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Auxilium Receives U.S. FDA Approval to Market Testim™ Testosterone Replacement Gel

NORRISTOWN, PA -- November 1, 2002 -- Auxilium Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration (FDA) has granted approval for Testim™, a patented testosterone replacement therapy gel.

Testim is approved for use in treating men with low testosterone levels.

Testim is a novel, topical gel formulation that supplements low levels of testosterone in men. Abnormally low levels of testosterone are linked to a decline in energy, decreased muscle mass, reduced bone density, decreased libido and sexual function, fatigue and depression.

"We look forward to the launch of Testim and the opportunity to make a difference in the lives of the many men suffering from the effects of abnormally low levels of testosterone," said Gerri Henwood, chief executive officer of Auxilium. "We deeply appreciate the efforts of our investigators, advisors, consultants and the talented group of professionals who represent the core strengths of Auxilium and who made this important milestone possible."

Testim, Auxilium's first commercial product, will be marketed in the United States by Auxilium and its professional sales force. Regulatory clearance for Testim was received only 22 months after initial product development.

The Testim clinical trials were the largest ever conducted in testosterone replacement therapy. They involved 644 hypogonadal men treated at more than 70 centers in six countries. Auxilium found that Testim normalizes testosterone levels and improves sexual function and other symptoms associated with low testosterone. Auxilium's worldwide development program for Testim also included the largest placebo-controlled testosterone replacement study ever conducted, with over 400 patients at 43 centers in the U.S.

Auxilium has focused on significant market opportunities related to unmet healthcare needs in an aging population. Auxilium will continue to identify and develop compounds that can feature patent-protection and expand its growing franchise in the areas of male health and urology.

Auxilium Pharmaceuticals, Inc., was founded in 1999 to develop and market pharmaceutical products that improve health and restore function as we age.

Auxilium has assembled a team of leading healthcare professionals and medical advisors with superior capabilities in R & D and decades of pharmaceutical industry experience. The Company is seeking to expand its portfolio by licensing additional products for development or co-promotion. For additional information, visit <http://www.auxilium.com>.

SOURCE Auxilium Pharmaceuticals, Inc.

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