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Bentley receives approval for ulcer and osteoporosis drugs

Bentley Pharmaceuticals has announced that its European subsidiaries have received their first product approval for ulcer drug Lansoprazole, a generic version of Prevacid, in France. Bentley's Irish subsidiary also received approvals for marketing a generic version of a once-weekly dosage form of alendronate for treating osteoporosis, in Ireland.

Lansoprazole is used to treat gastrointestinal diseases including acid reflux and ulcers and is marketed under the trade name Prevacid in the US by TAP and in Europe by Takeda Pharmaceuticals. Alendronate is used in the treatment of osteoporosis and bone loss, and is the generic version of Fosamax, which is currently marketed by Merck & Company.

Lansoprazole is under patent protection in France until December 11, 2007. Bentley subsidiaries plan to be in the French market, through partners and licensees, at the time of market formation upon patent expiration. Firm orders have been received under long-term supply agreements and the finished products will be supplied in the fourth quarter from Bentley’s subsidiary manufacturing facilities in Spain.

John Sedor, president of Bentley Pharmaceuticals, said: “These recent approvals not only open additional major markets for the continued growth of our European business outside of Spain, but also enhance the value of our European operations. We expect to be filling orders for these products in France and Ireland in the fourth quarter. We are also expecting similar approvals in other major European markets in the near future.”