ExeGi Pharma Secures Canadian Approval For Well Studied Probiotic

GAITHERSBURG, Md., July 1, 2015 /CNW/ -- ExeGi Pharma, a company focused on developing and commercializing live biotherapeutics and probiotic treatments, announced today that it has been granted a product license by the Health Canada Natural and Non-prescription Health Products Directorate (NNHPD) to sell Visbiome™ in Canada.

Visbiome was developed by Professor Claudio De Simone, MD, PhD and has been the subject of extensive clinical investigation. Professor De Simone recently signed an exclusive agreement with ExeGi Pharma to produce Visbiome, a generic formulation of the probiotic marketed under the name VSL#3®*.

The Visbiome formulation is one of the few probiotic preparations to be rigorously researched using double-blind, placebo-controlled scientific trials, and has been the subject of nearly 60 published clinical trials in human subjects (with clinical trials conducted using the brand name VSL#3®.

Visbiome contains the same strains, in the same concentrations and proportions, as the original VSL#3® brand probiotic blend, and will be produced using the same manufacturing facility, methods and quality standards as the original product. The Visbiome formulation is approved in Canada to reduce the risk of relapse in pouchitis patients and to be used in conjunction with mesalamine to reduce the Ulcerative Colitis Disease Activity Index in patients with mild to moderate active ulcerative colitis.

"We appreciate the efficient review by NNHPD and know that the extensive body of research available on this probiotic formulation supported the process," said Marc Tewey, chief executive officer of ExeGi Pharma. "Physicians depend on this formulation to manage challenging health conditions and we look forward to launching a generic option of this product for patients in Canada."

"For patients managing a digestive health condition, it's important to have continuity in treatment. The launch of Visbiome will mean ongoing access for Canadian patients to formulations that many have used for years to manage pouchitis and ulcerative colitis," said Richard Fedorak, MD, FRCPC, Professor of Medicine in the Division of Gastroenterology, University of Alberta.

Visbiome will become available for sale in Canada by fall 2015 through pharmacies and on the Visbiome website. For more information, please visit www.exegipharma.com.

*VSL#3® is a registered trademark of VSL Pharmaceuticals, Inc.

About Visbiome™
Visbiome, manufactured and marketed under the brand name VSL#3® for almost 15 years, is one of the most rigorously studied probiotics available, making it a trusted formulation for both health care professionals and patients. Visbiome is a probiotic consisting of eight strains of live, freeze-dried lactic acid bacteria. Visbiome contains the same strains, in the same concentrations and proportions, as the original VSL#3® brand probiotic blend. Data show that the Visbiome's formulation is effective in the management of ulcerative colitis, pouchitis and other conditions. The formulation that makes up Visbiome is currently being investigated in more than 20 trials around the globe. Patients should consult with a physician before taking Visbiome.

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 scientific expertise in the field of microbiome science to deliver novel, clinically-supported live biotherapeutic and probiotic treatments for a variety of unmet medical needs. ExeGi is headquartered in Gaithersburg.

About Claudio De Simone
Claudio De Simone, MD, PhD, is an internationally recognized scientific leader in the field of probiotics and the human gut microflora. Professor De Simone invented the formulation of the probiotic tested and marketed under the name VSL#3®, which has been the subject of 60 clinical trials and is used for the dietary management of pouchitis, IBD and IBS. In addition, Professor De Simone has authored over 200 published scientific articles, reviews, case reports and book chapters.


SOURCE ExeGi Pharma

For further information: Jennifer Glicoes, 202-591-4048, jennifer@jpa.com, http://www.exegipharma.com/

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