Bentley Pharmaceuticals Announces Product Approvals In Europe

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 18 Feb 2008 - 1:00 PDT

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Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company, announced that its European subsidiaries have received approvals to market their omeprazole capsule products, through their licensees, in various territories in Europe.

The approvals are for 10 mg. 20 mg. and 40 mg. dosage levels of omeprazole capsules under a Mutual Recognition Procedure (MRP) that grants simultaneous authorizations throughout the EU. Bentley's subsidiaries expect to supply omeprazole to their licensees in the major markets of Germany and Italy, as well as other EU countries. Omeprazole is marketed in the United States under the trade name Prilosec® by AstraZeneca and under the trade name Losec® in Europe.

The manufacture and supply of the finished products will be through Bentley's subsidiary, Laboratorios Belmac. The Company plans to begin supplying omeprazole to licensees during the first quarter of 2008.

Jim Murphy, Chairman & Chief Executive Officer of Bentley Pharmaceuticals said, "Representing our first product entry into the major European markets of Germany and Italy, these approvals follow the November 2007 announcement of our entrance into France by way of similar agreements to distribute lansoprazole. We expect that these MRP approvals, together with other MRP registrations pending, will grow our specialty generic revenues outside of Spain by approximately 25% in 2008."

Murphy continued, "We have made the expansion of our products into major European markets beyond Spain a primary objective over the past few years, and receiving these multiple approvals is a milestone in that initiative. We look forward to further enhancing the value of our European operations by capitalizing on additional opportunities in these larger EU markets."

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 plans to spin off its drug delivery business as an independent, publicly traded company. Its newly formed subsidiary, CPEX Pharmaceuticals, Inc., has filed an initial registration statement on Form 10 with the Securities and Exchange Commission (SEC) in furtherance of this plan. Completion of the proposed spin-off is subject to numerous conditions, including final approval by Bentley's Board of Directors and the effectiveness of the registration statement on Form 10, which is subject to review by the SEC. Bentley's generic pharmaceuticals business manufactures and markets a growing portfolio of generic and branded generic products 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 http://www.bentleypharm.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995

This press release contains certain forward-looking statements about Bentley Pharmaceuticals, Inc. and its current and future business, which are based on management's good faith expectations and beliefs concerning the prospects for Bentley to expand its generic pharmaceutical business in European markets outside of Spain, and future developments in Bentley and CPEX Pharmaceuticals. Forward-looking statements can be identified by the use of words such as "in the future," "will," "may," "believe," "expect," "plans," "strategy," "intends," and "estimate." Statements that refer to the future prospects of Bentley or CPEX Pharmaceuticals are forward-looking statements that reflect Bentley's current analysis of existing trends, information and current plans.

Actual results may differ from current expectations based on a number of factors affecting Bentley's businesses, including changing competitive, regulatory and market conditions; approval, introduction and consumer acceptance of new products and continuing acceptance of currently marketed products; unpredictability associated with the timing and the results of both the research and development and regulatory processes; inherent uncertainty associated with financial projections, which cannot be predicted with certainty; technological advances and patents obtained by competitors; uncertainty associated with the identification of and successful execution of external corporate development transactions and strategic alliance partners; matters affecting the economy in general, such as changes in interest and currency exchange rates; the uncertainties associated with effecting a spin-off of a separate public company; the discretion of Bentley's Board of Directors to delay or cancel the spin-off prior to execution; 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, as well as the risks set forth in the "Risk Factors" section of the Bentley Form 10-K. Bentley disclaims any intent or obligation to update these forward-looking statements.

Bentley Pharmaceuticals