ECUBLENS, SWITZERLAND, July 16 /PRNewswire-FirstCall/ - BELLUS Health (International) Limited, a wholly owned subsidiary of BELLUS Health Inc. (BELLUS Health, TSX: BLU), 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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(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.
Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond BELLUS Health Inc.'s control. Such risks include but are not limited to: the impact of general economic conditions, general conditions in the pharmaceutical and/or nutraceutical industry, changes in the regulatory environment in the jurisdictions in which the BELLUS Health Group does business, stock market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation, that actual results may vary once the final and quality-controlled verification of data and analyses has been completed, as well as other risks disclosed in public filings of BELLUS Health Inc. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. The reader should not place undue reliance, if any, on any forward-looking statements included in this news release. These statements speak only as of the date made and BELLUS Health Inc. is under no obligation and disavows any intention to update or revise such statements as a result of any event, circumstances or otherwise, unless required by applicable legislation or regulation. Please see the Annual Information Form of BELLUS Health Inc. for further risk factors that might affect the BELLUS Health Group and its business.
CONTACT: Michelle Stein, Specialist, Corporate Communications, (450) 680-4573, email@example.com
|SOURCE BELLUS HEALTH INC.|
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