MXC.L Regulatory News (MXC)

MGC Pharmaceuticals Ltd.

Import approval granted for ArtemiC™ Rescue in India, opening the Indian market for sales

6th January 2022

ASX, LSE: MXC

Key Highlights:

· Indian Regulators approve ArtemiC™ Rescue for import, distribution, marketing, and sales, and is now fully authorised and available for sale across India.

· MGC Pharma has completed a small batch import of ArtemiC™ Rescue into India as proof of concept with its local partner.

· ArtemiCTM Rescue is a nutraceutical which, in a Phase II Clinical Trial undertaken in 2020, demonstrated a range of benefits for patients suffering from moderate COVID-19.

MGC Pharmaceuticals Ltd ('MGC Pharma' or 'the Company') a European based bio-pharma company specialising in the production and development of phytomedicines, is pleased to announce that it has received an import approval permit for the importation of ArtemiC™ Rescue into India. ArtemiCTM Rescue is MGC Pharma's proprietary nutraceutical, and part of its ArtemiCTM range of products which has been proven in a Phase II Clinical Trial to help alleviate symptoms associated with COVID-19.[1]

The nutraceutical, developed by MGC Pharma and incorporating distribution partner, Swiss PharmaCan AG's ('SPC'), award winning MyCellTM technology, has undergone a small batch trial import, and has passed all required regulatory motions to enable the sale of the product in India, with the grant of a Food Safety and Standards Authority of India license. Additionally, it has passed the Indian Customs' import requirements, resulting in the approval for the sale of ArtemiC™ Rescue across India.

This approval will further expand the global footprint for the sale and distribution of ArtemiC™ Rescue. MGC Pharma received approval for the import permit of ArtemiC™ Rescue with the assistance of a local partner, Carino Water Solutions & Energy ('Carino'). With India's population of ~1.38 billion, and soaring COVID-19 infections, the receipt of these approvals is a major step forward in the development of global markets for the sale of ArtemiC™ Rescue.

MGC Pharma, SPC, and Carino will be continuing to seek approvals for ArtemiC™ Rescue as a nutraceutical in a number of countries in order to provide support to COVID-19 patients in the alleviation of their symptoms. In conjunction with this, MGC Pharma is making progress on the long-term development of its Investigational Medicinal Product, CimetrA™, through ongoing clinical studies and applications for Emergency Use Authorisation in India, and other National Regulatory and Medical Agencies currently underway, including seeking FDA approval in the United States.

CimetrA™ Emergency Use Authorisation in India Update

In September 2021, MGC Pharma announced that it was seeking Emergency Use Authorisation in India for CimetrA™ for the treatment of patients with COVID‐19. This process is ongoing, with a further patient study required to be conducted in India to confirm the efficacy of the product for local patients currently underway.

About ArtemiCTM Rescue

ArtemiC™ Rescue is a clinically tested food supplement (nutraceutical, dietary supplement, natural health product) containing four natural based ingredients consisting of Artemisinin, Curcumin, Boswellia serrata, and Vitamin C.

In a Phase II double-blind, placebo-controlled Clinical Trial on 50 patients with COVID-19, ArtemiCTM Rescue demonstrated the following advantages:

· A full safety and efficacy profile with no drug-adverse events

· The ability to prevent deterioration of COVID-19 patients and achieve faster clinical improvement

· The ability to assist in reducing the pressure on the medical system and support coping with hospitalised patients

· The ability to reduce symptoms and pain associated with COVID-19

· The versatility to be used in community as well as in hospitals

(refer ASX announcement on 15 December 2020, titled "ArtemiCTM Phase II Clinical Trial Results on COVID-19 patients confirm 100% of treatment group successfully met primary and secondary endpoints")

Roby Zomer, co-founder and Managing Director of MGC Pharma, commented: "We are proud of achieving the milestone of being granted Indian import and distribution approval for of ArtemiC™ Rescue, and are pleased to have the opportunity to alleviate the symptoms of COVID-19 in one of the largest populated countries in the world.

Whilst the virus continues to mutate, as we have seen with Omicron, MGC Pharma is well placed to offer a solution on a worldwide scale to ease the pressure on national healthcare systems and aid the economic recovery of jurisdictions who have been widely affected by the pandemic."

Nilesh Mehta, Director of Carino Water Solutions & Energy

"We are pleased to help the efforts of such a valuable solution to the devastating effects of COVID-19. We look forward to providing more assistance in preventing the damaging effects caused by COVID-19 in India.

Michel Fässler, CEO of Swiss PharmaCan.

"Opening up the Indian market to enable ArtemiC™ Rescue to be sold and distributed is a key milestone for all of us. We are proud at Swiss PharmaCan to continue developing the sales pipeline with MGC Pharma with our award-winning MyCellTM Technology."

--Ends--

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About MGC Pharma

MGC Pharmaceuticals Ltd (LSE: MXC, ASX: MXC) is a European based bio-pharma company developing and supplying affordable standardised phytomedicines 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 Swiss PharmaCan AG

Micelle Technology AG, parent company of Swiss PharmaCan AG 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