Bentley Granted European Patent for Its Testosterone Gel

Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company, announced today that the European Patent Office has issued patent number 1425019 entitled "Pharmaceutical Composition.” This patent provides coverage for the pharmaceutical composition process and method of use of testosterone as a gel as well as other androgens, incorporating Bentley’s CPE-215® drug delivery technology. Issued from an application submitted on April 21, 2003, the new European patent provides proprietary protection to Bentley for 20 years from the date of filing. Bentley’s licensee – Auxilium Pharmaceuticals, Inc. (NASDQ: AUXL) – successfully launched this testosterone gel in the United States in early 2003 under the brand name Testim®, and the product now commands nearly 20 percent of the U.S. market for topical testosterone replacement therapy. Testim has been approved for marketing in Canada and 15 EU countries including Belgium, Germany, Greece, Ireland, Portugal, Spain, Sweden and the United Kingdom, and has received scientific approval in Italy. "This European patent significantly strengthens and extends the intellectual property franchise protecting Bentley’s drug delivery technology,” said John Sedor, president of Bentley Pharmaceuticals, Inc. "We anticipate further strengthening of this IP portfolio beyond Europe in the year ahead.” The testosterone replacement market has increased as more baby-boomers enter middle age and more attention is focused on male hormonal deficiencies. The U.S. Food and Drug Administration estimates that about 4-5 million Americans suffer from male hypogonadism – a condition where insufficient amounts of testosterone are produced – and that male hypogonadism affects about 5 in every 1,000 men. It is believed that male hypogonadism affects one out of every 5 men over age 50. Symptoms associated with low testosterone levels in men include depression, decreased libido, erectile dysfunction, muscular atrophy, loss of energy, mood alterations, increased body fat and reduced bone density. The condition is significantly under-treated. Growing patient awareness and education continue to spur demand for testosterone replacement therapy. Currently marketed hormone replacement therapies deliver hormones through injections, transdermal patches and gels. Injection therapy has limitations, including pain, which can lead to decreased patient acceptance and decreased compliance. Although patches have alleviated many of the side effects associated with other methods of delivery of hormones, patches are often conspicuous and may result in skin irritation or even inaccurate dosing should the patch fall off. The transdermal delivery of hormones through gels, creams and lotions provides commercially attractive and efficacious alternatives. Testim delivers 30 percent more testosterone transdermally than its leading competitor. About Bentley’s Permeation Enhancement Technology Bentley’s CPE-215 drug delivery technology has the potential to enhance the absorption of drugs across a variety of biological membranes, including not only the skin, but also the nasal mucosa. The Company is developing an intranasal drug delivery technology based on CPE-215. This technology has the potential to improve drug delivery of more complex molecules, especially injectable therapeutic peptides for treatment of chronic diseases. Bentley’s first patented product candidate for intranasal drug delivery is Nasulin™, an insulin formulation currently in global Phase II clinical trials for the treatment for diabetes. Bentley is continuing to expand its drug delivery technology intellectual property portfolio and was awarded a broad patent on July 19, 2007, for delivery of other peptides, peptidomimetics and proteins via Bentley’s drug delivery technology utilizing CPE-215®. About Bentley Pharmaceuticals Bentley Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on advanced drug delivery technologies and generic pharmaceutical products. Bentley’s proprietary drug delivery technologies enhance the absorption of pharmaceutical compounds across various membranes. Bentley manufactures and markets a growing portfolio of generic and branded generic pharmaceuticals in Europe for the treatment of cardiovascular, gastrointestinal, infectious and central nervous system diseases through its subsidiaries -- Laboratorios Belmac, Laboratorios Davur, Laboratorios Rimafar and Bentley Pharmaceuticals Ireland. Bentley also manufactures and markets active pharmaceutical ingredients through its subsidiary, Bentley API. Additional information regarding Bentley Pharmaceuticals may be obtained through Bentley’s web site at 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 patent coverage for Bentley’s CPE-215 drug delivery technology and the therapeutic and commercial potential of that technology. 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 efficacy and safety of Bentley’s drug delivery technology, competition from other manufacturers of new products, the unpredictability of patent protection, intellectual property litigation, and other risks detailed under Item 1A "Risk Factors” in Bentley's most recent Annual Report on Form 10-K and its 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.