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25 February 2009

Pfizer reading tea leaves

A changing political climate may have contributed to the world's biggest drugmaker pulling the plug on two drugs in late-stage testing.

A changing political climate may have contributed to the world's biggest drugmaker pulling the plug on two drugs in late-stage testing.

On Tuesday Pfizer Inc. said it is ending development of two compounds to treat fibromyalgia and generalized anxiety disorder that had been in final human testing in order to shift funding and staff to other experimental drugs with more potential.

"This is Pfizer reading the tea leaves" of health care under the Obama administration in deciding there is not enough money to be made on the two drugs, said analyst Steve Brozak of WBB Securities. "You'll probably see more of these (financially based) decisions, not just with Pfizer, but with all of the pharmaceutical companies." With both disorders poorly understood, he said, it's even harder than usual to show a new drug would offer significant benefit over the existing ones.

The administration's recently enacted stimulus plan includes funding to provide information comparing the effectiveness of competing drugs, something that has been generally opposed by the pharmaceutical industry.

Pfizer said it decided to halt further testing of the compounds after reviewing its existing and experimental primary-care drugs.

Not meeting an unmet need
"They're not products that really meet an unmet medical need," spokeswoman Kristen Neese told The Associated Press. "We'd rather devote our resources to other areas." Neither compound had been seen as a likely blockbuster because other drugs to treat those conditions already are on the market.

However, drug companies generally spend hundreds of millions of dollars by the time a drug reaches final human testing, and Pfizer needs every new drug it can get. Its cholesterol treatment Lipitor, the world's top-selling drug with nearly $13 billion in global annual sales - more than one-fourth of Pfizer's total revenues - is expected to lose patent protection in November 2011.

To address that problem, New York-based Pfizer plans to diversify its product and research portfolios by buying rival drugmaker Wyeth, which is a leader in vaccines, consumer health products and biotech drugs, along with traditional pills. Wyeth, of Madison, New Jersey, also has state-of-the-art technology for manufacturing complex biotech drugs, which are produced in living cells.

The cash, debt and stock deal, originally valued at $68 billion, has dropped somewhat in value as the price of Pfizer shares has fallen since the deal was announced on January 16.

Pfizer's compound for fibromyalgia, a poorly understood pain-and-fatigue ailment, was known by the chemical name esreboxetine.

The treatment for the psychiatric condition generalized anxiety disorder was known only by the designation PD 332,334.

Pfizer said it reviewed results from the first late-stage study for PD 332,334 and all the data for esreboxetine, "along with current market dynamics", before making the decision.

No significant benefit
"While confident in the safety of these compounds, we don't believe that they provide significant benefit over other therapies" on the market, Pedro Lichtinger, president and general manager of Pfizer's Primary Care Business Unit, said in a statement.

Pfizer's own Lyrica, originally approved for epileptic seizures, became the first drug approved for fibromyalgia in the US in June 2007. Then rival Eli Lilly & Co.'s Cymbalta, an antidepressant, won US approval as a treatment for fibromyalgia in June 2008, and Forest Laboratories Inc. and Cypress Bioscience Inc. received approval for their drug Savella in January.

Cymbalta was approved to treat generalized anxiety disorder two years ago. Other psychiatric drugs, while not specifically approved for generalized anxiety disorder, also are used to treat it.

Pfizer said it will continue to pursue approval for using Lyrica to treat generalized anxiety disorder, a chronic condition with symptoms including persistent anxiety, exaggerated worry and tension that impairs daily function.

"Our goal is to use our resources efficiently and effectively to continue to deliver medical innovations," Lichtinger said.

To boost its research productivity, Pfizer last fall narrowed the number of diseases on which it is doing new research, and set up units focused on a single therapy area. Each has its own chief scientific officer, who decides which experimental compounds advance into risky and expensive human testing.

Pfizer said it is notifying all doctors and other staff participating in patient testing of the two cancelled drugs to determine "the best course of action for their patients".

(Sapa, February 2009)

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