Healthcare Industry News: Perrigo
News Release - December 21, 2006
Bentley Pharmaceuticals' Generic Simvastatin Approved for U.S. Market
EXETER, N.H.--(HSMN NewsFeed)--Bentley Pharmaceuticals, Inc. (NYSE: BNT ), a specialty pharmaceutical company, announced today that its U.S. marketing partner, Perrigo Company, has received approval from the U.S. Food and Drug Administration (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, Zocor® (Merck & Co.), whose patent expired on June 23, 2006 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.
"We are pleased with the FDA's approval of our facility to manufacture our first generic drug for distribution in the U.S. market," said John A. Sedor, president of Bentley Pharmaceuticals. "This approval marks an important strategic milestone for Bentley."
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 manufactures and markets a growing portfolio of generic and branded generic pharmaceuticals in Europe for the treatment of cardiovascular, gastrointestinal, infectious and neurological diseases through its subsidiaries -- Laboratorios Belmac, Laboratorios Davur, Laboratorios Rimafar and Bentley Pharmaceuticals Ireland. Bentley also manufactures and markets active pharmaceutical ingredients through its subsidiary, Bentley API.
Additional information regarding Bentley Pharmaceuticals 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 Bentley's planned sale of generic simvastatin to Perrigo for distribution in the U.S and the prospects for revenue through sales to Perrigo. 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 commercialization of a generic product in a new market, competition from other manufacturers of generic and proprietary pharmaceuticals, 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.
Source: Bentley Pharmaceuticals
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