Bentley Pharmaceuticals Receives Approval to Manufacture and Market Generic Enalapril in Spain; Plans to Launch in the 4th Quarter.Business Editors & Health/Medical Writers NORTH HAMPTON, N.H.--(BUSINESS WIRE)--Aug. 15, 2000 Bentley Pharmaceuticals, Inc. (AMEX AMEX See: American Stock Exchange :BNT BNT Bentley Pharmaceuticals, Inc. (stock symbol) BNT Boston Naming Test (psychology) BNT Bermuda National Trust BNT Bulgarian National TV BNT Broadband Network Termination BNT Binary File Transfer ), a drug delivery company with a commercial presence in Europe, announced today that it has been granted approval by the Spanish Ministry of Health to manufacture and market generic versions of enalapril in Spain. Laboratorios Belmac has received authorization for 5 mg. and 20 mg. dosage forms and simultaneous authorizations were granted to Laboratorios Davur for the 5 mg and 20 mg tablets. Bentley plans to launch the products through each subsidiary, during the 4th quarter of 2000. These generic presentations of enalapril are the generic equivalent to Merck & Co.'s branded anti-hypertensive product Vasotec(R), and Laboratorios Belmac's product Controlvas(R); Controlvas'(R) sales in 1999 exceeded $2.5 million. The drug belongs to a class of ACE inhibitor ACE inhibitor (ā'sē'ē`, ās) or angiotensin-converting enzyme inhibitor (ăn'jēōtĕn`sĭn) compounds used for treating cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease and hypertension. Laboratorios Belmac, a subsidiary of Bentley, will manufacture the products at its production facility in Zaragoza, Spain. James R. Murphy, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , said, "We have been looking forward to approval of these generic equivalents of enalapril since they will contribute to Laboratorios Belmac's growth following the September launch of sales by our new subsidiary, Laboratorios Davur. According to the IMS (1) See IP Multimedia Subsystem. (2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. , the Spanish market for this therapeutic class of drugs is approximately $180 million, of which enalapril products have captured approximately 50% of this market. Generic versions of enalapril have grown at a rate of 50% over the trailing 12 months. The generic market in Spain is a rapidly growing market and we plan to be a leader in this arena. We currently have more than 20 generic product registrations pending and, as a result of the recent collaboration with Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in , Ltd., (announced July 24), we expect to file many more." Bentley Pharmaceuticals, Inc. is a drug delivery company focused upon improving the absorption of a wide range of drugs and peptides through proprietary drug delivery technologies which it intends to commercialize in the U.S. and other major markets by licensing to other pharmaceutical companies. Bentley also manufactures and commercializes branded and generic products in Europe for the treatment of cardiovascular, gastrointestinal, neurological and infectious diseases through its subsidiaries Laboratorios Belmac and Laboratorios Davur. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995: The statements which are not historical facts contained in this press release are forward-looking statements that involve certain risks and uncertainties including but not limited to risks associated with the uncertainty of future financial results, additional financing requirements, the ability to find effective market distribution channels, development of new products, regulatory approval processes, the impact of competitive products or pricing, unpredictability of patent protection, technological changes, the effect of economic conditions and other uncertainties detailed in the Company's filings with the Securities and Exchange Commission. Copies of the Company's press releases and other information may be obtained through Bentley's web site at www.bentleypharm.com. |
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