12.12.2005 13:00:00
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Bentley Pharmaceuticals Announces the Marketing Approval of Lansoprazole in the UK; December 12, 2005 Launch is Scheduled Through Its Licensees
Marketing approval has been granted by the Medicines andHealthcare Products Regulatory Agency (MHRA) for the 15 mg. and 30 mg.dosage strengths of lansoprazole capsules, which will be supplied tolicensees. According to industry sources, the annual market size oflansoprazole in the European Union is approximately $880 million, ofwhich the UK accounts for approximately 45%, or approximately $400million.
Lansoprazole belongs to a class of gastric acid-pump inhibitorsthat block the final step of acid production and is used to treatpatients with ulcers and acid reflux disease. The branded product ismarketed 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 isanother complementary approval in the UK and further indication ofBentley's active strategy to expand into other EU countries. It alsoconfirms our aggressive efforts to team with other market leadingorganizations to augment our growth in new territories." Murphyfurther commented, "Being aware of the December 2005 UK patentexpiration and anticipating this approval, we have scaled up ourmanufacturing capacity to meet expected demand in this sizable market.We anticipate other EU approvals for this product as we progress intothe new year."
Bentley Pharmaceuticals, Inc. is a specialty pharmaceuticalcompany focused on advanced drug delivery technologies andpharmaceutical products. Bentley's proprietary drug technologiesenhance or facilitate the absorption of pharmaceutical compoundsacross various membranes. Bentley also manufactures a growingportfolio of generic and branded pharmaceuticals in Europe for thetreatment of cardiovascular, gastrointestinal, infectious andneurological diseases through its subsidiary, Laboratorios Belmac, andmarkets these pharmaceutical products through its subsidiaries,Laboratorios Belmac, Laboratorios Davur, Laboratorios Rimafar andBentley Pharmaceuticals Ireland; and manufactures and markets activepharmaceutical ingredients through its subsidiary, Bentley API.
Copies of Bentley Pharmaceuticals' press releases and otherinformation may be obtained through Bentley's web site atwww.bentleypharm.com.
Safe Harbor Statement under the Private Securities LitigationReform Act of 1995: This press release contains forward lookingstatements, including without limitation, statements regarding theapproval and launch of our new lansoprazole products in the UK andother new product approvals expected in the UK and the rest of Europe,our growth plans and strategy, our manufacturing capacity and expecteddemand for our products. These forward-looking statements are subjectto a number of risks and uncertainties that could cause actual resultsto differ materially from future results expressed or implied by suchstatements. Factors that may cause such differences include, but arenot limited to, risks associated with the timing and nature ofregulatory approvals, changes in third party reimbursement andgovernment mandates which impact pharmaceutical pricing, competitionfrom other manufacturers of generic and proprietary pharmaceuticals,risks associated with international operations and other uncertaintiesdetailed in Bentley's most recent Annual Report on Form 10-K and itsother subsequent periodic reports filed with the Securities andExchange Commission. Bentley cautions investors not to place unduereliance on the forward- looking statements contained in this release.These statements speak only as of the date of this document, andBentley undertakes no obligation to update or revise the statements,except as may be required by law.
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