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Bentley Pharmaceuticals (BNT) Reports That Auxilium Pharmaceuticals' Long-Term Study Shows Use Of Testim Testosterone
3/2/2004

EXETER, N.H., March 2 /PRNewswire-FirstCall/ -- Bentley Pharmaceuticals, Inc. , a technology based specialty pharmaceutical and drug delivery company with a growing branded and generic product line in Europe, today reported that Auxilium Pharmaceuticals, Inc. presented long-term clinical data which showed that men with low testosterone (a condition known as hypogonadism) treated with Auxilium's Testim(R) 1%, a patented testosterone gel utilizing Bentley's proprietary CPE-215 drug delivery technology, demonstrated significant improvements in sexual function, mood, body composition (lean body mass), and bone mineral density. The study, which involved 290 men who were treated with Testim 1% (testosterone gel) for more than 12 months, is one of the first to demonstrate that the benefits of testosterone replacement therapy are maintained following more than one year of therapy. The findings were presented on Friday, February 27th at the 4th World Congress on the Aging Male in Prague, Czech Republic.

"We are pleased with the continued progress and uptake of Auxilium's Testim. This data further validates Bentley's proprietary drug delivery technology and we look forward to bringing CPE-215's benefits to bear for superior, convenient delivery of a wide range of drugs," stated James R. Murphy, Chairman and CEO of Bentley.

Following the completion of a 90-day placebo-controlled study involving 406 hypogonadal men with a mean age of 58 years, 290 hypogonadal men continued to receive treatment with Testim 1% in an open-label extension study that lasted an additional 12 months. Testosterone levels were measured in blood samples taken in the morning, and the effects of normalizing testosterone on sexual function, mood, body composition, and bone mineral density were also assessed.

In the 90-day study, treatment with Testim 1% resulted in rapid normalization of serum testosterone levels that continued throughout the 12-month extension study. Patients treated with Testim 1% showed significant improvements in sexual desire and motivation, spontaneous erections, sexual performance, mood, and lean body mass in the 90-day study that were maintained throughout the extension study. Significant improvements in bone mineral density were also demonstrated in the long-term study.

Testim 1% is a novel, topical gel formulation that raises levels of testosterone in men with hypogonadism, a condition that occurs when a man's body does not produce adequate amounts of testosterone. This condition, also known as androgen deficiency, has been estimated to occur in approximately 20% of men over 50 years of age. Men with hypogonadism or androgen deficiency may suffer from a decline in energy, decreased muscle mass, an increase in abdominal fat, decreased libido, decreased sexual function, decreased frequency of erections, anemia, fatigue, depression and reduced bone density that may result in an increased risk of osteoporosis. Currently, less than five percent of patients with hypogonadism have been diagnosed and are receiving treatment with testosterone replacement therapy.

Testim 1% uses a proprietary topical drug delivery technology licensed from Bentley Pharmaceuticals. Testim was developed by Auxilium Pharmaceuticals and launched in the U.S. by its professional sales force in February 2003. After receiving regulatory approval, Testim 1% will be marketed in Canada, and is likely to be marketed in Europe and other parts of the world through partnering or licensing agreements.

About Bentley:

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.

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: The statements which are not historical facts contained in this press release are forward-looking statements that involve certain risks and uncertainties including but not limited to risks associated with identifying suitable drugs for drug delivery technologies, expanding generic and branded drug operations, changes in third-party reimbursement and government mandates which impact pharmaceutical pricing, development and commercialization of our products, relationships with our strategic partners, uncertainty of clinical trials, regulatory approval process, product sales concentration, unpredictability of patent protection, technological changes, the effect of economic conditions and other uncertainties detailed in Bentley's filings with the Securities and Exchange Commission.

Bentley Pharmaceuticals, Inc.

CONTACT: Michael D. Price, Vice President, Chief Financial Officer ofBentley Pharmaceuticals, Inc., +1-603-658-6100; or Investors, DeborahArdern-Jones or Lanie Fladell, +1-212-850-5600, or Media, Sean Leous,+1-212-850-5600, all of Financial Dynamics, all for Bentley Pharmaceuticals,Inc.



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