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Bentley Receives Broad U.S. Patent Protection for Its Intranasal Drug Delivery Technology


Thursday, July 19, 2007

Patent Extends Protection of Bentley’s Platform Beyond Insulin to Include All Therapeutically Effective Peptides, Peptidomimetics and Proteins

Exeter, NH -- Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company, announced today that the U.S. Patent and Trademark Office has issued patent number 7,244,703 entitled "Pharmaceutical Compositions and Methods for Peptide Treatment." This patent extends coverage for Bentley’s current intranasal drug delivery technology utilizing CPE-215® beyond insulin to include delivery of other therapeutically effective, pharmaceutically active peptides, peptidomimetics and proteins. Many such molecules are already in commercial use in chronic clinical indications employing injections that could benefit patients through enabling of nasal administration formats. In September 2006, Bentley received a U.S. patent covering Bentley’s intranasal delivery spray for insulin.

"This patent is a critical milestone for Bentley as it provides us with broad protection for our intranasal drug delivery technology and for future applications," said John Sedor, president of Bentley Pharmaceuticals, Inc. "These applications have the potential to be far-reaching. We believe our CPE-215 intranasal delivery technology can provide therapeutic and commercial advantages for the delivery of a number of complex molecules that address a wide variety of metabolic, neurological and other serious medical conditions. In particular, intranasal drug delivery has the potential to be beneficial to patients, including children and the elderly, who are resistant to treatments with injectable pharmaceuticals. Our intranasal drug delivery technology also has the potential to create significant opportunities for life-cycle extension of existing marketed products."

This new patent, which was issued from an application filed on March 5, 2004, provides proprietary protection to Bentley for 20 years from the date of filing.

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 the skin, mouth, nose and eye. The effectiveness of Bentley’s patented permeation technology was validated in the product Testim®, a testosterone replacement gel licensed to Auxilium Pharmaceuticals (Nasdaq: AUXL). Since its launch in 2003, Testim has gained a leadership position in the testosterone gel market.

Bentley determined that its intranasal technology could be extended to improve drug delivery of more complex molecules, especially injectable therapeutic peptides for treatment of chronic diseases. Bentley’s development work led it to incorporate its drug delivery technology, employing the key excipient CPE-215, into Nasulin™, Bentley’s patented product candidate for the intranasal administration of insulin. In addition to studies reported previously, positive initial clinical results for Nasulin in three other Company-sponsored studies were presented at the American Diabetes Association’s 67th Scientific Sessions in late June 2007. Nasulin is currently in global Phase II clinical trials.

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 the potential for development of pharmaceutical product candidates employing active peptides, peptidomimetics and proteins using intranasal delivery methods covered by Bentley’s intranasal technology patent, the potential advantages of such products and the potential of Bentley’s Nasulin product candidate. 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 unpredictability of patent protection and technological changes, risks associated with further studies of the safety and efficacy of Bentley’s intranasal insulin product candidate and its drug delivery technology, risks inherent in the conduct of international clinical trials and regulatory review of a pharmaceutical product, 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.



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