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Pfizer nears Maraviroc HIV FDA application
  Friday, September 08, 2006 BY GEORGE E. JORDAN Newark Star-Ledger Staff
Pfizer yesterday said it will apply later this year for Food and Drug Administration approval of a new class of HIV/AIDS drugs.
The tablet, called Maraviroc, doesn't target HIV, the virus that causes AIDS, but attempts to block the virus from infecting healthy cells.
It belongs to a novel class of HIV/AIDS drugs, called CCR5 entry inhibitors, which tinker with the body's immune system. It would be used in combination with existing treatments, called antire trovirals, which people living with HIV rely on to prolong their lives.
"It's in the final stages of clinical tests," said Joseph Feczko, senior vice president and chief medical officer of the New York-based firm, in remarks yesterday in Seoul, Korea. "We are hopefully going to file this for registration before the year-end, hopefully around the world."
Wall Street analysts project a CCR5 drug would generate $750 million in sales after four years on the market.
Pfizer is in a race to win FDA approval of the drug with Schering- Plough, which is developing its own CCR5 pill called Vicriviroc.
"We have a compound that could save peoples lives," said Catherine Strader, Schering- Plough's chief science officer. "It's very potent and we believe its safe. One pill a day."
Drugmakers have faced scientific hurdles in developing CCR5 inhibitors. Researchers still don't know the long-term health effects of the drugs, which have been linked to liver problems and cancer.
HIV, which stands for human immunodeficiency virus, has in fected 65 million people and killed nearly 25 million since June 1981, when the first cases were reported in the United States. People living with the disease must rely on powerful drugs, called antiretrovirals, that show the progress of the disease.
HIV/AIDS patients and their physicians are eager for new treatments, because HIV is becoming increasingly resistant to the 27 FDA-approved antiretroviral drugs, which are typical administered in a three-drug cocktail that fights HIV once it has infected healthy cells.
Human cells have locks on their surface -- scientists call them re ceptors -- that are like locks into which a virus must insert its key to gain entry.
HIV most often uses the CCR5 receptor to gain entry to healthy cells, turning them into virus-producing factories that can churn out more than 1 million copies a day.
CCR5 entry inhibitors are designed to slam closed the doorway HIV uses to enter healthy cells in the first place.
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