Bentley Pharmaceuticals is Cleared to Initiate Studies for Evaluation of a New Topical Product for Treating Nail Fungal Infections.

Business Editors

NORTH HAMPTON, N.H.--(BUSINESS WIRE)--June 1, 2000

Bentley Pharmaceuticals, Inc. (AMEX: BNT), announced today that its IND (Investigational New Drug Application) filed earlier this year, for testing a topical nail lacquer for treating nail-bed fungal infections (onychomycosis) has cleared the FDA 30-day review period.

Bentley has contracted a clinical study to be conducted at the University of Alabama at Birmingham under the direction of Boni Elewski, M.D., one of the world's leading experts in onychomycosis research. The initial study will involve treating approximately 25 patients with fingernail fungal infections for a period of 12 weeks followed by an additional 12-week evaluation period.

James R. Murphy, Chairman and CEO, said, "This is our first regulatory filing and clinical evaluation based upon our CPE-215TM permeation enhancement technologies for improving the absorption of a wide range of therapeutic agents. We have filed a trademark application for the mark, OnycofitexTM, a name similar to a product manufactured and marketed for years by our European subsidiary. Our goal is to develop a new, highly effective, topical nail treatment that is an improvement over the oral therapies, where there have been reports of toxicity and drug interactions, and other topical treatments have low levels of efficacy. We are very excited by this advancement and look forward to completion of this initial phase of evaluation."

Murphy continued, "Our CPE-215TM technology has significant advantages over other delivery systems that are too aggressive, have limited applications, unpleasant chemical odors, and are often irritating to skin, mucosal and ocular membranes. We believe that CPE-215TM overcomes these obstacles and this product has been formulated using a well-established anti-fungal agent that, in addition to a long history of safety and efficacy, displays a broad spectrum of activity against various fungi, molds, and yeasts, known to be the pathogens that cause nail-bed infections. The incidence of nail-bed infections is very high, affecting millions of people who now pay in excess of $1,000 for the regimen of oral treatment. There is a need for an improved, safe product that can treat the disease locally, at the site of the infection, rather than systemically loading patients with medications that can cause adverse side effects. We will continue our discussions with a number of pharmaceutical companies who have expressed interest in licensing this product."

Bentley Pharmaceuticals, Inc. is a drug delivery company focused upon improving the absorption of a wide range of drugs and peptides through proprietary drug delivery technologies which it intends to commercialize in the U.S. and other major markets by licensing to other pharmaceutical companies. Bentley also manufactures and commercializes branded and generic products in Europe for the treatment of cardiovascular, gastrointestinal, neurological and infectious diseases.

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 the uncertainty of future financial results, additional financing requirements, the ability to find effective market distribution channels, development of new products, regulatory approval processes, the impact of competitive products or pricing, unpredictability of patent protection, technological changes, the effect of economic conditions and other uncertainties detailed in the Company's annual report on Form 10-K and its other filings with the Securities and Exchange Commission.

Copies of the Company's press releases and other information may be obtained through Bentley's web site at www.bentleypharm.com.