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| |  Testim Testosterone Gel Enhances Sexual Motivation and Performance In Males With Hypogonadism EXETER, NH -- June 10, 2003 -- Bentley Pharmaceuticals, Inc. (Amex: BNT), a technology-based specialty pharmaceutical and drug delivery company with a growing branded and generic product line in Europe, reported that the results of the largest placebo- controlled study ever conducted to measure the benefits of testosterone replacement therapy show that men treated with Testim™ testosterone gel have significant improvements in measurable areas related to sexual performance, including spontaneous erections and levels of sexual motivation and desire. Testim uses Bentley's proprietary drug delivery technology. The study results, published in the June 2003 issue of The Journal of Clinical Endocrinology & Metabolism, further showed that treatment for hypogonadism (low testosterone) using Testim testosterone gel significantly improved sexual performance while also increasing lean body mass without exercise. This was the first large-scale study ever conducted comparing the results of testosterone replacement therapy to a placebo. The study was conducted by and Testim was developed and is marketed by Auxilium Pharmaceuticals, Inc., a licensee of Bentley's drug delivery technology for application to certain products. 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. Testosterone levels were measured in blood samples taken over a 24-hour period, and the effect of normalizing serum testosterone levels on body composition, sexual function, mood and bone mineral density were also assessed. Testosterone levels were normalized in significantly more patients treated with Testim gel: 80% of patients treated with 100mg Testim, and 75% of patients treated with 50mg Testim, had corrected their hypogonadal state at the end of the study, versus only 57% of patients treated with the transdermal patch and 10% of placebo-treated patients. Patients treated with Testim also showed greater improvements in lean body mass, spontaneous erections, sexual desire and sexual performance as compared to patients treated with a transdermal patch or placebo. Testim gel was well tolerated, with very low incidence of skin irritation, while patients treated with the transdermal patch reported a high incidence of application site reactions. In addition, prostate adverse events with Testim were very low, and similar to placebo. 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 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 is being marketed in the U.S. by Auxilium Pharmaceuticals, Inc. and its professional sales force. It is likely to be marketed in Europe and other parts of the world through partnering or licensing agreements.
SOURCE: Bentley Pharmaceuticals, Inc.
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