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EU approvals for Bentley's venlafaxine, alendronate
Exeter, New Hampshire | Thursday, July 19, 2007, 08:00 Hrs  [IST]

Bentley Pharmaceuticals, Inc., a specialty pharmaceutical company, has announced the receipt of two product approvals in Europe. The company's subsidiaries in Spain, Laboratorios Belmac, Laboratorios Davur and Laboratorios Rimafar, received product approval for venlafaxine extended release from the Spanish Ministry of Health. The company's subsidiary in Ireland, Bentley Pharmaceuticals Ireland Ltd, has received approval for alendronate from the Irish Medicines Board.

Venlafaxine is the generic equivalent to the Wyeth Pharmaceuticals, Inc. product marketed in the US under the trade name Effexor, which is used in the treatment of depression. According to IMS Health, Inc., the annual market size in Spain for venlafaxine is approximately $118 million (USD) and grew by 6 per cent over the trailing twelve months.

Alendronate, often used in the treatment of bone loss, is the generic version of the product currently, marketed by Merck & Co., Inc. under the trade name Fosamax. IMS Health, Inc estimates the annual market for alendronate in Ireland is approximately $17 million (USD).

"Receiving these product approvals is another step forward in our strategy to strengthen our generics business in Spain while at the same time capitalizing on growth in demand for generic pharmaceuticals elsewhere in Europe," said John Sedor, president of Bentley Pharmaceuticals, Inc. "In Ireland and Spain, as in the rest of Europe and markets around the world, the costs associated with an aging population consuming an expanding range of pharmaceuticals are straining the healthcare system. Generics are becoming an increasingly attractive and acceptable way to contain these costs - especially given the large number of branded pharmaceuticals that have recently or soon will be going off patent. Our broad portfolio of commercialised generic pharmaceuticals and our pipeline of pending approvals position us to continue building Bentley's presence in the European generics market."

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 central nervous system diseases through its subsidiaries -- Laboratorios Belmac, Laboratorios Davur, Laboratorios Rimafar and Bentley Pharmaceuticals Ireland.

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