EXETER, N.H., April 13 /PRNewswire-FirstCall/ -- Bentley Pharmaceuticals, Inc. , a specialty pharmaceutical company focused on advanced drug- delivery technologies, which also manufactures and markets generic and branded products in Europe, announced today that its subsidiaries have been granted approval by the Spanish Ministry of Health to market generic equivalents of sertraline in Spain.
Laboratorios Belmac and Laboratorios Davur, have each received approval from the Ministry of Health to market 50-mg and 100-mg tablet dosage forms of the product in Spain.
Sertraline belongs to a class of anti-depressant products used for treatment of various depressive disorders. The product is marketed by Pfizer in the United States under the trade name Zoloft(R). According to IMS, Dec. 2003, the market size of anti-depressant products in Spain is approximately $540 million and growing at an annual rate of 34%. In the Spanish market, sertraline accounts for approximately $102 million and has grown 33% over the past twelve months.
James R. Murphy, Bentley's President and CEO, commented, "We are pleased to add sertraline to our anti-depressant product lines, which include our recently announced generic approval of mirtazapine (equivalent to Remeron(R)), as well as generic fluoxetine (equivalent to Prozac(R)), and generic paroxetine (equivalent to Paxil(R)). Sertraline is scheduled for launch in the second half of 2004. This growing class of drugs has witnessed rapid uptake in the past few years and we look forward to furthering our marketing and sales presence in this space. We anticipate additional product approvals in Spain and the European Union."
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.
Copies of Bentley Pharmaceuticals' press releases and other information may be obtained through Bentley's web site at http://www.bentleypharm.com/.
Safe Harbor Statement under the Private Securities Litigation Reform Act 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 identifying suitable drugs for drug delivery technologies, expanding generic and branded drug operations, changes in third-party reimbursement and government mandates which impact pharmaceutical pricing, development and commercialization of our products, relationships with our strategic partners, uncertainty of clinical trials, regulatory approval process, product sales concentration, unpredictability of patent protection, technological changes, the effect of economic conditions and other uncertainties detailed in Bentley's filings with the Securities and Exchange Commission.
Bentley Pharmaceuticals, Inc.
CONTACT: Michael D. Price, Vice President, Chief Financial Officer ofBentley Pharmaceuticals, Inc., +1-603-658-6100; Investors - DeborahArdern-Jones or Jonathan Birt, or Media - Sean Leous, all of FinancialDynamics, +1-212-850-5600, for Bentley