Public Release:  Maker of VSL#3 probiotic offers assistance program for ulcerative colitis and ileal pouch patients

Sigma-Tau Pharmaceuticals Sponsors program for prescription-only medical food - VSL#3® DS -- for dietary management of UC and ileal pouch

Robin Leedy & Associates, Inc.

GAITHERSBURG, MD, January 31 - People who have Ulcerative Colitis (UC) or Ileal Pouch know that finding the right regimen for extending their time between flares is crucial to successfully living with the condition. The solution is often a personalized combination of drugs, dietary changes and, for many, the addition of VSL#3®, a probiotic medical food designated for the dietary management of these conditions. Now, Sigma-Tau Pharmaceuticals, Inc., maker of VSL#3 medical food is sponsoring a Patient Assistance Program (PAP) to help in-need patients obtain its prescription-only double strength formulation VSL#3 DS.

The VSL#3 DS Patient Assistance Program is one of the first to provide assistance for a probiotic preparation. Sigma-Tau created this program in reaction to patient response to the product.

"We hear from many patients that VSL#3 DS is integral in the routine they adhere to in order to manage their diets," said Mary Berry, senior product manager at Sigma-Tau. "While this product is covered as a Tier 3 co-pay in many prescription plans, there are still many patients who do not have coverage and cannot afford to keep using it. We want to change that and make sure people who depend on VSL#3 DS can obtain it."

VSL#3 stands apart from other probiotics since it is not a supplement - it is a refrigerated medical food. It is one of the few probiotic preparations supported by Level 1 (double-blind, placebo-controlled) scientific data, and has been the subject of a collection of more than 80 studies that have demonstrated its application in the dietary management of IBS, Ulcerative Colitis, and Ileal Pouch.

VSL#3 DS delivers 900 billion bacteria per packet (up to 22.5 times more potent than the average probiotic) and consists of 8 strains of live, freeze-dried lactic acid bacteria. It is the only probiotic recognized as an effective tool in the dietary management of ileal pouch by the American College of Gastroenterology1 and by the Cochrane Review2.

The VSL#3 DS PAP varies with each patient depending on individual evaluation. The eligibility criteria for this program is that the patient must have an applicable diagnosis or physician referral, be a legal U.S. resident, and must meet a financial need criteria.

Decisions for coverage are usually announced within two business days after applying. The product is shipped directly to the patient, and one can reapply for assistance every November to ensure continued supply of the probiotic.

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To apply for assistance or contact a representative with questions about the program, patients call 1‑877‑279‑2459.

VSL#3 products are available online at http://www.vsl3.com, as well as behind the pharmacy counter at pharmacies nationwide. There are three formulations: VSL#3 DS prescription-only medical food packets, VSL#3 packets, and VSL#3 capsules. Physicians and pharmacists interested in additional information about the product can call 1-866-634-2765 and consumers may call 1-866-GET-VSL3 or visit http://www.vsl3.com for more information.

1Kornbluth, A, Sachar DB. Ulcerative colitis practice guidelines in adults: American College of Gastroenterology, Practice Parameters Committee.; Practice Parameters Committee of the American College of Gastroenterology. AM J. Gastroenterol. 2010 Mar; 105(3):501-23. 2Holubar SD et al., (Review) The Cochrane Library 2010, Issue 6.

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