination therapy will be co-developed for the U.S. market based on Abbott’s proprietary, next-generation fenofibrate (ABT-335) currently in Phase III clinical trials and AstraZeneca’s marketed statin, CRESTOR® (rosuvastatin calcium).

In parallel, a combination product based on Abbott’s currently marketed fibrate TriCor® and AstraZeneca’s CRESTOR will also be evaluated. Final selection between the two programmes will be made based upon data generated from the initial studies.

ABT-335 is part of a class of medications called fibrates, which have been shown to raise HDL cholesterol and reduce triglycerides, a form of fat or lipid obtained through food sources. CRESTOR is part of a class of medications called statins, and has been shown to reduce LDL and raise HDL cholesterol. This combination could potentially address LDL and HDL cholesterol and triglycerides simultaneously in a single pill.

More than 100 million Americans suffer from lipid disorders. Of this number, 38 million American adults have LDL, HDL and triglycerides at levels which increase the risk for coronary artery disease and stroke. Patients with mixed dislipidaemia are expected to become a more prominent segment of the dyslipidaemic population due to the increased prevalence of metabolic syndrome and diabetes.

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 deliver the jointly designed clinical trial programme and will also be responsible for regulatory filing of the new combination therapy. AstraZeneca will hold the New Drug Application (NDA). Following successful completion of the clinical programme, a regulatory application is anticipated for submission to the FDA in 2009.

The effectiveness of the agreement is subject to the satisfactory completion of certain conditions, including obtaining customary Hart-Scott-Rodino antitrust clearance.

"We're excited by the opportunity this collaboration brings to serve an important area of patient need," said Tony Zook, Executive Vice President North America, AstraZeneca. “This represents an important further step in broadening the full, long-tem potential of CRESTOR for the treatment of lipid disorders.”

"Treatment guidelines emphasize the need to manage three important lipids by lowering bad cholesterol and triglycerides and increasing good cholesterol. Increasing evidence shows that addressing these three key lipid targets helps to protect patients from heart disease,” said Eugene Sun, M.D., Vice President, Global Pharmaceutical Clinical Development, Abbott. “This collaboration has the potential to provide physicians and patients with the first statin and fibrate combination in a single pill to simplify the comprehensive treatment of lipids."

About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.


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5 July, 2006

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