FDA Grants Orphan Drug Designation For EUR-1073 - Ulcerative Colitis For Pediatric Patients

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Pediatrics / Children's Health;  Regulatory Affairs / Drug Approvals
Article Date: 19 Mar 2009 - 5:00 PST

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Eurand N.V. (NASDAQ: EURX), a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies, announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for EUR-1073 (beclomethasone diproprionate) in pediatric patients. EUR-1073 is a proprietary development product for the treatment of ulcerative colitis.

Orphan drug status is granted by the FDA to promote the development of drugs for diseases that affect fewer than 200,000 patients. Products granted orphan drug status are allowed seven years of market exclusivity in the U.S. upon FDA approval.

"We are pleased with the FDA's decision, and we believe EUR-1073 has the potential to address key unmet medical needs of pediatric patients with ulcerative colitis," said Gearoid Faherty, Chairman and Chief Executive Officer. "The development of EUR-1073 is part of our strategy to develop a pipeline of gastroenterology products to be marketed by our own sales force, and we believe it would be complementary to EUR-1008, currently under review by the FDA as a treatment for exocrine pancreatic insufficiency, a digestive disease."

In April 2008, Eurand acquired from Chiesi Pharmaceutici SpA the exclusive U.S. and Canadian rights to market EUR-1073, an enteric-coated, controlled-release formulation of beclomethasone diproprionate, which Chiesi markets as CLIPPER(TM) in several European countries for use in the treatment of ulcerative colitis.

About Ulcerative Colitis

Ulcerative colitis is a type of inflammatory bowel disease that produces inflammation and ulcers along the inside of the large intestine. The inflammation can interfere with the normal function of the colon, often causing cramping, bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements which seriously affect quality of life. Ulcerative colitis is a chronic relapsing/remitting illness for which there is no known cure: however, patients can manage their symptoms. A known issue that arises with ulcerative colitis patients is medication compliance and excessive pill burden: many currently available ulcerative colitis treatments require multiple, large pills to be taken several times daily, and inconvenient means of administration are often involved.

About Eurand

Eurand is a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies. Eurand has had four products approved by the FDA since 2001 and has a pipeline of product candidates in development for itself and its collaboration partners. Its technology platforms include bioavailability enhancement of poorly soluble drugs, custom release profiles, taste-masking orally disintegrating tablet (ODT) formulations, and drug conjugation.

Forward-Looking Statement

This release, and oral statements made with respect to information contained in this release, constitutes forward-looking statements. Such forward-looking statements include those which express plan, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact including, but not limited to the future and status of the Company's regulatory filings for EUR-1008, anticipated product launches, enrollment and future plans for its clinical trials, progress of and reports of results from clinical studies, clinical development plans and product development activities. The words "potentially," "anticipates," "could," "calls for" and similar expressions also identify forward-looking statements. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Factors that could affect actual results include risks associated with the possibility that the FDA does not approve the Company's NDA relating to EUR-1008; the outcome of any discussions with the FDA; and unexpected delays or additional requirements in preparation of materials for submission to the FDA as a part of the Company's NDA filing, including those relating to Eurand's raw material supplier. Investors are advised to refer to the Company's Risk Factors set forth in its Annual Report on Form-20-F as filed with the U.S. Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Actual events could differ materially from those anticipated in the forward-looking statements.

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Eurand N.V.