BELLUS Health (International) Limited, a wholly owned subsidiary of BELLUS Health Inc., today announced that the Italian Ministry of Health has granted a certificate of free sale for VIVIMIND(TM) (homotaurine) as a food supplement. A certificate of free sale in Italy permits the commercial sale of the product in that country. This certificate opens up means by which to pursue marketing and sales authorization in the other member states of the European Union.
VIVIMIND(TM) is a patented, amino acid, present in some species of algae, to support cognitive function and memory. VIVIMIND(TM) is now available in Canada. Recently published data in a peer-reviewed journal show that homotaurine slows the loss of volume in the hippocampus, a region of the brain associated with memory, and has a beneficial effect on cognition(1).
U.S. Regulatory Update
With respect to the United States, OVOS Natural Health Inc., a wholly owned subsidiary of BELLUS Health Inc., has filed a premarket notification of a New Dietary Ingredient for homotaurine with the U.S. Food and Drug Administration, and is pursuing mandatory associated regulatory activities to obtain marketing approval for homotaurine as a dietary supplement.
About BELLUS Health Inc.
BELLUS Health is a global health company focused on the development and commercialization of products to provide innovative health solutions to address critical unmet needs.
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For additional information on BELLUS Health and its drug development programs, please call the Canada and United States toll-free number 1-877-680-4500 or visit the Web Site at www.bellushealth.com.
(1) S. Gauthier, P. S. Aisen, S. H. Ferris, D. Saumier, A. Duong, D. Haine, et al. (2009). Effect of Tramiprosate in Patients with Mild-to-Moderate Alzheimer's Disease: Exploratory Analyses of the MRI Sub-group of the Alphase Study. Journal of Nutrition, Health and Aging, Volume 13, Number 6/June 2009, 550-557.
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