PHILADELPHIA, April 15, 2008 (PRIME NEWSWIRE) -- Eurand N.V. (Nasdaq:EURX), a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies, announced today that Chiesi Farmaceutici SpA, an Italian pharmaceutical company, has granted Eurand Pharmaceuticals Inc. (Eurand), Affiliate of Eurand N.V., an exclusive license to its gastro-resistant, controlled release tablet formulation of the corticosteroid, beclomethasone dipropionate, in the United States and Canada. The product is currently approved and marketed in the United Kingdom, Italy, Spain, and Belgium.
Eurand will make an up-front payment and commercial milestone payments to Chiesi Farmaceutici, primarily contingent upon obtaining U.S. regulatory approval for the product. In addition, Eurand will pay royalties on net sales of the product.
The product, marketed in Europe as Clipper(tm) 5 mg tablets, is an enteric coated, controlled release formulation of beclomethasone dipropionate, a corticosteroid which is marketed in Europe for use in the treatment of Ulcerative Colitis, the most prevalent type of inflammatory bowel disease (IBD). Beclomethasone dipropionate is a widely used anti-inflammatory corticosteroid for the treatment of asthma and allergic rhinitis.
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.
Eurand's newly licensed product was developed using a drug delivery system that targets the site of action, or the lower gastrointestinal (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.
The recent 2006 position statements of the American Gastroenterological Association(1) and the 2006 guidelines from the European Crohn's and Colitis Organization(2) now list delayed release corticosteroids with a reduced systemic availability as a first line treatment recommendation for a majority of Crohn's disease patients.
Gearoid Faherty, Chief Executive Officer of Eurand, commented, "We believe this product's potential favorable efficacy and side effect profile could offer significant benefits and a new option to the 1.3 million U.S. patients who suffer from IBD. Gaining this important product helps to strengthen our product pipeline and highlights our commitment to building a GI franchise. Subject to approval, we intend to offer EUR-1008 (Zentase), our lead product candidate, to specialist GI physicians for the treatment of chronic pancreatitis and we believe Clipper(tm) would be an ideal product to provide to the same physicians. We look forward to working with the FDA to establish a clinical development and regulatory pathway for this product in the United States."
Alberto Chiesi, CEO of Chiesi Group, underlined that, "The opportunity to outlicense Clipper to Eurand for the U.S. and Canadian markets is in line with the Group strategy to co-operate with selected partners in order to extend the presence of our products and meet still unmet medical needs."
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, diarrhoea, bleeding, fatigue, weight loss and frequent bowel movements which seriously affect quality of life. It is believed that approximately 1.3 million people in the United States have IBD. 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 Chiesi
Chiesi Farmaceutici is a European pharmaceutical group, headquartered in Parma, Italy with a turnover of EUR 656 million in 2007. Chiesi has marketing and sales organizations in all major European markets, Eastern Europe, Russia and other countries and product distribution in over 40 countries and employs 3000 people worldwide, including approximately 300 scientists in research facilities in Italy, France and the U.S. Chiesi is developing innovative products aimed at the effective treatment of respiratory diseases and rare pathologies.
Chiesi's news releases and other information are available on the company's website at www.chiesigroup.com.
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 partnered products approved by the FDA since 2001 and has a pipeline of product candidates in development for itself and its collaboration partners. Eurand has completed two phase III clinical trials on its lead product candidate, EUR-1008 (Zentase), intended for the treatment of Exocrine Pancreatic Insufficiency and has submitted an NDA for this product which has been granted priority review. Eurand's technology platforms include bioavailability enhancement of poorly soluble drugs, customized release, taste-masking/fast-dissolving formulations and drug conjugation.
Eurand is a global company with facilities in the USA and Europe. For more information, visit Eurand's website at www.eurand.com.
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 our plans for our NDA filing, enrollment and future plans for our clinical trials, progress of and reports of results from clinical studies, clinical development plans and product development activities. The words "potentially," "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 refuses to approve our NDA; the outcome of any discussions with the FDA; and unexpected delays in preparation of materials for submission to the FDA as a part of our NDA filing. Forward-looking statements contained in this press release are made as of this date, and we undertake 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.
(1) Lichtenstein GR, Abreu MT, Cohen R, Tremaine W. American Gastroenterological Association Institute Technical Review on Corticosteroids, Immunomodulators, and Infliximab in Inflammatory Bowel Disease. Gastroenterology 2006;30:940-987.
(2) Travis SPL, Strange EF, Lemann M, Oresland T, Chowers Y, Forbes G, D'Haens G, Kitis G, Cortot A, Prantera C, Marteau P, Colombel J-F, Gionchetti P, Bouhnik Y, Tiret E, Kroesen J, Starlinger M, Mortensen NJ, for the European Crohn's and Colitis Organisation (ECCO). European evidence based consensus on the diagnosis and management of Crohn's disease: current management. Gut 2006;55(Suppl 1):i16-i35.