ExeGi Pharma Launches Visbiome™ Probiotic

Extensively-Studied De Simone Formulation Now Available

01 Feb, 2016, 08:00 ET from ExeGi Pharma

GAITHERSBURG, Md., Feb. 1, 2016 /PRNewswire-USNewswire/ -- ExeGi Pharma, LLC announced the launch of the new probiotic formulation, Visbiome™ and Visbiome™ Extra Strength. Visbiome contains the pioneering probiotic blend developed by Professor Claudio De Simone, M.D., Ph.D. (the "De Simone Formulation"), and it has the same strains, in the same concentrations and proportions, and is therapeutically equivalent to the VSL#3®1 probiotic blend produced before January 31, 2016. Visbiome, a medical food, delivers anti-inflammatory probiotic bacteria in high concentrations, normalizing the gut flora and providing sustained relief from symptoms of multiple gastroenterological conditions including ulcerative colitis, chronic pouchitis and irritable bowel syndrome (IBS).

"More than 20 years ago, I created my probiotic formulation with the aim of helping patients manage complex conditions and support a healthy microbiome," said De Simone, chief medical officer of ExeGi Pharma. "The benefits of this formulation have been demonstrated in rigorous research again and again, and I am pleased to partner with ExeGi Pharma to ensure continued access to the probiotic blend that patients and their healthcare professionals trust."  

The De Simone Formulation is one of the few probiotic blends that has undergone rigorous double-blind, placebo-controlled scientific trials, tested in over 60 peer-reviewed studies. Researchers continue to investigate the potential benefits of the De Simone Formulation in more than 20 trials around the globe, and Visbiome will be the subject of a new clinical trial funded by the NIH's National Institute of Allergy and Infectious Diseases (NIAID) to explore its therapeutic impact on people living with HIV.

Professor De Simone initially partnered with VSL Pharmaceuticals, Inc. to produce and market his proprietary blend of probiotic strains under the designation "VSL#3," which is a registered  trademark owned by VSL Pharmaceuticals, Inc. Professor De Simone is now collaborating exclusively with ExeGi Pharma to produce Visbiome and Visbiome Extra Strength. The license agreement between Professor De Simone and VSL Pharmaceuticals, Inc., which provided VSL Pharmaceuticals, Inc. the rights to market the De Simone Formulation using the "VSL#3" trademark, expired on January 31, 2016.

"Patients who are managing conditions like ulcerative colitis, pouchitis and IBS often face a roller-coaster ride of ups and downs," said Martin Floch, M.D., clinical professor of medicine at Yale and editor-in-chief of the Journal of Clinical Gastroenterology. "In my clinical practice, I've seen first-hand how the De Simone Formulation has helped my patients achieve stability in their conditions. It's so important that they can continue to access the formulation that we both trust and that's yielded tangible results."

In launching Visbiome, ExeGi has developed important product support features including:

  • The ExeGi Direct Access reimbursement support hotline, which will help patients obtain insurance coverage for Visbiome Extra Strength
  • Capsules packaged in state-of-the-art Active-Vials, which ensure minimal moisture intrusion and enhanced product potency

"As an academic research gastroenterologist, it gives me a great deal of confidence knowing that patients will have access to such an extensively and rigorously tested product," said Claudio Fiocchi, M.D., an international authority in the field of inflammatory bowel disease (IBD) and professor of molecular medicine, Lerner College of Medicine and Department of Gastroenterology & Hepatology at the Cleveland Clinic Foundation. "Professor De Simone's commitment to maintaining the integrity of his blend means that the known therapeutic effects of his original probiotic formulation will continue to be available to patients with a vast range of gastrointestinal ailments." 

Both Visbiome and Visbiome Extra Strength are medical foods to be used under physician supervision and Visbiome Extra Strength requires a prescription. Visbiome is available at www.visbiome.com and Visbiome Extra Strength can be special ordered at any pharmacy or purchased directly through ExeGi Direct Access at 844-348-4887. For more information, please visit www.visbiome.com.

About Visbiome™
Visbiome™ is a probiotic consisting of eight strains of live, freeze-dried lactic acid bacteria. Data show that the De Simone Formulation, now found in Visbiome, is effective in the dietary management of ulcerative colitis, pouchitis and irritable bowel syndrome (IBS). The formulation that makes up Visbiome is currently being investigated in more than 20 trials around the globe. Visbiome Extra Strength is a prescription-only medical food. Patients should consult with a physician before taking Visbiome. Visbiome is manufactured exclusively for ExeGi Pharma, LLC and is not affiliated with, endorsed by, or distributed by VSL Pharmaceuticals, Inc.

About ExeGi Pharma
ExeGi Pharma, LLC is a biotechnology company focused on the development and commercialization of live biotherapeutic and probiotic medicines. ExeGi's team leverages the growing advances in the field of microbiome science to deliver novel clinically supported live biotherapeutic and probiotic treatments for a wide variety of unmet medical needs. ExeGi is not affiliated with VSL Pharmaceuticals, Inc.

1 VSL#3 is a registered trademark of VSL#3 Pharmaceuticals, Inc. and is manufactured exclusively for VSL Pharmaceuticals, Inc. Visbiome is manufactured exclusively for ExeGi Pharma, LLC and is not affiliated with, endorsed by, or distributed by VSL Pharmaceuticals, Inc.

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SOURCE ExeGi Pharma