Application to Health Canada for ArtemiC Approval
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28 April 2021 ASX Code: MXC LSE Code: MXC |
MGC Pharmaceuticals Ltd MGC Pharma's North American distribution partner submits application to Health Canada for ArtemiC™ |
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MGC Pharmaceuticals Ltd (ASX, LSE: MXC, 'MGC Pharma' or 'the Company'), a European based bio-pharma company specialising in the production and development of phytocannabinoid-derived medicines, is pleased to advise that Glow LifeTech ( Glow, CSE: GLOW ), the Canadian-based development and North American distribution partner of MGC Pharma's ArtemiC™, has submitted an application to Health Canada to obtain product licenses for ArtemiC™ as a Natural Health Product (NHP), per its CSE announcement on 27 April 2021.
As announced on 15 December 2020, MGC Pharma released the results of a successful Phase II double-blind, placebo-controlled clinical trial, which showed ArtemiC™ statistically significantly improved the clinical recovery of COVID-19 patients in comparison with the Placebo Group. 100% of the patients in the treatment group met the trial's primary endpoint and fully recovered within 15 days. None of the patients supported by ArtemiC™ required additional oxygen, mechanical ventilation or intensive care, compared to 23.4% in the placebo group requiring further assistance. The results deliver a full safety and efficacy profile, which is further supported by additional testing for toxicity and mechanism of action.
"The global demand for natural, science-backed health products has been driven to new highs during this pandemic and Health Canada approved products are globally recognized as safe, effective and of high quality," said Rob Carducci, Chief Commercial Officer, Glow LifeTech. "ArtemiC™ is supported with COVID-19 clinical results and represents a significant opportunity for Glow as a natural, safe and effective product that can be made widely accessible during these challenging times."
ArtemiC™ was submitted to Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD) on March 11, 2021. The application, which is currently under review by Health Canada, included ArtemiC™ supporting COVID-19 Phase II clinical trial results. Under Canadian regulations, all NHPs must obtain premarket approval by Health Canada to assure they are safe, effective and of high quality before being allowed to be sold in Canada. Once Health Canada makes this assessment, they are issued a National Product Number (NPN).
"Glow is on a mission to unlock the healing power of plants and ArtemiC™ demonstrates the impact our unique technology can deliver. Our MyCellTM delivery technology provides us a platform to develop a broad portfolio of scientifically validated natural ingredients to power the next-generation of natural health products," said Tom Glawdel, PhD, Chief Operating Officer, Glow LifeTech.
Glow has exclusive rights to market, sell and distribute ArtemiC™ in Canada, U.S., Mexico and all Caribbean countries as a food supplement (nutraceutical, dietary supplement, natural health product).
ArtemiC™ is a clinically tested oral spray containing four natural active ingredients: Artemisinin, Curcumin, Boswellia serrata, and Vitamin C. The formulation uses the MyCell™ delivery system technology to increase bioavailability and effectiveness of natural active ingredients. ArtemiC™ was a collaborative development effort between MGC Pharma, Swiss PharmaCan AG and Glow, and is manufactured by MGC Pharma.
Roby Zomer, CEO of MGC Pharma , said: "The submission of this application to Health Canada by Glow is an important and exciting step in the classification of ArtemiC™ as a Natural Health Product. Broadening the accessibility for the treatment for symptoms of COVID-19 and will help more people suffering with the symptoms of the disease. Approval of Glow's application if granted will further highlight the robustness and effectiveness of our clinical trial processes in relation to treatments that we are able to develop and bring to market."
--Ends--
Authorised for release by the Board, for further information please contact:
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MGC Pharmaceuticals Ltd Roby Zomer CEO & Managing Director +61 8 6382 3390 |
UK PR Tavistock - Tavistock Charlies Vivian +44 20 7920 3150 Charles.Vivian@tavistock.co.uk Tim Pearson +44 7983118 502 |
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UK Broker - Turner Pope Andy Thacker Zoe Alexander +44 20 3657 0050 |
Australian PR/IR Advisors - Media & Capital Partners Rod Hinchcliffe (IR) +61 412 277 377 |
About MGC Pharma
MGC Pharmaceuticals Ltd (LSE: MXC, ASX: MXC) is a European based bio-pharma company developing and supplying affordable standardised phytocannabinoid derived medicines to patients globally. The Company's founders were key figures in the global medical cannabis industry and the core business strategy is to develop and supply high quality phytocannabinoid derived medicines for the growing demand in the medical markets in Europe, North America and Australasia. MGC Pharma has a robust product offering targeting two widespread medical conditions - epilepsy and dementia - and has further products in the development pipeline.
Employing its 'Nature to Medicine' strategy, MGC Pharma has partnered with renowned institutions and academia to optimise cultivation and the development of targeted phytocannabinoid derived medicines products prior to production in the Company's EU-GMP Certified manufacturing facility.
MGC Pharma has a number of research collaborations with world renowned academic institutions, and including recent research highlighting the positive impact of using specific phytocannabinoid formulations developed by MGC Pharma in the treatment of glioblastoma, the most aggressive and so far therapeutically resistant primary brain tumour.
MGC Pharma has a growing patient base in Australia, the UK, Brazil and Ireland and has a global distribution footprint via an extensive network of commercial partners meaning that it is poised to supply the global market.
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About Glow LifeTech Ltd .
Glow LifeTech is a Canadian-based biotechnology company focused on producing nutraceutical and cannabinoid-based products with dramatically enhanced bioavailability, absorption, and effectiveness. Glow has rights to the ground-breaking, plant-based MyCell Technology® delivery system, which transforms poorly absorbed natural compounds into enhanced water-compatible concentrates that unlock the full healing potential of the valuable compounds.
Website: www.glowlifetech.com
About Swiss PharmaCan AG/Micelle Technology AG
Micelle Technology AG, parent company of Swiss PharmaCan is a dynamic organization dedicated to R&D using natural active ingredients (i.e. vitamins and minerals) to improve human health. As one of the leading innovators of plant-based micelle concentrates, Micelle Technology AG offers a unique technology, which enables the company to harness the full potential of herbal active ingredients.
Website: www.swisspharmacan.ch
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