Bentley Announces Approval of Its First Generic Oncology Product in Spain

Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company, today announced that its subsidiaries, Laboratorios Belmac and Laboratorios Davur, have received product approvals of bicalutamide from the Spanish Ministry of Health. Bicalutamide is the generic equivalent to AstraZeneca Pharmaceuticals’ Casodex®. Bicalutamide is prescribed as a treatment to prevent the growth of prostate cancer by blocking the effects of androgens on the cancer cells. The treatment is a non-steroidal, anti-androgenic product orally administered as a 50 mg. tablet. "This is our first generic product in the oncology area,” said John Sedor, president Bentley Pharmaceuticals, Inc. "We are pleased to continue to leverage our generic expertise, including proven formulation capabilities in solid oral dosage, to serve this important, growing market.” The next steps towards market launch of bicalutamide for Bentley are to apply for product pricing and building inventory. According to IMS Health Inc., the annual market size for bicalutamide in Spain is approximately $65 million (USD) and has grown 12% over the trailing twelve months. To date, this branded product has been very expensive for the healthcare system. 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 bicalutamide product approval in Spain and its market prospects. 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.