Monday, June 13, 2005

Bentley Pharmaceuticals, Inc. Presents Results of Initial Phase II Intranasal Insulin

Study at the June 2005 ADA Meeting; Study Shows More Rapid Absorption and Higher Peak Levels Than Subcutaneous Insulin EXETER, N.H.--(BUSINESS WIRE)--June 13, 2005--Bentley Pharmaceuticals, Inc. (NYSE: BNT), a technology-based specialty pharmaceutical and drug delivery company with a growing branded and generic product line in Europe, today announced that it presented the results of its initial Phase II study in Type I diabetic patients entitled "Intranasal Insulin Administration in Type I Diabetic Patients Utilizing CPE-215 Technology" at a poster session of the American Diabetic Association meeting on June 11, 2005 in San Diego, California. Seven patients were studied at the Shandon Clinic and the Department of Clinical Pharmacology at the University of Cork, in Cork, Ireland.
Bentley's intranasal formulation demonstrated more rapid absorption and higher peak levels than subcutaneous insulin. It blunted post-prandial hyperglycemia for over two hours. Calculated relative bioavailability (amount of total dose absorbed) as compared to subcutaneous insulin was 15-20%, which is greater than that of most reported studies of inhaled insulin formulations. Further development work is planned.
Jim Murphy, President and CEO commented, "While we are still in the initial phases of our intranasal insulin studies, we believe that the demonstrated characteristics of rapid onset of action and greater than two hour suppression of post-prandial hyperglycemia are indications that our formulation may be useful in the treatment of diabetes. We believe that many diabetic patients would prefer an intranasal application of insulin, specifically those patients who are averse to multiple daily injections, and this would lead to increased compliance with treatment regimens."
Bentley Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on advanced drug delivery technologies and pharmaceutical products. Bentley's proprietary drug technologies are designed to 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 therapeutic potential of Bentley's intranasal insulin formulation. 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 in development, competition from other manufacturers of generic and proprietary pharmaceuticals, technological changes, 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.
Contacts
Bentley Pharmaceuticals, Inc. Michael D. Price, 603-658-6100www.bentleypharm.com or Porter, Le Vay & Rose, Inc.Investor Relations Contacts: Linda Decker, V.P. - Investor Relations Jeff Myhre, V.P. - Editorial 212-564-4700or Tom Gibson - Media Relations