Bifidobacteria infantis

Above: © Dr. Gary Gaugler / photoresearchers.com

Finding a route to market is often the biggest challenge for any small biotechnology firm. Alimentary Health, a spinoff from University College Cork (UCC), has found one of the best operators in the business to commercialize its knowledge of probiotic bacteria and host-microbial interactions in the intestine: Procter & Gamble's legendary marketing machine.

Procter & Gamble has already started a push on Alimentary's new probiotic brand, Align, which it is promoting as an aid to digestive health. Align, taken as a daily oral capsule, is being sold as an over-the-counter treatment for diarrhea, constipation, and other abdominal problems. At the core of the Align brand is a strain of lactic acid bacteria, Bifidobacterium infantis 35624, which was originally isolated at UCC.

"I don't think people like Procter & Gamble get in unless there's a pretty big market," says Seamus O'Hara, partner at Dublin-based Seroba Bioventures, an early-stage investor in the company. "It's a pretty important brand and product for them, by all accounts."

Alimentary Health's positioning in the emerging field of probiotics is distinctive. It is integrating its microbiological research with clinical research, which, eventually, could support the use of its probiotic strains in clinical settings. "It's not food. It's not pharma. It's somewhere in between," says Jack Gorman, biotechnology analyst at Dublin-based Davy Stockbrokers. "They're trying to raise the bar from a scientific perspective."

That effort is at a relatively early stage. The medical literature supporting the clinical use of probiotics is limited at present. However, the company and its academic collaborators have already published data from a 362-patient study indicating that B. infantis 35624 proved 20% more effective than placebo in improving symptoms of patients with irritable bowel syndrome (IBS) (Am J Gastroenterol,101:1581-90, 2006).

IBS has proven to be a minefield for several Big Pharma drug developers, including Novartis and GlaxoSmithKline, both of which have withdrawn products that had large expectations attached. Each company had attempted to ameliorate the symptoms of the condition by targeting serotonin receptors in the small intestine. Alimentary Health is working on the basis that IBS is associated with perturbations in the gut microflora. It is investigating the same principle in inflammatory bowel disease and in other conditions.

Both Alimentary Health and Procter & Gamble are founding partners in the Alimentary Pharmabiotic Center at UCC, one of the flagship Centers for Science, Engineering and Technology funded by Science Foundation Ireland. The Pharmabiotic center's basic mission is to explore the influence of intestinal bacteria on human health and disease. It marries the clinical expertise of director Fergus Shanahan and principal investigator Eamonn Quigley, two renowned gastroenterologists who accepted positions at UCC in the 1990s.