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• EUR-1008 (U.S.)
• EUR-1008 (Ex-U.S.)
• EUR-1000
• EUR-1073
• EUR-1025

EUR-1073

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Controlled-release formulation of beclomethasone dipropionate, a corticosteroid used in the treatment of ulcerative colitis, one of the two most prevalent forms of inflammatory bowel disease

About EUR-1073

Chiesi Farmaceutici SpA has granted Eurand an exclusive license in the U.S. and Canada for an enteric-coated, controlled-release formulation of beclomethasone dipropionate, a corticosteroid marketed in Europe for use in the treatment of ulcerative colitis, one of the two most prevalent forms of IBD.

Beclomethasone dipropionate is a widely used anti-inflammatory corticosteroid for the treatment of asthma and allergic rhinitis. The product is currently approved and marketed in the United Kingdom, Italy, Spain, and Belgium as Clipper™ 5 mg tablets. 

Eurand has been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA) for EUR-1073 in pediatric patients. Products granted orphan drug status are allowed 7 years of market exclusivity in the U.S. upon FDA approval.

Competitive Advantage

Corticosteroids, as single agents or in combination, are effective treatment options for IBD such as ulcerative colitis and Crohn's disease; however, corticosteroids, including the most frequently used treatment, prednisone, are associated with significant side effects due to systemic absorption. The systemic absorption of beclomethasone dipropionate is lower than that of classical corticosteroids, such as prednisone.

This product, which Eurand has labeled EUR-1073, was developed using a drug-delivery system that targets the site of action, or the lower GI tract, and provides for a sustained release of drug upon delivery. This technological approach aims to preserve the efficacy of classical corticosteroids while reducing the side effects commonly associated with their use.