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PRNewswire - November 17, 2004
NORRISTOWN, Pa., Nov. 17 /PRNewswire-FirstCall/ -- Auxilium Pharmaceuticals (Nasdaq: AUXL), a specialty pharmaceutical company that develops and markets products for urologic and sexual health, today announced top line study results comparing Testim to AndroGel in HIV positive men.
This study explored the effect of Testim 5 g therapy in 48 hypogonadal, HIV positive men who reported that they did not have adequate symptom relief with AndroGel 5 g. Compared to AndroGel treated men, at the 4-week follow-up, men treated with Testim reported a statistically and clinically significant improvement in their sex drive, erectile function, and satisfaction with sex life as well as being more satisfied with androgen therapy. Additionally, the investigators rated their overall satisfaction with androgen therapy significantly higher in the Testim treated group as compared to the AndroGel treated group. These improvements in sexual function resulted in a significantly fewer Testim(R) treated men requiring titration to a higher dose compared to men treated with AndroGel (30% vs 74%, respectively).
"We believe this study supports Testim's effectiveness in treating the symptoms associated with hypogonadism and demonstrates that Testim offers HIV- positive men with a choice that has been clinically demonstrated in head-to- head studies to have qualities superior to AndroGel. We hope that a treatment option that provides the symptom relief experienced will lead to improved vitality and, more importantly, improved quality of life," said Gerri A. Henwood, chairman and chief executive officer of Auxilium.
Hypogonadism among HIV Positive Men
Hypogonadal men exhibit lower than normal levels of testosterone, resulting in a variety of symptoms including low energy levels, loss of sex drive, decreased sexual performance, loss of muscle mass, reduced bone density, increased body fat, and mild depression.
Symptoms of fatigue, decreased muscle mass, reduced libido, reduced sexual functioning, and depressed mood are often associated with low testosterone (T) levels in hypogonadal, HIV positive men.
About Testim(R)1%
Testim is a marketed, proprietary, once a day, topical 1% testosterone gel that treats hypogonadism by raising testosterone blood levels back to normal. Testim(R) is packaged in a convenient, easy-to-open, single-use tubes. Patients apply Testim(R) once a day to the upper arms and shoulders and its active ingredient, testosterone, is absorbed through the skin and into the bloodstream.
About Auxilium
Auxilium Pharmaceuticals, Inc., founded in 1999, is an integrated specialty pharmaceutical company with a focus on urologic and sexual health. Auxilium markets Testim(R) 1%, a topical testosterone gel, for the treatment of hypogonadism through its 100 person sales and marketing team. The company is developing additional Testim(R) line extensions in addition to a product in Phase II for treatment of Peyronie's Disease as well as other products for urologic and sexual health. For additional information, visit http://www.auxilium.com.
Safe Harbor Statement
In addition to historical facts or statements of current condition, this press release contains forward-looking statements within the meaning of the "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995, including statements regarding the interpretation of clinical results. Forward-looking statements provide Auxilium's current expectations or forecasts of future events. Auxilium Pharmaceutical's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries. For a discussion of the risks and uncertainties which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in Auxilium Pharmaceutical's Form S-1 Registration Statement and Form 10-Q for the quarterly period ended September 30, 2004, each of which is on file with the Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward- looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Auxilium Pharmaceuticals undertakes no obligation to update publicly any forward-looking statement.
SOURCE Auxilium Pharmaceuticals, Inc.
Web Site: http://www.auxilium.com
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