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Testim Gel Normalizes Testosterone Levels, Improves Sexual Function as Compared to Transdermal Patch

CHICAGO and NORRISTOWN, Pa., April 29 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc., today announced clinical data showing that Testim™, the company's new testosterone gel, normalized testosterone levels in more hypogonadal aging males with corresponding improvements in sexual function, body composition and mood, when compared to patients treated with a transdermal patch. The results of the study, which was the largest and most definitive placebo-controlled testosterone replacement study ever conducted, were presented today at the annual meeting of the American Urological Association (AUA) in Chicago, Illinois.

The 90-day study, involving 406 hypogonadal men with a mean age of 58 years, compared the pharmacokinetics (PK) and effectiveness of Testim gel at 50 and 100 mg/day, to a commercially available transdermal patch and placebo gel. Blood samples were taken over a 24 hour period to measure serum testosterone levels, and the effect of normalizing serum testosterone levels on body composition, sexual function, mood and bone mineral density were also assessed. Significantly more patients treated with Testim gel had their testosterone levels normalized, with significantly greater improvements in lean body mass, spontaneous erections, sexual desire and sexual performance. Testim gel was well tolerated, while patients treated with the transdermal patch reported a high incidence of application site reactions.

"Given the enhanced treatment effects and positive tolerability profile, the results of this study indicate that Testim gel offers an effective, long-term treatment option for many of the debilitating physical and psychological symptoms associated with age related hypogonadism, including erectile dysfunction and decreased libido, loss of muscle mass and an increase in body fat, and mood disturbances such as depression," said Christopher P. Steidle, M.D., clinical associate professor of urology, Indiana University School of Medicine at Fort Wayne, lead author of the study and one of the key investigators in the Testim development program.

"This large placebo-controlled trial is the first definitive study documenting the link between normalizing testosterone and symptom improvement. Much progress has been made recently in the development of new products to treat erectile dysfunction that is the result of poor circulation. This study shows that many men who suffer from erectile dysfunction also have low testosterone and that normalizing testosterone will have an important beneficial impact on their sexual function," added Dr. Steidle.

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 50 experience hypogonadism and its many symptoms due to a marked decline in the production of testosterone. About four to five million American men and about three million European men suffer from hypogonadism. Currently, only about two percent of patients with hypogonadism have been diagnosed and are receiving treatment with testosterone replacement therapy.

"Testim offers the highest levels of sustained, consistent delivery of testosterone into the blood compared with any other commercial testosterone replacement product, and this study shows there is a direct correlation between consistently higher levels of testosterone and improved benefits in treatment," said Gerri Henwood, president and chief executive officer of Auxilium. "We are very pleased that the largest placebo-controlled study ever conducted for testosterone replacement therapy provides further evidence that Testim gel is an effective treatment for the millions of men affected by low testosterone levels."

Testim was developed by Auxilium Pharmaceuticals and launched in the U.S. in February 2003. Testim is being marketed in the U.S. by Auxilium and its professional sales force, and is likely to be marketed in Europe and other parts of the world through partnering or licensing agreements. Testim uses a proprietary topical drug delivery technology licensed from Bentley Pharmaceuticals, Inc. .

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/.

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