EXETER, N.H. -- Bentley Pharmaceuticals, Inc. (NYSE: BNT), a technology-based specialty pharmaceutical and drug delivery company with a growing branded and generic product line in Europe, announced today that it has received approvals of generic versions of its lansoprazole formulations in the UK. Product launch in the UK market will begin immediately through its licensees.
Marketing approval has been granted by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the 15 mg. and 30 mg. dosage strengths of lansoprazole capsules, which will be supplied to licensees. According to industry sources, the annual market size of lansoprazole in the European Union is approximately $880 million, of which the UK accounts for approximately 45%, or approximately $400 million.
Lansoprazole belongs to a class of gastric acid-pump inhibitors that block the final step of acid production and is used to treat patients with ulcers and acid reflux disease. The branded product is marketed in the United States by TAP Pharmaceutical Products Inc. under the trade name Prevacid(R).
James R. Murphy, Bentley's Chairman and CEO, commented, "This is another complementary approval in the UK and further indication of Bentley's active strategy to expand into other EU countries. It also confirms our aggressive efforts to team with other market leading organizations to augment our growth in new territories." Murphy further commented, "Being aware of the December 2005 UK patent expiration and anticipating this approval, we have scaled up our manufacturing capacity to meet expected demand in this sizable market. We anticipate other EU approvals for this product as we progress into the new year."
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 Statement under the Private Securities Litigation Reform Act of 1995: This press release contains forward looking statements, including without limitation, statements regarding the approval and launch of our new lansoprazole products in the UK and other new product approvals expected in the UK and the rest of Europe, our growth plans and strategy, our manufacturing capacity and expected demand for our 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, 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 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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