Bentley Announces Latest Marketing Approvals and Product Launch in EU.MRP (Material Requirements Planning) An information system that determines what assemblies must be built and what materials must be procured in order to build a unit of equipment by a certain date. Approval for Lansoprazole in EU Omeprazole Launched in the Irish Market Lamotrigine Approved 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 company, today announced its latest product launch and marketing approvals in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community (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([R]), 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([R]), 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 Proton Pump Inhibitors Definition The proton pump inhibitors are a group of drugs that reduce the secretion of gastric (stomach) acid. They act by binding with the enzyme H+, K(+)-ATPase, hydrogen/potassium adenosine triphosphatase that are commonly used to treat gastrointestinal disorders such as duodenal duodenal /du·o·de·nal/ (doo?o-de´n'l) (doo-od´ah-n'l) of or pertaining to the duodenum. Duodenal Refers to the duodenum, or the first part of the small intestine. and gastric ulcers, and gastroesophageal reflux disease gastroesophageal reflux disease (GERD) Disorder characterized by frequent passage of gastric contents from the stomach back into the esophagus. Symptoms of GERD may include heartburn, coughing, frequent clearing of the throat, and difficulty in swallowing. . According to Irish General Medical Services Despite many different contracting arrangements that have been and are being introduced for general medical service in the UK, General Practitioners (GPs) are, in principle, independent contractors with the government. (GMS GMS Greater Mekong Subregion GMS Global Mobile (Communications) System GMS Guild Management System GMS General Medical Services GMS Global Management System (Sonicwall) GMS GroupWise Mobile Server ) data, the annual market size in Ireland for omeprazole is approximately $30 million (USD USD In currencies, this is the abbreviation for the U.S. Dollar. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. ), 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([R]), 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 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). . 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 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 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. |
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