• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Bentley Announces Latest Marketing Approvals and Product Launch in EU

Posted on: Friday, 2 February 2007, 18:01 CST

Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company, today announced its latest product launch and marketing approvals in the European Union (EU). John Sedor, president of Bentley commented, "These approvals and product launch are consistent with our expansion strategy to increase our product portfolio in Spain while also accelerating our efforts into other EU markets."

Through the EU's Mutual Recognition Procedure (MRP), approval was granted to Bentley's wholly owned Spanish subsidiaries for lansoprazole in several European countries. Lansoprazole will be marketed through the Company's licensees and distributors where patents have expired. MRP is the process in the EU that allows for the coordination of product approvals between Member States, provided that the Member States apply harmonized conditions for use of the product. Bentley had previously reported approval of lansoprazole in the United Kingdom in 2005 under a national product approval procedure.

Separately, Bentley Pharmaceuticals Ireland Limited has received approval from the Irish Medicines Board to market lansoprazole 15 mg and 30 mg capsules. Lansoprazole is the generic version of Prevacid®, innovated by TAP Pharmaceuticals Products, Inc. Bentley Ireland has also launched its previously approved 10 mg, 20 mg and 40 mg capsules of omeprazole in Ireland. Omeprazole is the generic version of Prilosec®, innovated by AstraZeneca International. Both products will be distributed and promoted in Ireland by one of the country's largest pharmaceutical distributors.

Lansoprazole and omeprazole are proton pump inhibitors that are commonly used to treat gastrointestinal disorders such as duodenal and gastric ulcers, and gastroesophageal reflux disease. According to Irish General Medical Services (GMS) data, the annual market size in Ireland for omeprazole is approximately $30 million (USD), and approximately $20 million (USD) per year for lansoprazole.

The Company also noted that its subsidiary, Laboratorios Davur, S.L., has obtained approval to market lamotrigine from the Ministry of Health in Spain. Lamotrigine is the generic version of Lamictal®, an antiepileptic drug marketed by GlaxoSmithkline. According to IMS Health Inc., lamotrigine has an annual market size of approximately $48 million (USD) in Spain and grew at a rate of 5% over the trailing twelve months.

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

Additional information regarding Bentley Pharmaceuticals may be obtained through Bentley's web site at www.bentleypharm.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This press release contains forward looking statements, including without limitation, statements regarding Bentley's new product approvals in Europe and the size of the markets reported for such products. 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, changes in third party reimbursement and government mandates which impact pharmaceutical pricing, competition from other manufacturers of generic and proprietary pharmaceuticals, risks associated with the timing and nature of regulatory approvals, 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.

Source: Business Wire

More News in this Category