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Womans Health

Saturday, January 10, 2004
Female sex-drive drug is in late stages of testing

Procter & Gamble is in the advanced stages of testing a drug to improve the sex drive in women that executives say may be a "blockbuster" seller.

Company officials say the first-of-its-kind drug, called Intrinsa, is intended for women suffering from a loss of sexual desire as a result of menopause or surgery.

The drug is being developed as a skin patch containing testosterone, a hormone that affects sexual desire in women. Company officials say if the Food and Drug Administration approves the patch, the prescription drug could be on the market sometime in 2005.

Cincinnati-based P&G has six rival companies also working on female sexual dysfunction drugs, but no others have reached the advanced stage of clinical trials, called Phase III testing, according to the trade group Pharmaceutical Research and Manufacturers of America.

The stakes are large, as an estimated 9 million to 12 million women in the United States and Europe suffer from the condition, called hypoactive sexual desire disorder.

Pfizer is also testing its Viagra product on women, but for use in treating arousal disorder, a separate malady. A spokesman said those trials are in Phase II.

Some experts estimate that any drug for female sexual dysfunction that proves effective could achieve sales of more than $1 billion a year. Pfizer was first to market with a drug addressing men's sexual impotence -- Viagra, now worth more than $1 billion in sales a year -- in the late 1990s.

Being the first to develop a class of drug is critical in competing and dominating the market, said David Williams, an analyst with Swiss American Securities Inc. in New York. He said pharmaceuticals are an attractive business because they promise healthy profit margins.

"Being first in class gives you an advantage -- once they're comfortable you have an effective product, patients and doctors kind of get married to a brand," he said.

The drug's potential is tremendous because there is currently no medication approved by the FDA for the condition, said Dr. Margery Gass, a professor at the University of Cincinnati College of Medicine. Gass participated in the clinical trials as an investigator.

"Viagra has led the way in making people realize this affects an important part of people's lives," she said. "If you've had a healthy sexual life and it's taken away, that causes discord in relationships. It's a quality-of-life issue."

Gass noted that Intrinsa is different from Viagra in that it addresses the lack of desire, as opposed to problems with physical ability.

P&G officials stress that the federal government will ultimately decide whether they can market the new drug, but say they are encouraged by the results and believe they will submit a strong application to the regulatory agency.

"We think our clinical trial data is very promising," said spokeswoman Mary Johnson. She declined to say exactly when Phase III trials would be completed.
P&G's pharmaceutical president, Mark Collar, told analysts in Cincinnati last month that Intrinsa had "blockbuster potential."

P&G acquired the license for Intrinsa from Watson Laboratories in 1997 and has coordinated research and trials from its Healthcare Research Center in Mason, Ohio. The company controls the patent as well as marketing and development rights.

Phase III is the final testing stage that occurs before the FDA reviews a pharmaceutical for approval as a new prescription drug.

P&G resists comparisons to a female version of Viagra, noting the drug works differently by restoring testosterone that affects desire rather than improving blood flow to sexual organs.


By ALEXANDER COOLIDGE
SCRIPPS HOWARD NEWS SERVICE

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> Healh Topics

What is Male Erectile Dysfunction or Impotence . read

When Should Testosterone be Used to Treat Erectile Dysfunction:
Safety vs. Effectiveness?

Treatment for prostate cancer with hormone therapy. read

Hormone Deficiency Symptoms

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