Healthcare Industry News:  osteoporosis 

Biopharmaceuticals Generics Regulatory

 News Release - October 29, 2007

Bentley Announces Product Approvals in Spain and Ireland

Generic Versions of Fosamax(R) weekly, Mevacor(R), Vaseretic(R) and Prescription Versions of Glucosamine and Aceclofenac Approved in Spain; Irish Medicines Board Approves Generic Equivalent of Zocor(R)

EXETER, N.H.--(HSMN NewsFeed)--Bentley Pharmaceuticals, Inc. (NYSE: BNT ), a specialty pharmaceutical company focused on advanced drug delivery technologies and generic pharmaceutical products, today announced five generic product approvals from the Spanish Ministry of Health and an approval for simvastatin from the Irish Medicines Board.

In Spain, Laboratorios Davur, as well as two other Bentley subsidiaries, Laboratorios Rimafar and Laboratorios Belmac, received approval for alendronate weekly. 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, Inc. According to IMS Health, Inc., annual brand sales in Spain for alendronate weekly are approximately $89 million (USD).

Laboratorios Davur and Laboratorios Rimafar each received approvals in Spain for cardiovascular products including lovastatin 20 mg. and 40 mg. tablets, as well as enalapril in combination with hydrochlorothiazide (HCTZ). Lovastatin is marketed in the United States by Merck & Co. under the trade name Mevacor®, and is prescribed for control of cholesterol levels. The annual market size in Spain for lovastatin is approximately $14 million (USD), according to IMS Health. Enalapril with HCTZ is an anti-hypertensive medication combined with a diuretic. The product is marketed in the United States by Merck & Co. under the trade name, Vaseretic®. The Spanish market size for enalapril with HCTZ is approximately $34 million according to IMS Health.

Laboratorios Davur also received product approvals in Spain for glucosamine and aceclofenac. Glucosamine is a treatment for osteoarthritis available over-the-counter in the United States, but only by prescription in Spain. Aceclofenac is a non-steroidal anti-inflammatory prescribed as a treatment for diseases including osteoarthritis and rheumatoid arthritis. According to IMS Health, the annual markets for glucosamine and aceclofenac in Spain are approximately $39 million and $24 million (USD), respectively.

In Ireland, Bentley’s subsidiary, Bentley Pharmaceuticals Ireland, received approval to market generic simvastatin. The product will be manufactured at Bentley’s facilities in Spain. Simvastatin is the generic version of Zocor®, which is marketed in the United States by Merck & Co. The annual market for simvastatin in Ireland is estimated by IMS Health at approximately $10 million (USD) annually.

“Receiving multiple approvals in Spain and Ireland for these generic drugs strengthens our product portfolio, and is an important step forward in our strategy to grow within and outside of Spain by leveraging the low-cost, highly efficient manufacturing capabilities of our Spanish subsidiaries,” said John Sedor, president of Bentley Pharmaceuticals. “We look forward to capitalizing on future opportunities in the growing European generics market, and expect the benefits of these approvals and new launches to enhance our fourth quarter results.”

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. Bentley also manufactures and markets active pharmaceutical ingredients through its subsidiary, Bentley API. Additional information regarding Bentley Pharmaceuticals may be obtained through Bentley’s website at

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 new product approvals in Spain and Ireland, the potential impact of these approvals on Bentley's results of operations and Bentley’s opportunities in the European generics market. 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 the timing and nature of regulatory approvals, changes in third party reimbursement and government mandates which impact pharmaceutical pricing, 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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