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.
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