Bentley Announces Approval for Tamulosin in Spain

Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company, today announced that its subsidiaries, Laboratorios Davur and Laboratorios Rimafar, have received product approval for tamulosin from the Spanish Ministry of Health. Bentley’s subsidiary, Laboratorios Belmac, also received approval for a branded generic equivalent of tamulosin under the trade name Vetevel™. Tamulosin is the generic equivalent to Boehringer Ingelheim’s product marketed under the trade name Urolosin® in Spain and Flomax® in the U.S. Tamulosin is used in the treatment of benign prostatic hyperplasia, commonly referred to as BPH, and related bladder outlet obstruction. According to IMS Health Inc., the annual market size in Spain for tamulosin is approximately $93 million (USD) and grew by 6.4% over the trailing twelve months. "With this approval, we continue to expand and diversify our suite of generic product offerings in Spain, currently the seventh largest pharmaceutical market in the world,” said John Sedor, president Bentley Pharmaceuticals, Inc. "The Spanish market is increasingly seeking the more affordable pricing that generics can offer and we look forward to meeting this need.” 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 tamulosin product approval in Spain and market prospects for this product. 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.