WSJ: "Pfizer Is Dealt Setback On HIV-Drug Approval"

Pfizer Is Dealt Setback On HIV-Drug Approval
By JENNIFER CORBETT DOOREN and AVERY JOHNSON
June 21, 2007; Page A13

Pfizer Inc.'s pipeline was dealt a surprise blow last night, when the FDA delayed the approval of one of its most interesting drug prospects, a new type of medicine for HIV.

It was a significant setback, and came on the heels of another announcement by the New York-based drug maker yesterday that it would halt some studies of a cancer drug in late-stage development. The FDA had been expected to approve the HIV drug, called maraviroc, this week, after a panel of reviewers endorsed it in April. Instead, the FDA issued a so-called approvable letter, which means that the agency believes a product is worthy of approval, but usually needs additional information.

Wall Street has been closely watching Pfizer's pipeline, and yesterday's two signs could be bad omens for Chief Executive Jeffrey Kindler's turnaround plan, which hinges on injecting life into lackluster labs. The big issue: As soon as 2010, Pfizer could lose the nearly $13 billion in sales it brought in last year from cholesterol-fighter Lipitor.

Maraviroc alone wasn't meant to plug that hole; some analysts only saw peak sales at about $500 million a year. But the medical need for new drugs to fight HIV is high as more patients resist treatment, and the blow is symbolic for Pfizer. Earlier yesterday, Pfizer said it halted some studies of lung-cancer drug PF-3512676 when it didn't show effectiveness, after trumpeting its cancer pipeline at a large medical meeting earlier this month.

If approved, maraviroc would be the first drug to inhibit a pathway that HIV uses to infect cells rather than treating the virus itself. Maraviroc blocks a receptor known as CCR5 in order to prevent HIV infection. However, in some patients HIV uses another receptor, known as CXCR4, to enter cells, and maraviroc wouldn't work in those cases. Pfizer has proposed using maraviroc in patients with advanced HIV infection or AIDS who have failed treatment with other types of drugs, which is estimated at about 40,000 patients in the U.S. The FDA had granted it a fast-track review.

Pfizer said it will work with the agency quickly to address questions and finalize the product labeling. The FDA isn't asking for any more clinical trials, and the drug could still come to market as soon as the third quarter of this year, when some on Wall Street expected it. Pfizer also pledged to make the drug available to HIV patients through an access program in 30 countries, which isn't affected by the FDA's decision.

The FDA had said it was concerned about possible liver damage, heart problems and infection; GlaxoSmithKline PLC stopped working on a CCR5 drug after it was found to cause liver problems. The FDA couldn't be reached for comment last night.

Pfizer shares were off 50 cents, at $25.71, in 4 p.m. New York Stock Exchange composite trading yesterday.