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Abbott and AZ select next-generation fenofibrate/ statin combo

Abbott and AstraZeneca say they will progress the development of the next-generation fenofibrate ABT-335 and Crestor in a fixed-dose combination treatment into phase III clinical trials

US-based Abbott and UK-headquartered AstraZeneca (AZ) have revealed they will progress the development of the next-generation fenofibrate ABT-335 and Crestor (rosuvastatin) in a fixed-dose combination treatment into phase III clinical trials.

The single pill will target all three major blood lipids: low-density lipoproteins (LDL-C), High-density lipoproteins (HDL-C); and triglycerides.

ABT-335 is Abbott's next-generation fenofibrate and is in late-stage clinical trials. Both firms have decided to move forward with the combination therapy and say studies are proceeding to schedule.

AZís blockbuster statin Crestor and ABT-335 are both lipid-regulating treatments. ABT-335 has been shown to raise good cholesterol (HDL-C) and reduce triglycerides and LDL-C. Crestor has been shown to significantly reduce LDL-C, while raising HDL-C.

The new combination therapy is being investigated to address LDL-C, HDL-C and triglycerides simultaneously in a single pill, which could improve patient convenience and lipid outcomes.

Dr Eugene Sun, vice-president of global pharmaceutical clinical development at Abbott, said: "This decision highlights the opportunity for broader treatment in many higher at-risk populations. We're looking forward to exploring the potential of a combination treatment to address the needs of patients."

Dr James Blasetto, vice-president of Strategic Development at AZ, said: "We are committed to continually investigate new treatment options for patients at risk for cardiovascular disease. The combination of Crestor and ABT-335 may be an important option to help patients with mixed dyslipidaemia achieve their treatment goals."

Abbott will continue executing the clinical trial programme and be responsible for regulatory registration of the new combination therapy. AZ will hold the New Drug Application. Following successful completion of the clinical trial, a regulatory application for the new combination therapy is targeted for US submission in 2009.

4th September 2007

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