The clinical study, run by P&G, aims to determine the efficacy of Asacol in the treatment of Acute Diverticulitis and whether supplementation with Bifidobacterium infantis 35624 provides additional benefit. This study is the first to be initiated as part of the Clinical Studies Agreement with P&G announced in August 2007. Under the terms of the agreement Alimentary Health is entitled to receive a milestone payment based upon clinical performance.
Asacol delayed-release tablets are a prescription product indicated in the US to treat mild to moderate flare-ups of ulcerative colitis and maintain remission. Bifantis, a probiotic strain, has been clinically proven to manage all of the cardinal symptoms of Irritable Bowel Syndrome (IBS) in two randomized studies published in Gastroenterology and The American Journal of Gastroenterology.
Barry Kiely, CEO of Alimentary Health, commented: "Commencing this important clinical study is another significant step for Alimentary Health. The study will further support the therapeutic benefits of Bifidobacterium infantis 35624 in GI. We are delighted to continue to work with P&G and look forward to progressing Alimentary Health's probiotic technology to its next stage."
Alimentary Health is a leader in pioneering the development of safe and effective therapeutics for Gastrointestinal (GI) and other indications.
About Alimentary Health
Alimentary Health is a development stage specialty biotechnology company located in Ireland. The company is focused on the discovery, development and commercialization 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.
About Procter & Gamble Pharmaceuticals
P&G Pharmaceuticals (P&GP), a division of The Procter & Gamble Company (NYSE: PG), has successfully developed and/or marketed a wide range of prescription products since the 1980s, including Actonel®, Asacol®, Enablex®, Dantrium®, Didronel®, and Macrobid®.. P&GP employs a Connect & Develop model for new product development and in-licenses or acquires 100 percent of its new drug candidates from biotech and pharmaceutical industry relationships. P&GP is committed to leveraging this model to build brands to address unmeet needs in the areas of gastrointestinal, musculoskeletal and women's health. The P&GP community consists of more than 3,000 employees working in over 22 countries worldwide. For more information on P&GP and its prescription product portfolio, please visit www.pgpharma.com. For full prescribing information on Asacol, please visit www.Asacol.com/pdf/us-asacol.pdf. Additional information about Asacol can be found by visiting www.Asacol.com
Three billion times a day, P&G brands touch the lives of people around the world. P&G has one of the strongest portfolios of quality, leadership brands in consumer health and wellness, including Align®, Always®, Crest®, Metamucil®, Oral-B®, Pepto-Bismol®, Prilosec OTC®, Scope®, Tampax®, and Vicks®, in addition to its trusted consumer brands, including Ariel®, Braun®, Bounty®, Charmin®, Dawn®, Downy®, Duracell®, Folgers®, Gillette®, Head & Shoulders®, Iams®, Lenor®, Mach3®, Olay®, Pantene®, Pampers®, Pringles®, Tide®, Wella®, and Whisper®. The P&G community consists of over 135,000 employees working in over 80 countries worldwide. Please visit http://www.pg.com for the latest news and in-depth information about P&G and its brands.
About Acute Diverticulitis
Diverticulitis is a common digestive disorder particularly found in the large intestine. It develops from diverticulosis, which involves the formation of pouches (diverticula) on the outside of the colon. Diverticulitis results if one of these diverticula becomes inflamed. An initial episode of acute diverticulitis is usually treated with conservative medical management, including bowel rest (i.e. nothing by mouth), IV fluid resuscitation, and broad-spectrum antibiotics which cover anaerobic bacteria and gram-negative rods. However, recurring acute attacks or complications, such as peritonitis, abscess, or fistula may require surgery, either immediately or on an elective basis.