Pfizer ends cholesterol-drug development: Halts Clinical Trial

Torcetrapib tests halted on patient-safety concerns:

BOSTON-- Pfizer Inc. said it has halted clinical trials and development of its
HDL, cholesterol by 55% to 60% and lowered bad, or LDL, cholesterol by 10% to 15% relative to patients who were taking only Lipitor.
Joseph Feczko, Pfizer's chief medical officer, said then that the data supported "our fundamental premise: this innovative medicine really can 'do both' and manage total cholesterol successfully."

At the same time, the company said data showed that patients using the torcetrapib/Lipitor combination experienced slightly higher systolic blood pressure than those who took Lipitor alone. Pfizer emphasized the data at that point were not yet complete and still needed further analysis.
According to published reports Sunday, Pfizer was conducting a test of 15,000 patients, half of which took the drug combination with the rest taking Lipitor alone. Eighty-two of the patients taking the combination died, while 51 died taking just Lipitor, according to reports.

The drug company had been developing the combination as a potential successor to Lipitor, which loses patent protection as soon as 2010. Lipitor is the world's top-selling branded prescription drug, with 2005 sales of $12.9 billion, according to IMS Health.

In its latest statement, Pfizer's chief executive, Jeffrey B. Kindler, said the recommendation from the monitoring board was "surprising and disappointing."
Nonetheless, the executive affirmed Pfizer's financial estimates for 2006.
The company expects "high-single-digit average growth" in adjusted earnings over the next two years. A survey of analysts by Thomson First Call produced consensus estimates of profit of $2.05 a share for 2006 and $2.17 for 2007, compared with $2.02 in 2005.

It said it expects revenue in 2007 and 2008 to be comparable with the 2006 figure and then return to growth in 2009. First Call's estimate for 2006 is $48.07 billion against 2005's $51.3 billion.
And it affirmed that it expects to introduce about six new products a year starting in 2010.

The company last week said it planned to cut about 20% of its sales force as part of its restructuring effort.

Pfizer shares closed on Friday up 37 cents, or 1.4%, at $27.86.

What is and how does it work?
Torcetrapib is a cholesterol lowering drug based on the strategy of actively inhibitiing cholesteryl ester transfer protein (CETP). CETP is a plasma glycoprotein
that facilitates the transfer of cholesteryl esters from HDL cholesterol to apolipoprotein B–containing lipoproteins.

Humans with CETP deficiency due to molecular defects in the CETP gene have markedly elevated plasma levels of HDL cholesterol ("good cholesterol")and apolipoprotein A-I,
leading to the concept that CETP inhibition might increase HDL cholesterol
levels.
In animal models, inhibition of CETP by monoclonal antibodies, antisense oligonucleotides,small molecules, or vaccine induced antibodies has resulted in increased HDL cholesterol levels. In addition, a small-molecule inhibitor
of CETP has been shown to increase HDL cholesterol levels to a moderate extent in healthy persons with normal HDL cholesterol levels.

The clinical trial was designed to examine the effects of this novel CETP inhibitor, (torcetrapib).