Healthcare Industry News:  osteoporosis 

Biopharmaceuticals Generics Regulatory

 News Release - November 1, 2007

Bentley Announces Its First Product Approval in France

Company Receives Approval For Generic Version of Prevacid(R) in France and Generic Version of Fosamax(R) in Ireland

EXETER, N.H.--(HSMN NewsFeed)--Bentley Pharmaceuticals, Inc. (NYSE: BNT ), a specialty pharmaceutical company focused on advanced drug delivery technologies and generic pharmaceutical products, today announced its European subsidiaries have received their first product approval in France, which is for Lansoprazole, a generic version of Prevacid®.

Lansoprazole is used to treat gastrointestinal diseases including acid reflux and ulcers and is marketed under the trade name, Prevacid®, in the US by TAP and in Europe by Takeda Pharmaceuticals. Lansoprazole is under patent protection in France until December 11, 2007. Bentley subsidiaries plan to be in the French market, through partners and licensees, at the time of market formation upon patent expiration. Firm orders have been received under long-term supply agreements and the finished products will be supplied in the fourth quarter from Bentley’s subsidiary manufacturing facilities in Spain. According to the IMS, the market size for Lansoprazole in France is approximately $220 million.

Bentley’s Irish subsidiary also received approvals for marketing a generic version of a once weekly dosage form of alendronate in Ireland. Alendronate is used in the treatment of osteoporosis and bone loss, and is the generic version of Fosamax®, which is currently marketed by Merck & Company, Inc.

John Sedor, president of Bentley Pharmaceuticals, said, “These recent approvals not only open additional major markets for the continued growth of our European business outside of Spain, but also enhance the value of our European operations. We expect to be filling orders for these products in France and Ireland in the fourth quarter. We are also expecting similar approvals in other major European markets in the near future.”

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 website 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 France and Ireland, the potential impact of these approvals on Bentley’s results of operations and Bentley’s opportunities in the European generics market. 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.



Source: Bentley Pharmaceuticals

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