Dual Crestor/ABT-335 pill to enter Ph III

Anglo-Swedish drug major AstraZeneca and US health care firm Abbott Laboratories say they plan to move their development of a fixed-dose combination of Crestor (rosuvastatin calcium) and the next generation fenofibrate ABT-335 into Phase III. The drug, which is designed to reduce "bad" low-density lipoprotein cholesterol, elevate "good" high-density lipoprotein cholesterol and cut triglyceride levels, is intended to provide a single-pill treatment option for lipid management.

Abbott and AstraZeneca have been collaborating on drug development since last summer (Marketletter July 17, 2006). They said, according to a report in the UK's Financial Times, that as a result of focusing on the ABT-335/Crestor combination they would not pursue development of a similar product comprising Abbott's Tricor and Crestor, which was also covered by last year's agreement.

Under the terms of the co-development deal, Abbott will be responsible for all clinical trials and conducting regulatory registration of the combination therapy, with submission to the US Food and Drug Administration planned for 2009. In addition, Abbott will file ABT-335 as a monotherapy by the end of the current year, and is evaluating the drug in combination with a range of other statins in a trial program expected to produce results in the first half of 2008.