News Release

New VSL#3® JUNIOR probiotic for children now available

VSL#3® JUNIOR, a welcome adjunct to the therapeutic strategies for children with IBS

Business Announcement

Robin Leedy & Associates, Inc.

GAITHERSBURG, MD, August 7, 2012 – Sigma-Tau Pharmaceuticals, Inc., is excited to introduce a new probiotic medical food for children with IBS. A study published in the Journal of Pediatric Gastroenterology and Nutrition (1) , found that VSL#3®, a high-potency probiotic medical food, provided a beneficial role in the dietary management of children who suffer from irritable bowel syndrome (IBS), a common problem for which there is no cure. This finding led Sigma-Tau, distributor of VSL#3, to develop and introduce new VSL#3 JUNIOR; a high-potency probiotic medical food for the dietary management of irritable bowel syndrome (IBS) and ulcerative colitis (UC) in children. New VSL#3 JUNIOR is now available through participating pharmacies behind the counter.

"One of the most obscure consequences of IBS in children is the way these conditions affect their entire family," expresses Mary Ocnean, senior product manager at Sigma-Tau Pharmaceuticals. "VSL#3 has been clinically proven to provide significant improvement in family life disruption scores and in reducing the discomfort and bloating of IBS. It is the first probiotic medical food that has been studied in a pediatric, randomized, double-blind, placebo-controlled crossover trial for children. It was a natural next step for us to extend the line of VSL#3 products with a pediatric version and we're happy to announce that it is now available to consumers in a once daily formulation," adds Ocnean.

Unlike other probiotics, VSL#3 JUNIOR is a medical food and requires refrigeration to preserve its 8 proprietary strains of 225 billion live bacteria, making it one of the few probiotics with this many strains and about 50 times more potent than the average probiotic (2) . VSL#3 JUNIOR is all-natural and comes in watermelon, a kid-pleasing flavor, making compliance less of an issue.

"There has been extensive clinical research in patients who added VSL#3 to their daily regimen, and the evidence shows that this probiotic plays a beneficial role in the dietary management of children suffering with IBS and UC (3) . IBS patients receiving VSL#3 also had significantly greater improvements versus both baseline and placebo in discomfort, bloating, gassiness and family assessment of life disruption (1). For young patients with UC, VSL#3 JUNIOR offers a tasty alternative to current VSL#3 products," says Ocnean. VSL#3 JUNIOR can be mixed into cold drinks, such as water and juice or foods like applesauce or ice cream, making it easy for children who find taking medication difficult. Adjustment of the intestinal flora can take a few days or weeks; it may take up to one month for the colonization of the gut to become optimally stable. All natural VSL#3 JUNIOR is gluten free, is Kosher and Halal certified, and a non-dairy product. Each box contains 30 watermelon flavored packets. As with all forms of VSL#3, they must be used under medical supervision.

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VSL#3 products are available behind the pharmacy counter at pharmacies nationwide. In addition to VSL#3 JUNIOR, there are three other formulations for adults: VSL#3 DS prescription-only medical food packets containing 900 billion bacteria, VSL#3 packets containing 450 billion bacteria, and VSL#3 capsules containing 112.5 billion bacteria. Physicians and pharmacists interested in additional information about the product can visit www.vsl3.com or call 1-866-634-2765. Patients and consumers may call 1-866-GET-VSL3 or visit www.vsl3.com for more information.

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1. Guandalini et al. Journal of Pediatric Gastroenterology and Nutrition; July 2010: 51(1); 24-30

2. Based on CFU count: IRI Retail Data for 52 weeks ending 12.25.11

3. Miele et al: American Journal of Gastroenterology. 2009; 104(2); 4437-443


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