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Pfizer Likely to Seek Approval of New Heart Drug 2006-12-01
By Alex Berenson

Pfizer Likely to Seek Approval of New Heart Drug

Pfizer executives told investors Thursday that they hoped to ask federal regulators next year to approve torcetrapib, a heart drug crucial to the company's future, despite evidence that the drug increases blood pressure.

Pfizer also slightly raised its profit projections for 2006, while promising that it would triple the number of drug compounds in late-stage development by 2009 and introduce four new medicines a year beginning in 2011.

In addition, Pfizer said it would make it easier for the public to track its development program by offering twice-a-year updates on the progress of almost all the drugs in its pipeline.

Shares in Pfizer, the world's largest drug company, rallied more than 2 percent.

Jami Rubin, an analyst at Morgan Stanley, said that investors were hoping that Jeffrey B. Kindler, Pfizer's new chief executive, would be able to cut costs while freeing the company's scientists to bring drugs to market more quickly.

Still, Pfizer shares are trading at a lower price-earnings multiple than other big drug stocks, a sign that investors believe Mr. Kindler has a difficult road ahead, Ms. Rubin said.

''Pfizer is an incredibly-low-expectations story,'' she said.

Pfizer estimated that it would earn at least $2.05 a share in ''adjusted diluted'' earnings for 2006, a nonstandard measure of earnings that excludes certain charges, compared with its earlier estimate of at least $2 a share. Using standard accounting rules, Pfizer projected earnings of at least $1.68 a share.

The executive comments came at an all-day meeting that Pfizer held for investors at its research campus in Groton, which along with a second center nearby in New London is home to 6,000 employees.

At the meeting, senior Pfizer scientists discussed more than 30 research programs, including novel ways to attack schizophrenia, obesity and infectious diseases. The company highlighted its portfolio of cancer drugs, saying that it expected to ask federal regulators to approve several treatments over the next five years, including a drug meant to help the immune system fight tumors.

In addition, Mr. Kindler expressed optimism about the prospects for torcetrapib. The drug, which Pfizer has been developing since 1998, raises so-called good cholesterol. Pfizer expects to sell it both independently and in combination with Lipitor, a Pfizer drug that helps reduce so-called bad cholesterol and is the world's top-selling medicine, with sales of $13 billion expected this year.

Both Pfizer and analysts expect torcetrapib to have several billion dollars in sales annually if it is approved. Clinical trials have already shown that torcetrapib appears to reduce plaque in blood vessels, a crucial contributor to heart attacks and strokes.

But because clinical trials have also shown that torcetrapib can raise blood pressure, independent analysts predict that the Food and Drug Administration will be reluctant to approve torcetrapib without proof that it actually reduces heart attacks and strokes, not just that it cuts plaque. Data that the company hopes will offer that proof will not be available until a 15,000-patient clinical trial is finished in 2010.

Mr. Kindler suggested, however, that Pfizer could file for approval based on data from smaller studies that will be available next year.

''This will be one of the most important compounds of our generation,'' Mr. Kindler said. ''We think we'll have a strong case for approval.''


 
 
 
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