Replies to post #36658 on Biotech Values

[DewDiligence]

>Torcetrapib lipid results are fairly impressive but a CV drug that raises BP, hmmm....not good. I would not like to predict the outcome studies. I recall VIOXX raising BP about the same!<

An increase of 2-3mm Hg (the old guidance) is not that bad, but the problem for investors is that the goal posts keep moving. Now PFE says the increase is actually 3-4mm, which is getting to the level docs might consider clinically relevant. If the mean increase ends being as high as 5mm, I think the product is doomed. JMHO, FWIW

[DewDiligence]

More on the same PFE story…

http://online.wsj.com/article/SB116232576178209242.html

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Pfizer Cholesterol Treatment
May Also Raise Blood Pressure

By SCOTT HENSLEY
October 31, 2006 6:14 p.m.

Pfizer Inc. said new data showed its leading experimental drug to boost good cholesterol also raised patients' blood pressure more than previously reported, a development that further clouded the outlook for the most important medicine in the company's research pipeline.

The New York-based drug maker is spending more than $800 million on clinical tests of the drug called torcetrapib, which raises HDL, or good cholesterol, and that doctors hope may slow or reverse clogging of heart arteries. But the experimental medicine carries unwanted baggage: a tendency to increase blood pressure in patients already at risk for heart disease.

A preliminary analysis of recently gathered clinical data showed that torcetrapib raised systolic blood pressure an average of 3 to 4 millimeters of mercury. Earlier studies indicated an increase of 2 to 3 millimeters. Systolic pressure is the first of the two numbers to describe blood pressure. Normal systolic pressure is 120 millimeters of mercury.

Because increased blood pressure raises risks for heart attacks and strokes, the side effect is particularly worrisome for a drug that aims to help people avoid cardiovascular illness. Pfizer says the recent analysis represents less than 25% of the data the company has collected about torcetrapib so far. Further, the company points out that torcetrapib showed profound effects in raising good cholesterol while reducing bad cholesterol when taken in combination with Lipitor. Pfizer's cholesterol-fighter Lipitor is the world's best-selling medicine with $12.19 billion in sales last year.

For Pfizer the stakes with torcetrapib are high. Lipitor may face generic competition as early as 2010, and the company has bet on torcetrapib to take up the slack once Lipitor fades away. "We're still very positive about the drug," said Joseph Feczko, Pfizer's chief medical officer in an interview. He acknowledged the blood pressure increase but said scientists at the company still think the drug will have a positive "net impact" for patients by raising their good cholesterol and improving their clogged arteries. "But we can't know that for sure until we see the imaging trials," he said.

In March, the company expects to learn the results of ultrasound pictures taken from inside the blood vessels feeding the heart in patients taking torcetrapib and Lipitor or Lipitor alone. Results of two other studies looking at other blood vessels will also be known then. The degree to which torcetrapib stabilizes or reduces the volume of cholesterol plaque in these pictures could help determine if the drug's beneficial effects outweigh its risks.

"This level of blood pressure increase is clearly a cause for concern," said Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and lead investigator of an ultrasound imaging study of the coronary arteries of nearly 1200 patients. "What we now have to determine is whether the very large increase in HDL along with the modest decrease in LDL provides benefits that exceed the risks associated with a blood pressure increase."

Pfizer discussed the blood pressure phenomenon after releasing preliminary data from a study of 400 people with a form of very high LDL choleseterol that runs in families. Torcetrapib in combination with Lipitor raised "good" cholesterol 56% and lowered "bad" cholesterol 27% more than patients taking Lipitor alone. The average increase in systolic blood pressure in the treated patients was about 2 millimeters of mercury. This study will be presented at the American Heart Association's annual scientific meeting in Chicago on November 15.

Pfizer shares fell 55 cents, or 2%, to $26.65 on the news. Tony Butler, pharmaceuticals analyst with Lehman Brothers, said the blood pressure increase raises the bar the company will have to overcome to win approval of the drug. Sill, he said there is "reasonable probability of a successful outcome" for Pfizer if the imaging studies show the drug works in stabilizing of reducing plaques.
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