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Testim (Testosterone Gel) Gel For Treatment Of Testosterone Deficiency In Men Now Available In US

NORRISTOWN, PA -- February 4, 2003 -- Auxilium Pharmaceuticals, Inc. today announced the launch of Testim™, a patented testosterone gel. Auxilium received U.S. Food and Drug Administration (FDA) approval to market Testim on October 31, 2002, for use in treating men with low testosterone levels.

Testim is a novel, topical gel formulation that is used to supplement low levels of testosterone in men with hypogonadism, a condition that occurs when a man's body does not produce adequate amounts of testosterone. Testosterone deficiency can lead to a decline in energy, decreased muscle mass, an increase in abdominal fat, reduced bone density leading to an increased risk of osteoporosis, decreased libido, decreased sexual function and impotence, anemia, fatigue, and depression.

"In a randomized, cross-over study in hypogonadal men, Testim was shown to have 30 percent better testosterone absorption dose for dose than was seen with a commercial testosterone gel," said Thomas Marbury, M.D., associate professor, University of Florida and president, Orlando Clinical Research Center, principal investigator of this study.

During the clinical trials of Testim, patients reported a 59 percent increase in sexual activity and a 78 percent increase in days with a spontaneous erection over a 90-day period. Patients also showed an average increase of 3.5 pounds in muscle mass in 90 days with no weight training and without overall weight gain. Initial analysis of long-term data suggests that Testim improves bone mineral density.

"Testim gel is an improved, effective, easy to use new option for the treatment of hypogonadism for the millions of men across the country who suffer from the often life-altering effects of low testosterone levels," said Christopher P. Steidle, M.D., clinical associate professor of urology, Indiana University School of Medicine at Fort Wayne, one of the key investigators of the Testim development program. He continued, "the most exciting part of testosterone replacement therapy is the dramatic and positive feedback you hear from men after they've been on treatment. Testim helps men feel like themselves again."

The Testim clinical trials were the largest ever conducted in testosterone replacement therapy, involving 690 hypogonadal men treated at 74 centers in the U.S. and Europe. 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.

"With the many important advantages of Testim for patients, we believe there is a tremendous opportunity for its success in the marketplace," said Gerri Henwood, president and chief executive officer of Auxilium. "As more men become aware that it is possible to treat many of the debilitating symptoms associated with low testosterone we expect the demand for these treatments to increase and the market for testosterone replacement therapy to continue to grow, exceeding $2 billion by 2008."

About four to five million American men suffer from hypogonadism and currently, only about 2 percent undergo treatment with testosterone replacement therapy. There are many causes of hypogonadism; including damage to the testes or pituitary gland from infection, trauma, radiation, or chemotherapy treatment, as well as congenital abnormalities such as Klinefelter Syndrome, a rare condition that occurs when a man is born with an extra X chromosome. The highest incidence of hypogonadism is seen in men over the age of 50. About 20 percent of men over the age of 50 experience hypogonadism and its many symptoms due to a decline in the production of testosterone.

Testim is Auxilium's first commercial product and is being marketed in the United States by Auxilium and its professional sales force. Regulatory clearance for Testim was received only 22 months after initiation of the first clinical study. Testim utilizes a proprietary topical drug delivery technology licensed from Bentley Pharmaceuticals, Inc. (Amex: BNT).

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 and decades of experience in pharmaceutical R&D and commercialization. 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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