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Bentley Pharmaceuticals Receives Second Approval To Manufacture And Market Generic Omeprazole In Spain; Plans to Launch By the 1st Quarter of 2001.


Business Editors & Health and Medical Writers

NORTH HAMPTON, N.H.--(BUSINESS WIRE)--Nov. 10, 2000

Bentley Pharmaceuticals, Inc. (AMEX AMEX

See: American Stock Exchange
: BNT BNT Bentley Pharmaceuticals, Inc. (stock symbol)
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), a drug delivery company with a commercial presence in Europe, announced today that it has been granted a second approval by the Spanish Ministry of Health to manufacture and market a generic version of omeprazole omeprazole /omep·ra·zole/ (o-mep´ra-zol) an inhibitor of gastric acid secretion used in the treatment of dyspepsia , gastroesophageal reflux disease, disorders of gastric hypersecretion, and peptic ulcer, including that associated with  in Spain.

The company plans to launch the product through its subsidiary, Laboratorios Belmac, by the first quarter of 2001. In July, Bentley announced that its Spanish subsidiary, Laboratorios Davur, had been granted approval by the Spanish Ministry of Health to manufacture and market its generic version of omeprazole in Spain.

Bentley's Omeprazole Belmac 20mg capsule presentation is the generic version of AstraZeneca's, Prilosec(R) and Losec(R) brands, the largest selling drug product worldwide. Prilosec(R) sales in 1999 exceeded $5.9 billion; the drug belongs to a class of antisecretory antisecretory /an·ti·se·cre·to·ry/ (-se-kre´tah-re)
1. secretoinhibitory; inhibiting or diminishing secretion.

2. an agent that so acts, as certain drugs that inhibit or diminish gastric secretions.
 compounds, called "proton pump" inhibitors, used for treating gastrointestinal ulcers as well as disorders associated with gastric acid gastric acid,
n the hydrochloric acid secreted by the gastric glands in the stomach; aids in the preparation of food for digestion.
 secretion, blocking the final step of acid production. The drug, to be manufactured in Bentley's Spanish manufacturing facility in Zaragoza, Spain, will be produced in enteric-coated pellet-form to protect the active ingredient from acidic degradation in the stomach and allow for absorption in the small intestine small intestine

Long, narrow, convoluted tube in which most digestion takes place. It extends 22–25 ft (6.7–7.6 m), from the stomach to the large intestine.
.

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 are pleased to have a second generic equivalent of omeprazole to complement our branded Omeprazole product, Belmazol, to market in Spain. The Spanish market for the therapeutic group of drugs treating ulcers is approximately $369 million and is growing at an annual rate of eight percent whereas the market for controlling acid secretion is approximately $245 million and is growing at an annual rate of approximately 20 percent."

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
COPYRIGHT 2000 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2000, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Nov 10, 2000
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