Pfizer Updates Preliminary Results Of Torcetrapib/Atorvastatin Clinical Trials As Abstract For Phase 3 Study Is Released

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials
Article Date: 01 Nov 2006 - 0:00 PDT

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Pfizer Inc today provided an update on the preliminary results of its torcetrapib/atorvastatin clinical trials in connection with the release of an American Heart Association abstract of a Phase 3 study in patients with heterozygous familial hypercholesterolemia (HeFH) that shows the drug significantly raising 'good' (HDL) cholesterol (56 percent) and additionally lowering 'bad' (LDL) cholesterol (27 percent) versus patients taking atorvastatin alone.

The HeFH study also showed patients in the torcetrapib/atorvastatin group experienced an average increase in systolic blood pressure of about two millimeters versus patients taking atorvastatin alone. The HeFH study, in patients with an increased risk of heart disease, will be presented at the American Heart Association Annual Scientific Sessions on November 15.

"We are pleased with the results of the HeFH study, and our overall lipid results from all the trials completed are very positive," said Dr. Joseph Feczko, Pfizer's chief medical officer. "They generally show torcetrapib/atorvastatin significantly increasing 'good' cholesterol by 55 to 60 percent and additionally lowering 'bad' cholesterol by 10 to 15 percent over atorvastatin alone (leading to a combined reduction in LDL of 50 to 60 percent), which supports our fundamental premise: this innovative medicine really can 'do both' and manage total cholesterol successfully.

"Our overall Phase 3 results to date, which are incomplete and must be rigorously analyzed when all the lipid and imaging trials are finished, also show an average increase in systolic blood pressure of approximately one millimeter of mercury above the two-to-three millimeter range that was observed in Phase 2 studies, which we believe will not alter the favorable clinical profile of torcetrapib/atorvastatin in the treatment of cardiovascular disease.

"We would like to underscore that our studies are far from complete, and the early results cover less than 25 percent of all the patients in the entire clinical program. With a new abstract being posted today we want to ensure that these results are put in the appropriate perspective. No final conclusions on the efficacy and safety of torcetrapib/atorvastatin can be drawn until we complete the lipid and imaging studies and do the accompanying statistical analysis. The torcetrapib/atorvastatin trials completed to date vary in duration and size, and preliminary data at this stage may not represent the final results when Phase 3 is completed."

The next release of clinical trial results will occur in March at the American College of Cardiology meetings, when the results of three vascular imaging studies will be released.

The abstract for the torcetrapib/atorvastatin study in patients with heterozygous familial hypercholesterolemia is being posted today on the website of the American Heart Association at http://scientificsessions.americanheart.org/portal/scientificsessions/ss.

The information contained in this release is as of October 31, 2006. The Company assumes no obligation to update any forward- looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about a product candidate, including its potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for the product candidate as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and in its reports on Form 10-Q and Form 8-K.

Pfizer Inc
http://www.pfizer.com/