Bentley Pharmaceuticals Inc., a specialty pharmaceutical company, announced that its European subsidiaries have received approvals to market their omeprazole capsule products, through their licensees, in various territories in Europe.
The approvals are for 10 mg. 20 mg. and 40 mg. dosage levels of omeprazole capsules under a Mutual Recognition Procedure (MRP) that grants simultaneous authorizations throughout the EU. Bentley's subsidiaries expect to supply omeprazole to their licensees in the major markets of Germany and Italy, as well as other EU countries. Omeprazole is marketed in the United States under the trade name Prilosec by AstraZeneca and under the trade name Losec in Europe.
The manufacture and supply of the finished products will be through Bentley's subsidiary, Laboratorios Belmac. The company plans to begin supplying omeprazole to licensees during the first quarter of 2008.
Jim Murphy, chairman & chief executive officer of Bentley Pharmaceuticals said, "Representing our first product entry into the major European markets of Germany and Italy, these approvals follow the November 2007 announcement of our entrance into France by way of similar agreements to distribute lansoprazole. We expect that these MRP approvals, together with other MRP registrations pending, will grow our specialty generic revenues outside of Spain by approximately 25% in 2008."
Murphy continued, "We have made the expansion of our products into major European markets beyond Spain a primary objective over the past few years, and receiving these multiple approvals is a milestone in that initiative. We look forward to further enhancing the value of our European operations by capitalizing on additional opportunities in these larger EU markets."
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 plans to spin off its drug delivery business as an independent, publicly traded company.