Alimentary Health Ltd. receives orphan-drug designation for the treatment of pediatric ulcerative colitis
Cork, Ireland, 14 May, 2008: Alimentary Health Ltd. (Alimentary Health), the development stage specialty biotechnology company, today announces that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA), has granted orphan-drug designation to Bifidobacterium infantis 35624 for the treatment of pediatric ulcerative colitis (UC). This new orphan-drug designation builds on the previously granted designation to Alimentary Health for pediatric Crohn’s Disease (CD). UC and CD account for the disorders that represent the inflammatory bowel diseases (IBDs). The pediatric population is defined as patients who are age sixteen or less.
Ulcerative colitis is a disease characterised by remitting and relapsing inflammation of the large intestine. For the treatment of UC, doctors typically prescribe medicines to reduce inflammation or as immunosuppressives. The disease usually requires these treatments to induce remission but surgery is also occasionally necessary. Paediatric onset leads to a lifelong debilitating disease with significant quality of life implications for UC patients and their families.
Barry Kiely, CEO of Alimentary Health, commented, "the achievement of orphan-drug designation for one of our probiotic technologies is an important step towards having probiotics serve as drug treatment for certain gastrointestinal and inflammatory conditions. This is and will continue to be a key goal of our research efforts."
Alimentary Health is a leader in pioneering the development of safe and effective therapeutics for Gastrointestinal (GI) and other indications.
Contact Information:
Financial Dynamics: Deborah Scott/John Dineen, Tel: +44 (0) 20 7269 7182
About Alimentary Health:
Alimentary Health is a development stage specialty biotechnology company located in Ireland. The company is focused on the discovery, development and commercialisation of proprietary probiotic and pharmabiotic treatments for gastrointestinal disorders and other inflammatory conditions. Alimentary Health is the foundation industry partner of the Alimentary Pharmabiotic Center based at University College Cork, Ireland.
www.alimentaryhealth.ie |
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