Bentley Announces Product Approvals for Generic Pharmaceuticals

Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company, today announced the receipt of two product approvals in Europe. The Company’s subsidiaries in Spain, Laboratorios Belmac, Laboratorios Davur and Laboratorios Rimafar, received product approval for venlafaxine extended release from the Spanish Ministry of Health. The Company’s subsidiary in Ireland, Bentley Pharmaceuticals Ireland Limited, has received approval for alendronate from the Irish Medicines Board. Venlafaxine is the generic equivalent to the Wyeth Pharmaceuticals, Inc. product marketed in the U.S. under the trade name Effexor®, which is used in the treatment of depression. According to IMS Health, Inc., the annual market size in Spain for venlafaxine is approximately $118 million (USD) and grew by 6% over the trailing twelve months. Alendronate, often used in the treatment of bone loss, is the generic version of the product currently marketed by Merck & Co., Inc. under the trade name Fosamax®. IMS Health, Inc. estimates the annual market for alendronate in Ireland is approximately $17 million (USD). "Receiving these product approvals is another step forward in our strategy to strengthen our generics business in Spain while at the same time capitalizing on growth in demand for generic pharmaceuticals elsewhere in Europe,” said John Sedor, president of Bentley Pharmaceuticals, Inc. "In Ireland and Spain, as in the rest of Europe and markets around the world, the costs associated with an aging population consuming an expanding range of pharmaceuticals are straining the healthcare system. Generics are becoming an increasingly attractive and acceptable way to contain these costs – especially given the large number of branded pharmaceuticals that have recently or soon will be going off patent. Our broad portfolio of commercialized generic pharmaceuticals and our pipeline of pending approvals position us to continue building Bentley’s presence in the European generics market.” Bentley Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on advanced drug delivery technologies and generic pharmaceutical products. Bentley’s proprietary drug delivery technologies enhance the absorption of pharmaceutical compounds across various membranes. Bentley manufactures and markets a growing portfolio of generic and branded generic pharmaceuticals in Europe for the treatment of cardiovascular, gastrointestinal, infectious and central nervous system diseases through its subsidiaries -- Laboratorios Belmac, Laboratorios Davur, Laboratorios Rimafar and Bentley Pharmaceuticals Ireland. Bentley also manufactures and markets active pharmaceutical ingredients through its subsidiary, Bentley API. Additional information regarding Bentley Pharmaceuticals 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 Bentley’s new product approvals in Spain and Ireland, and Bentley’s prospects in Spain and Ireland. 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 nature of regulatory approvals, changes in third party reimbursement and government mandates which impact pharmaceutical pricing, competition from other manufacturers of generic and proprietary pharmaceuticals, 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.