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Auxilium Pharmaceuticals, Inc. and Bentley Pharmaceuticals, Inc. Announce Issuance of Patent Covering Testim(R)

Market Wire, January, 2008

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) and Bentley Pharmaceuticals, Inc. (NYSE: BNT) today announced that the United States Patent and Trademark Office ("USPTO") has issued U.S. Patent No. 7,320,968 covering TestimĀ®, 1% testosterone gel, marketed by Auxilium under license from Bentley. The patent will expire in January 2025. Auxilium plans to list the patent promptly in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration. The companies also announced that Bentley has filed a divisional application and continuations with the USPTO, which, if granted, may expand the scope of patent claims covering Testim.

"We are very pleased that Testim now has patent protection through January 2025," said Mr. Armando Anido, Chief Executive Officer and President of Auxilium Pharmaceuticals. "Testim is a great product that continues to take market share and grow at a high rate, so extending our patent protection through January 2025 is an important accomplishment."

"Receiving extended U.S. patent protection for Testim is an exciting milestone for Bentley and our newly formed CPEX Pharmaceuticals drug delivery subsidiary," said Mr. James R. Murphy, Chairman and CEO of Bentley Pharmaceuticals. "As announced last month, we plan to spin off our drug delivery business as an independent, publicly traded company, CPEX Pharmaceuticals, subject to Board and SEC approval of our recently filed Form 10. The royalties on the rising sales of Testim, both in the United States and in Europe, will contribute to the growth of this business in the years ahead."

About Testim

Testim is a proprietary, clear, topical gel containing 1% testosterone, the same type of hormone that is produced by the human body. When applied once-daily to the upper arms and shoulders, clinical studies have shown that Testim will restore and maintain testosterone levels. Once Testim is absorbed through the skin, it enters the bloodstream and helps return testosterone to normal levels. The efficacy of Testim has been demonstrated in 16 clinical studies involving approximately 1,800 patients, including the largest placebo-controlled study ever conducted to evaluate the benefits and risks of testosterone replacement therapy. For information regarding the safety and use of Testim, please see the prescribing information at http://www.testim.com .

About Auxilium

Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing to urologists, endocrinologists, orthopedists and select primary care physicians. Auxilium markets TestimĀ® 1%, a topical testosterone gel, for the treatment of hypogonadism through its approximately 190-person sales and marketing team. Auxilium has four projects in clinical development. XIAFLEX(TM) (clostridial collagenase for injection), formerly referred to as AA4500, is in phase III of development for the treatment of Dupuytren's contracture and is in phase II of development for the treatment of Peyronie's disease and Frozen Shoulder syndrome (Adhesive Capsulitis). Auxilium's transmucosal film product candidate for the treatment of overactive bladder (AA4010) is in phase I of development. The Company is currently seeking a partner to further develop this product candidate. Auxilium has two pain products using its transmucosal film delivery system in pre-clinical development. Auxilium has rights to six additional pain products and products for hormone replacement and urologic disease using its transmucosal film delivery system. Auxilium also has options to all indications using XIAFLEX for non-topical formulations. For additional information, visit http://www.auxilium.com .

About Bentley and CPEX 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 plans to spin off its drug delivery business as an independent, publicly traded company. Its newly formed subsidiary, CPEX Pharmaceuticals, Inc., has filed an initial registration statement on Form 10 with the Securities and Exchange Commission (SEC) in furtherance of this plan. Completion of the proposed spin-off is subject to numerous conditions, including final approval by Bentley's Board of Directors and the effectiveness of the registration statement on Form 10, which is subject to review by the SEC. Bentley's generic pharmaceuticals business manufactures and markets a growing portfolio of generic and branded generic products 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 website at www.bentleypharm.com .

 

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