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Pfizer Torcetrapib Filing To Start ‘Dialogue,’ Not Necessarily Standard Review

Executive Summary

Pfizer views its planned filing for its investigational HDL/LDL cholesterol combination therapy torcetrapib/Lipitor as the initiation of a dialogue between the company and FDA, not necessarily the start of a standard review

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Torcetrapib BP increase increases

Preliminary results of a Phase III study of Pfizer's torcetrapib/Lipitor combination product show an average increase in systolic blood pressure of two mmHg for the HDL/LDL cholesterol combination product when compared to atorvastatin alone. "Our overall Phase III results to date...also show an average increase in systolic blood pressure of approximately one [mmHg] above the two-to-three millimeter range that was observed in Phase II studies, which we believe will not alter the favorable clinical profile of torcetrapib/atorvastatin," Pfizer Chief Medical Officer Joe Feczko says in an Oct. 31 statement. Pfizer expects to file an NDA for the compound in 2007, but has said the filing "does not anticipate a one-year approval for this compound" (1"The Pink Sheet" Oct. 23, 2006, p. 5)...

Torcetrapib BP increase increases

Preliminary results of a Phase III study of Pfizer's torcetrapib/Lipitor combination product show an average increase in systolic blood pressure of two mmHg for the HDL/LDL cholesterol combination product when compared to atorvastatin alone. "Our overall Phase III results to date...also show an average increase in systolic blood pressure of approximately one [mmHg] above the two-to-three millimeter range that was observed in Phase II studies, which we believe will not alter the favorable clinical profile of torcetrapib/atorvastatin," Pfizer Chief Medical Officer Joe Feczko says in an Oct. 31 statement. Pfizer expects to file an NDA for the compound in 2007, but has said the filing "does not anticipate a one-year approval for this compound" (1"The Pink Sheet" Oct. 23, 2006, p. 5)...

Pfizer Cost-Cutting: Details Are Sketchy, But Sales Force Is On The Table

Pfizer CEO Jeffrey Kindler has opened the door to sales force reductions as part of the firm's latest cost-cutting initiative, announced Oct. 1

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