AEGiS-PRn: Bentley Pharmaceuticals Reports Auxilium's Announcement of Study Results Demonstrating That Testim(R) Delivered Using Bentley's CPE-215 Technology is Effective in Treating HIV-Positive Hypogonadal Men - Testim(R) Treated Men Experienced Sexual Function Improvement versus AndroGel(R) - PRNewswireImportant note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
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Bentley Pharmaceuticals Reports Auxilium's Announcement of Study Results Demonstrating That Testim(R) Delivered Using Bentley's CPE-215 Technology is Effective in Treating HIV-Positive Hypogonadal Men - Testim(R) Treated Men Experienced Sexual Function Improvement versus AndroGel(R) -

PRNewswire - November 19, 2004


EXETER, N.H., Nov. 19 /PRNewswire-FirstCall/ -- Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company focused on advanced drug delivery technologies, which also manufactures and markets a growing branded and generic product line in Europe, today announced that Auxilium Pharmaceuticals (Nasdaq: AUXL) has reported top-line study results, comparing Testim(R), which utilizes Bentley Pharmaceuticals' CPE-215 technology, to AndroGel in HIV positive men. Bentley receives a royalty on sales of Testim(R).

The Auxilium study explored the effect of Testim(R) 5g therapy in 48 hypogonadal, HIV positive men who reported that they did not have adequate symptom relief with AndroGel 5g. Auxilium reported that, compared to AndroGel treated men, at the 4-week follow-up, men treated with Testim(R) 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(R) treated group as compared to the AndroGel treated group. Auxilium reported that these improvements in sexual function resulted in significantly fewer Testim(R) treated men requiring titration to a higher dose compared to men treated with AndroGel (30% vs 74%, respectively).

"We are pleased and encouraged by Auxilium's study data, which we believe further validate the effectiveness of Bentley's proprietary drug delivery technology," stated James R. Murphy, Chairman and CEO of Bentley. "We look forward to bringing CPE-215's benefits to bear for the effective, convenient delivery of a wide range of drugs."

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(R) 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 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.

Bentley Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on advanced drug delivery technologies and pharmaceutical products. Bentley's proprietary drug technologies enhance or facilitate the absorption of pharmaceutical compounds across various membranes. Bentley also manufactures and markets a growing portfolio of generic and branded pharmaceuticals in Europe for the treatment of cardiovascular, gastrointestinal, infectious and neurological diseases through its subsidiaries, Laboratorios Belmac, Laboratorios Davur and Laboratorios Rimafar; and manufactures and sells active pharmaceutical ingredients through its subsidiary, Bentley API.

Copies of Bentley Pharmaceuticals' press releases and other information may be obtained through Bentley's web site at http://www.bentleypharm.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This press release contains forward looking statements, including without limitation, statements regarding the interpretation of the clinical results, and the prospects for Testim(R) and for our proprietary drug delivery technologies. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from future results expressed or implied by such statements. Factors that may cause such differences include, but are not limited to risks associated with the timing and results of clinical trials, efficacy and safety of our products, the timing and nature of regulatory approvals, development and commercialization of our products, competition from other manufacturers of proprietary pharmaceuticals, intellectual property litigation, and other uncertainties detailed in Bentley's most recent Annual Report on Form 10-K and its other subsequent periodic reports filed with the Securities and Exchange Commission. Bentley cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and Bentley undertakes no obligation to update or revise the statements, except as may be required by law.

SOURCE Bentley Pharmaceuticals, Inc.

Web Site: http://www.bentleypharm.com


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