Bentley Pharmaceuticals Reports Successful Results of Its First Phase II Intranasal Insulin Study in Diabetic Patients.

EXETER, N.H. -- Bentley Pharmaceuticals, Inc. (NYSE: BNT), a technology-based specialty pharmaceutical and drug delivery company with a growing branded and generic product line in Europe, announced today that it has successfully delivered insulin in Type I diabetic patients utilizing its CPE-215 nasal spray formulation in its first Phase II study. This study is the second intranasal insulin study conducted by a clinical research organization in a hospital-based clinical pharmacology unit in Ireland in compliance with U.S. and European clinical standards.

This study was the first study conducted in a target population of diabetic patients and was exploratory in nature to determine absorption of insulin and timing of dosing. Seven diabetic patients received up to four doses of intranasal insulin spray, subcutaneous insulin or placebo. The total dose of intranasal insulin spray ranged from 25 to 100 International Units. Preliminary results indicate that the intranasal insulin was well absorbed and that there was partial suppression of the postprandial glucose elevation in the two hours after a standard breakfast, similar to that seen with subcutaneous insulin.

James R. Murphy, Bentley's Chairman and CEO, commented, "These preliminary results are very encouraging. After full analysis of all data, we plan to design further studies in patients to better define the entire profile of our formulation. In addition, we are currently preparing to seek a development partner as we progress further into Phase II and then Phase III development. Scientists have known for years that the intranasal route of administration of therapeutic agents was a highly efficient route, but success in this route of administration has been difficult due to low delivery payload, poor reproducibility and/or mucosal irritation. We are particularly encouraged by these results because they reinforce the potential for the intranasal delivery of other peptides as well."

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; and manufactures and markets active pharmaceutical ingredients through its subsidiary, Bentley API.

Copies of Bentley Pharmaceuticals' press releases and other information 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 intranasal delivery of insulin using Bentley's proprietary technologies and Bentley's plan to seek a partner for the future clinical development of its intranasal insulin formulations. 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 timing and results of clinical trials, efficacy and safety of our products, the timing and nature of regulatory approvals, changes in third-party reimbursement and government mandates which impact pharmaceutical pricing, development and commercialization of our products, competition from other manufacturers of proprietary pharmaceuticals, intellectual property litigation, our relationships with our strategic partners, the unpredictability of patent protection, technological changes, the effects of economic conditions and other uncertainties detailed in Bentley's most recent Annual Report on Form 10-K and its other 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.