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Bentley's European Subsidiaries Receive New Marketing Approvals; Laboratorios Davur Acquires Right to Market Pravastatin; Laboratorios Davur and Rimafar Receive Approvals to Market Branded and Generic Versions of Ciprofloxacin.


EXETER, N.H. -- Bentley Pharmaceuticals, Inc. (NYSE NYSE

See: New York Stock Exchange
: BNT BNT Bentley Pharmaceuticals, Inc. (stock symbol)
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), a technology-based specialty pharmaceutical and drug delivery company with a growing branded and generic product line in Europe, today announced that Laboratorios Davur has acquired the rights to market 10mg, 20mg, 40mg and 80mg dosage levels of pravastatin pravastatin /prav·a·stat·in/ (prav´ah-stat?in) an antihyperlipidemic agent that acts by inhibiting cholesterol synthesis, used as the sodium salt in the treatment of hypercholesterolemia and other forms of dyslipidemia and to lower the  in Spain. Additionally, two of its Spanish subsidiaries (Davur and Rimafar) have each received approvals to market 250mg, 500mg and 750mg branded and generic versions of ciprofloxacin ciprofloxacin /cip·ro·flox·a·cin/ (sip?ro-flok´sah-sin) a synthetic antibacterial effective against many gram-positive and gram-negative bacteria; used as the hydrochloride salt.

cip·ro·flox·a·cin
n.
 in Spain.

Pravastatin belongs to a class of cholesterol reducing agents and is marketed under the tradename of Pravachol(R) by Bristol Myers Squibb. According to 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 market size of this class of statin stat·in
n.
Any of a class of drugs that inhibit a key enzyme involved in the synthesis of cholesterol and promote receptor binding of LDL cholesterol, resulting in decreased levels of serum cholesterol.
 products over the trailing twelve months In commerce, the trailing twelve months (TTM) is a moving measurement (for example, an average or a sum) over the 12 previous months, using the most recent data available.

Also sometimes known as last twelve months (LTM).
 in Spain is approximately $580 million, of which pravastatin accounts for approximately $119 million.

Ciprofloxacin belongs to a class of anti-infective products used in the treatment of a wide range of bacterial infections. The product is marketed by Bayer in the United States under the trade name Cipro(R). According to IMS, the market size of this class of fluoroquinolone fluoroquinolone /flu·o·ro·quin·o·lone/ (-kwin´o-lon) any of a subgroup of fluorine-substituted quinolones, having a broader spectrum of activity than nalidixic acid.

fluor·o·quin·o·lone
n.
 anti-infectives over the trailing twelve months in Spain is approximately $77 million, of which ciprofloxacin accounts for approximately $21 million.

James R. Murphy, Bentley's 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. , commented, "The acquisition of pravastatin and the additional approvals of ciprofloxacin are a welcome complement to our existing cardiovascular and anti-infective product lines."

Murphy continued, "We plan to launch our pravastatin products at the end of this year or in early 2006. Our pravastatin product line will be promoted along with our growing simvastatin simvastatin /sim·va·stat·in/ (sim´vah-stat?in) an antihyperlipidemic agent that acts by inhibiting cholesterol synthesis, used in the treatment of hypercholesterolemia and other forms of dyslipidemia and to lower the risks associated  line within in our current portfolio. Ciprofloxacin will be promoted along with our existing anti-infective products. Additional marketing approvals in Spain, the UK and other EU countries for other therapeutic applications are anticipated in the near future, subject to regulatory action."

Bentley Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on advanced drug delivery technologies and pharmaceutical products. Bentley's proprietary drug technologies enhance or facilitate the absorption of pharmaceutical compounds across various membranes. Bentley also manufactures and markets a growing portfolio of generic and branded pharmaceuticals in Europe for the treatment of cardiovascular, gastrointestinal, infectious and neurological diseases through its subsidiaries, Laboratorios Belmac, Laboratorios Davur and Laboratorios Rimafar; and manufactures and markets active pharmaceutical ingredients through its subsidiary, Bentley API.

Copies of Bentley Pharmaceuticals' press releases and other information may be obtained through Bentley's web site at www.bentleypharm.com.

Safe Harbor 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: This press release contains forward looking statements, including without limitation, statements regarding our new pravastatin and ciprofloxacin products and for other new product approvals expected in the UK, Spain and the rest of Europe. 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.
COPYRIGHT 2005 Business Wire
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Publication:Business Wire
Geographic Code:1USA
Date:Oct 20, 2005
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