Bentley Pharmaceuticals Receives Approval to Market Simvastatin in Spain, and has Licensed its Generic Simvastatin for other EU Countries.

Business & Health/Medical Editors

NORTH HAMPTON, N.H.--(BUSINESS WIRE)--Nov. 5, 2001

Cholesterol-lowering Product Launch Planned for First Quarter 2002

Bentley Pharmaceuticals, Inc. (AMEX: BNT), a drug delivery company with a commercial presence in Europe, announced today that its subsidiaries have been granted approval by the Spanish Ministry of Health to market generic equivalents of simvastatin in Spain.

Laboratorios Belmac has received approval from the Ministry of Health to manufacture and market 10 mg., 20 mg., and 40mg. tablet dosage forms and simultaneous authorizations were granted to Laboratorios Davur for the same. Presently, there are no generic versions of simvastatin marketed in Spain. Bentley plans to launch the products through each subsidiary during the first quarter of 2002.

The company also announced that it has licensed these generic equivalents for marketing in other European Union countries and will supply finished product to licensees from its manufacturing facility in Zaragosa, Spain. This drug belongs to a class of lipid-lowering compounds used for controlling cholesterol and is commonly known under the tradename of Zocor(R), which is marketed by Merck & Co (NYSE: MRK).

James R. Murphy, Chairman and CEO, said, "We have been looking forward to approval of these products because they will be among the first launched into the Spanish generic market. We are pleased to be among the first approved to market these products and to be able to fill an important need in the Spanish prescription market. According to the IMS, the annual market for simvastatin in Spain is approximately $77 million and is growing at a rate of 22% annually. These products, as well as other recent and pending approvals are expected to contribute to short-term growth of our Spanish subsidiaries Laboratorios Belmac and Laboratorios Davur."

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 through its subsidiaries Laboratorios Belmac, Laboratorios Davur, and Laboratorios Rimafar.

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 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