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GEN News Highlights : Dec 22, 2006

Bentley Pharmaceuticals’ Generic Simvastatin Approved for U.S. Market

Manufacturing is already under way to allow for immediate distribution in the U.S.

Bentley Pharmaceuticals’  U.S. marketing partner, Perrigo, received approval from the U.S. FDA to market generic simvastatin 5-mg, 10-mg, 20-mg, 40-mg and 80-mg tablets in the U.S. The FDA has determined that these formulations, which will be manufactured at Bentley’s facilities in Spain, are bioequivalent and have the same therapeutic effect as that of the reference drug, Merck’s Zocor®, whose patent expired in June and 180-day exclusivity period expired on December 19, 2006.

The FDA also completed its evaluation and approval of the Bentley manufacturing facility for the production and supply of simvastatin for the U.S. market. In anticipation of this approval, Bentley has already commenced the manufacturing of simvastatin tablets to allow for immediate distribution in the U.S. There can be no assurance of what the sales levels or pricing will be upon formation of the market for generic simvastatin.