Bentley Pharmaceuticals Receives Approval to Market Generic Versions of Risperidone in Spain.EXETER, N.H. -- Bentley Pharmaceuticals, Inc. (NYSE NYSE See: New York 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 technology-based specialty pharmaceutical and drug delivery company with a growing branded and generic product line in Europe, announced today that one of its Spanish subsidiaries, Laboratorios Davur, has received approval to market 1 mg, 3 mg and 6 mg generic dosage versions of risperidone in Spain. Risperidone belongs to a class of antipsychotic products used in the treatment of schizophrenia The concept of a cure as such in the treatment of schizophrenia remains controversial, as there is no consensus on the definition of "treatment" in the case of schizophrenia, although some criteria for the remission of symptoms have recently been suggested. . The product is marketed by Janssen Pharmaceutica Products, L.P. in the U.S. under the trade name Risperdal(R). 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 antipsychotic pharmaceutical products in Spain is approximately $415 million, of which, risperidone accounts for approximately $100 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, "Generic risperidone provides us with another complement to our growing portfolio of antidepressants, which already includes some of the best selling antidepressants on the market including paroxetine paroxetine /par·ox·e·tine/ (pah-rok´se-ten) a selective serotonin uptake inhibitor used as the hydrochloride salt to treat depression and obsessive-compulsive, panic, and social anxiety disorders. (equivalent to Paxil(R)), fluoxetine fluoxetine /flu·ox·e·tine/ (floo-ok´se-ten) a selective serotonin reuptake inhibitor used as the hydrochloride salt in the treatment of depression, obsessive-compulsive disorder, bulimia nervosa, and premenstrual dysphoric disorder. (equivalent to Prozac(R)), mirtazapine (equivalent to Remeron(R)), citalopram citalopram /ci·tal·o·pram/ (si-tal´o-pram) 1. an antidepressant compound used in the treatment of major depressive disorder, administered orally as the hydrobromide. 2. (equivalent to Celexa(R)) and sertraline sertraline /ser·tra·line/ (ser´trah-len) a selective serotonin reuptake inhibitor used as the hydrochloride salt in the treatment of depression, obsessive-compulsive disorder, and panic disorder. (equivalent to Zoloft(R)). While we anticipate many additional product approvals in Spain, we have a number of regulatory filings pending in the U.K. and other E.U. countries for other therapeutic applications, some of which should be forthcoming over the balance of 2005." 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 prospects for our new risperidone product and for other new product approvals in 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 development and commercialization of our products and their regulatory review, the effects of economic conditions, risks associated with international operations, competition from other manufacturers of generic and proprietary pharmaceuticals, the unpredictability of patent protection, technological changes, 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. |
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