Bentley gets clearance to manufacture, market generic enalapril in Spain

The Spanish Ministry of Health has granted two Bentley Pharmaceuticals Inc. (North Hampton, NH) subsidiaries approval to manufacture and market generic versions of enalapril in Spain. Laboratorios Belmac received authorization for 5 mg and 20 mg dosage forms; Laboratorios Davur received approval for the 5 mg and 20 mg tablets. Bentley plans to launch the products during the fourth quarter of 2000.

Bentley's enalapril formulations are generically equivalent to Merck's Vasotec and Laboratorios Belmac's Controlvas, which achieved 1999 sales of over $2.5 million. The drug belongs to a class of ACE inhibitor compounds used for treating cardiovascular disease and hypertension. Laboratorios Belmac will manufacture the products at its production facility in Zaragoza, Spain.

In a company press release, Bentley chairman and CEO James R. Murphy stated that, according to the IMS, the Spanish market for this therapeutic class of drugs is approximately $180 million, and enalapril products have captured approximately 50% of the market. Generic versions of enalapril have grown at a rate of 50% over the trailing 12 months, he added.

Bentley Pharmaceuticals Inc. is a drug delivery company focused upon improving the absorption of a range of drugs and peptides through proprietary drug delivery technologies.

For more information: Michael D. Price, Bentley Pharmaceuticals Inc., 65 Lafayette Rd., 3 Fl., North Hampton, NH 03862. Tel: 603-964-8006. Fax: 603-964-6889.

Edited by Jim Pomager
Assistant Editor, Pharmaceutical Online