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Men Given Testim Exhibit Greater Testosterone Absorption Than Those Given Androgel

NORRISTOWN, Pa., April 23 /PRNewswire/ -- A recent study of hypogonadal men found that patients treated with Testim(TM), a new 1% testosterone topical gel marketed by Auxilium Pharmaceuticals, Inc., absorbed 30% more testosterone dose for dose than patients treated with AndroGel(R), the other commercially available testosterone gel. The results of the study are reported in the April 2003 issue of Biopharmaceutics & Drug Disposition (Volume 24, Issue 3, pp. 115-120).

In the study, 29 men with hypogonadism (testosterone deficiency) all received a single dose (50 mg of testosterone) of Testim and AndroGel seven days apart. Blood samples were collected before and at numerous intervals after dosing during a 48-hour period to evaluate the pharmacokinetic profiles of Testim as compared to AndroGel. The results of the study found that the serum concentration of testosterone was 30 % greater following application of Testim.

"This comparative study found that testosterone levels were significantly and consistently higher when patients were treated with Testim," said Thomas Marbury, M.D., clinical associate professor, University of Florida and president, Orlando Clinical Research Center, principal investigator of this study. "And higher levels of testosterone offer greater clinical benefit for many of the debilitating side effects of low testosterone levels that include decreased sexual desire and function, fatigue and loss of energy, decreased muscle mass, reduced bone density and depression."

Testim was developed by Auxilium Pharmaceuticals and utilizes a proprietary topical drug delivery technology licensed from Bentley Pharmaceuticals, Inc. (AMEX:BNT) that promotes better absorption of drugs across dermal membranes.

"The results of this study show that Testim's unique proprietary gel formulation provides increased absorption of testosterone," said Gerri Henwood, president and chief executive officer of Auxilium. "Previously published studies involving Testim(TM) gel found that higher levels of testosterone absorption correspond to improved benefits in sexual function, body composition, mood and other areas. The results of this study further indicate that Testim offers many important advantages for men suffering from the debilitating side effects of low testosterone levels."

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 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 was launched in the U.S. in February 2003, and a European application for Testim was filed in April 2002. 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.

Source: Auxilium Pharmaceuticals, Inc.

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