{1} Announces Results Of A Successful Phase I Study Of Intranasal Insulin In Human Volunteers

EXETER, N.H., Feb. 2 /PRNewswire-FirstCall/ -- Bentley Pharmaceuticals, Inc. , a specialty pharmaceutical company focused on advanced drug- delivery technologies, which also manufactures and markets generic and branded products in Europe, announced today that it has successfully completed a Phase I clinical trial using its proprietary intranasal insulin formulation in human volunteers. The study was conducted by a clinical research organization in a hospital based clinical pharmacology unit in Ireland in compliance with U.S. and European clinical standards, and provided encouraging results. The clinical study consisted of 8 healthy (non-diabetic) human volunteers who, over several weeks, each received up to four intranasal sprays of insulin utilizing Bentley's proprietary drug delivery technology.

James R. Murphy, Bentley's Chairman and CEO, commented, "We are excited by such positive results in this early stage of our developmental program. The study demonstrated a consistent response in the group. Elevated blood insulin levels were detected within 10 minutes of nasal administration, a peak increase at about 20 minutes and return to pre-dose levels by 60-90 minutes. Baseline blood glucose levels were quickly depressed in a dose-related manner, with a peak decrease at about 40 minutes after nasal insulin administration. These results are also consistent with a decrease in the normal volunteers' baseline blood insulin levels, as measured by plasma C-peptide, which occurred at about 60 minutes after nasal insulin dosing."

Murphy continued, "We are proceeding with the design of a protocol for evaluation in diabetic patients. Our formulation is designed to blunt the increase in glucose following meals which may greatly reduce the number of insulin injections required to be taken by Type I diabetics (those requiring insulin); and it may reduce the number of medications currently required to be taken by Type II diabetics (those not requiring insulin). Work will continue on formulation development and the selection of an appropriate administration device for variable dosing. Additional development funds have been allocated to this project."

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. Copies of Bentley Pharmaceuticals' press releases and other information may be obtained through Bentley's web site at http://www.bentleypharm.com/.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: The statements which are not historical facts contained in this press release are forward-looking statements that involve certain risks and uncertainties including but not limited to risks associated with identifying suitable drugs for drug delivery technologies, expanding generic and branded drug operations, changes in third-party reimbursement and government mandates which impact pharmaceutical pricing, development and commercialization of our products, relationships with our strategic partners, uncertainty of clinical trials, regulatory approval process, product sales concentration, unpredictability of patent protection, technological changes, the effect of economic conditions and other uncertainties detailed in Bentley's filings with the Securities and Exchange Commission.

Bentley Pharmaceuticals, Inc.