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More Comments-Pfizer's AIDS Drug Maraviroc Wins U.S. Approval
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By Elizabeth Lopatto and Luke Timmerman
Aug. 6 (Bloomberg) -- Pfizer Inc., the world's biggest drugmaker, won U.S. approval for maraviroc, the first new type of medicine in a decade to treat the virus that causes AIDS, sending the company's shares to their biggest gain in more than a year.
The drug was cleared by the Food and Drug Administration for patients who have failed to reduce the levels of the human immunodeficiency virus with other treatments, Pfizer said today in a statement.
Maraviroc, to be sold under the name Selzentry, will provide an alternative for thousands of Americans with drug-resistant forms of HIV. Analysts say it may generate $145 million in sales next year. The drug will cost about $900 a month wholesale, comparable to other HIV treatments, Pfizer said. The New York- based company said it expects maraviroc to be available in the U.S. by the middle of next month.
``It's clearly an important new medicine for many patients with HIV in need of new therapies,'' said Robert Hazlett, an analyst with BMO Capital Markets in New York, in a telephone interview. He rates Pfizer shares ``market perform'' and doesn't own any.
An FDA advisory panel recommended in April that the agency make the drug available quickly to the 25,000 to 40,000 people who may benefit because their infections resist other treatments. Pfizer also needs to conduct additional studies on maraviroc's side-effects and on which population groups ought to use it, the panel said.
No Unusual Deaths
``This is an important new product for many HIV-infected patients who have not responded to other treatments and have few options,'' said Steven Galson, the director of the FDA's Center for Drug Evaluation and Research, in a statement.
The FDA found no unusual deaths tied to maraviroc. People who took the drug were more likely to develop flu-like illnesses or herpes. The product's prescribing information includes a boxed warning about liver damage and a statement about the possibility of heart attacks, the FDA said in a statement.
Pfizer said on June 20 that the FDA had delayed approval of the drug because of undisclosed issues with its labeling.
The shares rose 60 cents, or 2.6 percent, to $24.11 at 4:01 p.m. in New York Stock Exchange composite trading. The stock hasn't risen that much in a day since July 24, 2006, when the shares gained 4 percent.
The medicine is the first in a new class that blocks the CCR5 receptor, a chemical portal used by HIV to get into healthy cells. The drug changes the shape of the entryway, making it impossible for HIV to get in.
Maraviroc will be given to patients as an oral pill to be taken twice a day, Pfizer spokesman Ray Kerins said by telephone. It must be given in combination with other HIV medications, he said in an e-mail.
Monogram Test
About half of the 1 million people in the U.S. with HIV are infected with a form of the virus that uses the CCR5 entryway. Patients will have to get a test, available from Monogram Biosciences Inc. of South San Francisco, California, to determine whether their type of HIV could be targeted by the drug. The test, called Trofile, is 90 percent accurate.
Monogram retains commercial rights to Trofile in the U.S., and Pfizer will sell it outside the U.S., said Alfred Merriweather, Monogram's chief financial officer, in a telephone interview.
Monogram hasn't announced the price of Trofile, although it sells another HIV diagnostic test for $1,700, Merriweather said. The company's HIV-testing products generated $45 million in 2006.
``This has the potential over a couple years to double our HIV business,'' Merriweather said.
Possible Barrier
The need for a diagnostic test may create a barrier for physicians to prescribe Selzentry, analyst Hazlett said. Another HIV medicine, Isentress from Merck & Co., could be approved by the FDA in October and might appeal to a broader market of patients, Hazlett said.
Two other drugs in the same class as maraviroc were sidetracked by dangerous side effects. GlaxoSmithKline Plc halted trials of its aplaviroc because of liver damage among patients, and Schering-Plough Corp.'s vicriviroc was linked to lymphoma.
Studies ``do not indicate that maraviroc is associated'' with liver damage or with cancers, the FDA staff said in an analysis of the drug.
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