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Phase 2 Intranasal Insulin Study Demonstrates Promising Results

EXETER, NH, December 9, 2004 – 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.”

Source: Bentley Pharmaceuticals, Inc.

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