MXC.L Regulatory News (MXC)

ArtemiC™ Listed as an OTC Drug in the USA; AMC Places US$2m order

21 March 2023

ASX,LSE: MXC

Highlights:

· ArtemiC™ has now been listed as an over-the-counter, non-prescription drug status in the USA, following the listing on the FDA National Drug Code Database (NDC), facilitated by MGC Pharma's US-based supply and distribution partner, AMC Pharma USA, LLC. (AMC)

· ArtemiC™ is to be sold at US Pharmacy Benefit Management (PBM) networks from April 2023, with other independent outlets still in talks with AMC

· Following the NDC Listing, AMC have placed a purchase order for ArtemiC™ to the value of US$2,000,000

· AMC Holdings, Inc. is a 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, and sees MGC Pharma as a leader in the sector for the domestic market

· ArtemiC™ Phase II Clinical Trial undertaken in 2020[1], demonstrated a range of benefits for patients suffering from moderate COVID-19. Subsequent trials have proven ArtemiC™ to be an effective anti-inflammatory across a wide range of chronic diseases

MGC Pharmaceuticals Ltd ('MGC Pharma' or 'the Company') a European based pharmaceutical company specialising in the production and development of plant inspired medicines, is pleased to report that ArtemiC™ , MGC's proprietary clinically tested for COVID 19 treatment, has been listed as over-the-counter (OTC) status on the National Drug Code Database (NDC) of the US Food and Drug Administration (FDA), as facilitated by MGC supply and distribution partner, AMC Pharma, LLC.

This OTC status means that AMC will be able to sell ArtemiC™ via US-based Pharmacy Benefit Management (PBM) networks, including prescription discount services, from April 2023. AMC are negotiating with the largest US Pharmacy networks, and independent pharmacies for the inclusion of ArtemiC™ in shelf space now that the NDC has been listed. This nation-wide availability across the country will increase retail access and subsequent sales.

Further to this, AMC have submitted a purchase order for US$2m of ArtemiC™, with production to commence immediately, for delivery in two instalments in Q3 and Q4 of this year.

 ArtemiC™ can be found on the FDA National Drug Code Directory under the code: 83278.

Brent W. Yessin of AMC, commented: "AMC are pleased to have been able to assist in securing the NDC for MGC Pharma's proprietary product, ArtemiC™, which we believe will have considerable impact in the over-the-counter retail sector. Through our partnership with MGC, we are now able to offer the market a clinically proven, plant-based, and FDA authorized product that fills an important hole in the market between existing OTC products and expensive prescription products from Big Pharma."

Roby Zomer, CEO and Managing Director of MGC Pharmaceuticals, commented: "The listing of ArtemiC™ as over-the-counter drug, provides significant access to the largest healthcare market in the world and stands as a major milestone MGC's growth progression."

"The receipt of an order to the value of US$2m from our distribution partner, AMC, is a serious endorsement for the product, which has a demonstrated capacity to relieve symptoms of COVID-19 and other inflammatory diseases."

About ArtemiC™

ArtemiC™ is a clinically tested all natural product. Developed by MGC Pharma, incorporates partner Swiss PharmaCan AG and GraftBio® SNEDD technology, which increases the bioavailability of ArtemiC™'s active ingredients at cell level.

In a Phase II double-blind, placebo-controlled Clinical Trial on 50 patients with COVID-19, ArtemiC™ 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.

-Ends-

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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 with MGC Pharma as announced in August 2021, and amended to incorporate a US$1m purchase order of ArtemiC™ Rescue in August 2022.

About MGC Pharma

MGC Pharmaceuticals Ltd (LSE: MXC, ASX: MXC) is a European based pharmaceutical company, focused on developing and supplying accessible and ethically produced plant inspired medicines, combining in-house research with innovative technologies, with the goal of finding or producing treatments to for unmet medical conditions.

The Company's founders and executives are key figures in the global pharmaceuticals industry and the core business strategy is to develop and supply high quality plant inspired medicines for the growing demand in the medical markets in Europe, North America and Australasia.

MGC Pharma has a robust development pipeline targeting two widespread medical conditions and has further products under development. 

MGC Pharma has partnered with renowned institutions and academia to optimise the development of targeted plant inspired medicines, to be produced in the Company's EU-GMP Certified manufacturing facilities. 

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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