MYOS Corporation Receives Health Canada Approval of Proprietary Ingredient Fortetropin(R)
First Fertilized Egg Powder Approved in Canada
CEDAR KNOLLS, NJ -- (Marketwired) -- 05/28/15 -- MYOS Corporation ("MYOS" or the "Company") (NASDAQ: MYOS), an emerging biotherapeutics and bionutrition company focused on the discovery, development and commercialization of products that improve human muscle health and performance, announced today that Health Canada, has reviewed and approved Fortetropin®, the Company's proprietary ingredient, for sale in powder dose form in Canada. Fortetropin is the first fertilized egg yolk powder ingredient to be approved by Health Canada and issued a Natural Product Number.
In order to support the incorporation of Fortetropin as a medicinal ingredient in finished products for sale in Canada, MYOS submitted evidence to the Natural and Non-prescription Health Products Directorate of Health Canada to substantiate the quality, safety and efficacy of Fortetropin. For more information about Fortetropin, a letter of access, explaining Fortetropin's claims and uses, is available upon request.
Maghsoud Dariani, head of Science and Technology for MYOS, commented, "Our investment in, and commitment to, Fortetropin runs deep. MYOS realized the potential of this ingredient in 2011, and invested a great deal of research into manufacturing, quality control and quality assurance. Fortetropin is a bioactive proteo-lipid complex made from fertilized chicken egg yolk using a proprietary process that retains the biological integrity and bioactivity of the mixture. Egg yolk is known as one of the most nutritionally dense natural foods available, making it a strong candidate for inclusion in medical and functional foods. MYOS is very excited to have the opportunity to sell Fortetropin powder in Canada."
Lindsey Penrose, MYOS' Vice President of Business Development, added, "We are very pleased that Fortetropin has been granted regulatory approval by Health Canada in a powder dose form. Canadian natural health product regulations are extremely strict and we believe this approval attests to Fortetropin's high level of safety and scientific support."
About MYOS Corporation
MYOS is an emerging biotherapeutics and bionutrition company focused on the discovery, development and commercialization of products that improve muscle health and function essential to the management of sarcopenia, cachexia and degenerative muscle diseases. MYOS is the owner of Fortetropin®, the first clinically proven natural myostatin inhibitor. Myostatin is a natural regulatory protein, which inhibits muscle growth and recovery. Medical literature suggests that lowering myostatin levels has many potential health benefits including increased muscle mass, healthy weight management, improved energy levels, stimulation of muscle healing as well as treating sarcopenia, a condition of age-related loss of muscle mass. To discover why MYOS is known as "The Muscle Company,"™ visit www.myoscorp.com
About Health Canada
The mission of Health Canada is to make Canada the healthiest country in the world. Relying on high quality research, Health Canada communicates information and encourages Canadians to take an active role in their health. All natural health products (NHPs) sold in Canada are subject to the Natural Health Products Regulations, which came into force on January 1, 2004. [The Regulations help give Canadians access to a wide range of natural health products that are safe, effective and of high quality. Through the Natural Health Products Directorate, Health Canada assures that all Canadians have ready access to a wide range of natural health products that are safe, effective and of high quality.](1)
The safety and efficacy of NHPs and their health claims must be supported by proper evidence so that consumers and Health Canada know the products are indeed safe and effective. Evidence may include clinical trial data or references to published studies, journals, pharmacopoeias and traditional resources. The type and amount of supporting evidence required depends on the proposed health claim of the product and its overall risks.
As part of the Health Products and Food Branch of Health Canada, the Natural and Non-prescription Health Products Directorate (NNHPD) is the regulating authority for natural health products for sale in Canada. Its role is to ensure that Canadians have ready access to natural health products that are safe, effective and of high quality while respecting freedom of choice and philosophical and cultural diversity.
The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) subsequent to its recently expanded mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs). Source: http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/nhpd-dpsn/index-eng.php
About Rē Muscle Health™
The Rē Muscle Health™ series is the Company's first branded line of muscle health products. This unique line of all-natural, non-GMO products contain Fortetropin®, an egg-based, all natural myostatin inhibitor clinically proven to build healthy muscle. The Rē Muscle Health™ series can be ordered by visiting www.remusclehealth.com. MYOS believes that Fortetropin®, as well as future products it envisions, will redefine existing standards for muscle health. The Rē Muscle Health™ product line is owned and sold directly by the Company at www.remusclehealth.com.
Any statements in this release that are not historical facts are forward-looking statements. Actual results may differ materially from those projected or implied in any forward-looking statements. Such statements involve risks and uncertainties, including but not limited to those relating to the successful continued research of Fortetropin® and its effects on myostatin inhibition, inflammatory cytokine levels and cholesterol levels, the successful launch and customer demand for our Rē Muscle Health™ and other products, the continued growth of repeat purchases, market acceptance of our existing and future products in countries outside of the United States (such as Canada), the ability to create new products through research and development, growth in our revenue, the successful entry into new markets including the age management market, the ability to collect our accounts receivable from our distributors, our ability to raise capital to fund continuing operations, the ability to attract additional investors and increase shareholder value, the ability to generate the forecasted revenue stream and cash flow from sales of Fortetropin® and Rē Muscle Health™, the ability to achieve a sustainable profitable business, the effect of economic conditions, the ability to protect our intellectual property rights, the ability to maintain and expand our manufacturing capabilities and reduce the costs of our products, the ability to comply with NASDAQ's continuing listing standards, competition from other providers and products, risks in product development, and other factors discussed from time to time in our Securities and Exchange Commission filings. We undertake no obligation to update or revise any forward-looking statement for events or circumstances after the date on which such statement is made except as required by law.
These statements have not been evaluated by the Food and Drug Administration. Our products are not intended to diagnose, treat, cure or prevent any disease.
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Source: MYOS Corporation
Released May 28, 2015