Preliminary Phase III results of Pfizer's experimental cholesterol therapy torcetrapib in combination with the firm's blockbuster statin Lipitor (atorvastatin) showed patients experienced an average increase in systolic blood pressure of two millimeters compared to the atorvastatin alone arm.

Pfizer told "The Pink Sheet" DAILY Oct. 31 that because the results, which were presented at an American Heart Association session, are preliminary, the firm does not view them negatively.

"This is a very early snapshot, and the data must be fully analyzed when the Phase III trial is complete," the company said.

Complete results are slated for presentation at the American College of Cardiology meetings in March 2007, the same time three torcetrapib vascular imaging studies will be released.

Pfizer also reconfirmed it would file an NDA for torcetrapib in the second half of 2007, as previously stated.

"We don't believe [the early results] will impact the cardiovascular profile of torcetrapib/atorvastatin," which has been positive, the firm added.

The firm noted that preliminary results cover only 25% of patients in the clinical trial.

The early data also provided some promising results for torcetrapib. Patients taking the torcetrapib/atorvastatin combination saw HDL cholesterol levels rise by 56% and LDL cholesterol drop by 27% compared to the atorvastatin arm.

During Pfizer's third quarter earnings call Oct. 19, Global Research & Development President John LaMattina said the torcetrapib NDA submission would mark the beginning of a "dialogue" between Pfizer and FDA.

The "filing does not...anticipate a one-year approval for this compound because the FDA has never agreed to approval on imaging alone," he said.

"FDA has made it very clear that they are not bound to approval on imaging alone and are interested as well in the morbidity and mortality studies, which won't be out until late 2009."

- Jonathan M. Block (j.block@elsevier.com)

Torcetrapib Phase III Preliminary Results Offer Mixed Snapshot

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