Bentley Pharmaceuticals Provides Update on Product Approvals; Announces 12 Additional Product Dosage Approvals 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 specialty pharmaceutical and drug delivery company, today announced that it has received twelve marketing approvals in Spain for various dosage forms of 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. (generic version of Celexa(R)), finasteride Finasteride Definition Finasteride is a drug that belongs to the class of androgen inhibitors, which means that it blocks the production of male sex hormones. It is sold in the United States and Canada under the brand names Proscar and Propecia. (generic version of Proscar(R)) and 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 (generic version of Pravachol(R)). John A. Sedor, Bentley's President, commented, "These approvals strengthen our portfolio and underscore our success in advancing our pipeline, both in Spain and in other European countries. These latest approvals follow the 51 we received over the past 12 months, including 30 approvals in Spain and 21 in other EU countries." Bentley has received approval of a 30mg generic version of citalopram in Spain through its wholly-owned subsidiaries, Laboratorios Rimafar and Laboratorios Davur, and a branded-generic version of the 30mg dosage level of citalopram through its subsidiary, Laboratorios Belmac. The branded version is marketed under the Belmac trade name, Somac(R). The Company has previous marketing authorizations for 10mg, 20mg and 40mg branded and generic versions of citalopram. Citalopram belongs to a class of selective serotonin-uptake inhibitors, which are used in the treatment of depression. According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. 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 antidepressants Antidepressants Medications prescribed to relieve major depression. Classes of antidepressants include selective serotonin reuptake inhibitors (fluoxetine/Prozac, sertraline/Zoloft), tricyclics (amitriptyline/ Elavil), MAOIs (phenelzine/Nardil), and heterocyclics in Spain is approximately $540 million, of which citalopram accounts for approximately $48.7 million. According to IMS, the number of prescriptions written for citalopram in the Spanish market has grown at a rate of approximately 8% over the past 12 months. The Company has also received approval to market a 5mg generic version of finasteride in Spain through each of its wholly-owned subsidiaries, Belmac, Davur and Rimafar. Finasteride belongs to a class of Type II 5 alpha-reductase inhibitors used in the treatment of enlarged prostate Enlarged Prostate Definition A non-cancerous condition that affects many men past 50 years of age, enlarged prostate makes urinating more difficult by narrowing the urethra, a tube running from the bladder through the prostate gland. glands. In addition, Bentley's subsidiaries Laboratorios Rimafar and Laboratorios Belmac each received approvals to market generic-equivalent and branded versions of pravastatin in 10mg, 20mg and 40mg tablets. Pravastatin is a cholesterol-reducing agent marketed by Bristol-Myers Squibb under the trade name of Pravachol(R). These approvals follow the acquisition of marketing rights for pravastatin by Bentley's subsidiary Laboratorios Davur. In October 2005, the subsidiary received the right to market 10mg, 20mg, 40mg and 80mg dosage levels of pravastatin in Spain. 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 a growing portfolio of generic and branded pharmaceuticals in Europe for the treatment of cardiovascular, gastrointestinal, infectious and neurological diseases through its subsidiary, Laboratorios Belmac, and markets these pharmaceutical products through its subsidiaries, Laboratorios Belmac, Laboratorios Davur, Laboratorios Rimafar and Bentley Pharmaceuticals Ireland; 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 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: This press release contains forward looking statements, including without limitation, statements regarding the approval of our citalapram, finastride and pravastatin products, the potential markets for these pharmaceutical products and our growth plans and strategy. 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, risks associated with international operations and other uncertainties detailed in Bentley's most recent Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 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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