MXC.L Regulatory News (MXC)

MGC Pharmaceuticals Ltd.

AMC Holdings, Inc. places US$1M ArtemiC™ Rescue order

17 August 2022

ASX, LSE: MXC

Key Highlights:

· Updated US Supply and Distribution Agreement signed with USA strategic partner AMC Holdings, Inc. (AMC) to include MGC Pharma proprietary product, ArtemiC™ Rescue.

· AMC has submitted a purchase order for ~US$1,000,000 of ArtemiC™ Rescue, with production to commence immediately, and delivered into the USA for AMC customers over the next 3 months.

· 3,500 units of ArtemiC™ Rescue have already been delivered to AMC in the USA, clearing the regulatory requirements for US import of the product, and resulting in the US$1,000,000 purchase order.

· AMC is Special Purpose Vehicle founded by experienced US healthcare professionals and former federal US government officials to facilitate the research and growth of Phyto-medicines in the USA, which sees MGC Pharma as a leader in the sector for the domestic market.

· 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 a new ~US$1,000,000 order for its clinically proven anti-inflammatory product, ArtemiC™, under an updated US Supply and Distribution Agreement signed with AMC Holdings, Inc. (AMC).

The production of ArtemiC™ Rescue will begin immediately and is to be delivered to AMC over the next three months. 3,500 units of ArtemiC™ Rescue units have recently been delivered to AMC, clearing all necessary regulatory requirements for its import to USA, resulting in the placing of a new US$1,000,000 purchase order by AMC.

The US Supply and Distribution Agreement executed with AMC in August 2021, and which originally covered MGC Pharma's CimetrA™, CogniCann®, and CannEpil® products, has been recently amended to include ArtemiC™ as a result of ongoing commercial market evaluation in the USA by AMC on the Company's product line. The developing strategic relationship with AMC in respect to the commercial and research opportunities in the USA market has delivered this new commercial opportunity, which commences with the new ~US$1M ArtemiC™ order, and which may lead to additional purchase orders based on future demand from AMC's US distribution channels.

MGC Pharma and AMC are also currently advancing work on the potential opportunity, and regulatory approvals, to bring MGC Pharma's leading phyto-cannabinoid medicines, CogniCann® and CannEpil® into the USA under existing early patient access schemes.

MGC Pharma Managing Director and CEO, Roby Zomer commented: "The inclusion of ArtemiC™ in the AMC Supply and Distribution agreement recognises the progress that MGC Pharma has made in the development of this product, and the receipt of AMC's initial ~US$1M order is a great step for the Company as it further expands its reach into the global market for a product which has demonstrated great potential from clinical trial data to date.

"MGC Pharma is excited to be at the forefront of phytomedicinal research, and the opportunity to enter the world's largest, and most advanced Healthcare market, and we look forward to the insight that AMC will bring to the future clinical development of ArtemiC™."

About ArtemiC™

ArtemiC™ is a clinically tested food supplement (nutraceutical, dietary supplement, natural health product) containing natural based ingredients. The nutraceutical, developed by MGC Pharma, incorporates Swiss PharmaCan AG's MyCellTM technology, which increases the bioavailability of ArtemiCTM's active ingredients at cell level.

In a Phase II double-blind, placebo-controlled Clinical Trial on 50 patients with COVID-19, ArtemiCTM 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 healthcare system and associated support, coping with hospitalised patients.

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

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

About AMC Holdings, Inc.

AMC is a privately owned US based distribution and marketing company which seeks to bring cutting edge bio-pharmaceutical products currently in clinical trials, or in commercial production overseas, into the US healthcare marketplace. AMC was founded by experienced US healthcare professionals and former federal government officials to arrange for leading US researchers, academic institutions, and physicians to join existing clinical trials abroad, and establish clinical trials for promising bio-pharmaceutical products that meet three key criteria:

· Address disease management for pressing healthcare needs that have proven intractable and expensive with existing treatments or protocols;

· Offer botanical or bio-pharmaceutical solutions where none exist, or as alternatives to existing medications with negative side effects affecting patients' quality of life; and

· Offer the prospect of expanding access to novel treatments with lower cost alternatives to existing drugs or protocols.

MGC Pharma's products all meet the criteria, and their efficacy has been demonstrated through the clinical trial process, which has paved the way for the original Sales and Distribution Agreement, and the subsequent amendment.

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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. 

About AMC Holdings, Inc.

AMC Holdings, Inc. is a new company with expertise in healthcare and vast experience within US governmental bodies, who see Botanical and Natural Medicines as an area of huge growth potential in the US and see MGC Pharma as a global leader in the sector.

AMC is led by CEO, Brett Scott, who spent 20 years working within the US government including the Department of Justice and US Senate. General Counsel Brent Yessin has extensive links with the healthcare industry, representing some of the largest healthcare providers and investors over the course of his time in practice. Associate General Counsel, Jim Cusack was a Partner at law firm Fowler White, and former special agent at the FBI. He was recognised by the US Drug Enforcement Agency with its Lifetime Achievement Award in 2012.

AMC's widespread networks in US government agencies and institutions as well as the Board of Directors' collective knowledge of the healthcare sector, will enable MGC Pharma products to be effectively distributed and marketed in the USA, and to find a location for the first clinical trials of MGC products in the USA.

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