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

Rhea-AI Summary

MGC Pharmaceuticals Ltd. (LSE: MXC, OTC: MGCLF) announced that its product ArtemiC™ is now listed as an OTC drug in the US, according to the FDA National Drug Code (NDC) Database. This milestone, facilitated by US partner AMCPharma USA, allows ArtemiC™ to enter US Pharmacy Benefit Management (PBM) networks by April 2023. AMC has placed a US$2 million order, with deliveries scheduled for Q3 and Q4 2023. ArtemiC™, which has shown effectiveness in treating moderate COVID-19 and chronic inflammatory diseases, was developed with Grat Bio® SNEDD technology, ensuring high bioavailability and safety.

Positive

• Listing of ArtemiC™ as an OTC drug opens access to the US market.
• US$2 million purchase order from AMC indicates strong market interest.
• Successful Phase II Clinical Trial results boost product credibility.
• Product demonstrates capacity to treat moderate COVID-19 and chronic inflammatory diseases.

Negative

• None.

Innovative Plant-Based Medicine Set to Transform Inflammatory Disease Treatments in the US Market

LONDON, March 22, 2023 /PRNewswire/ -- MGC Pharmaceuticals Ltd. (LSE: MXC), (ASX: MXC), (OTC: MGCLF), a European based bio-pharma company specializing in the development and supply of affordable, ethically produced plant-inspired medicines, announces that its innovative product ArtemiC™ has recently been listed as an over-the-counter (OTC) drug in the USA on the FDA National Drug Code (NDC) Database under the code 83278. Facilitated by the company's US-based supply and distribution partner, AMCPharma USA, LLC. (AMC), ArtemiC™ will be available in US Pharmacy Benefit Management (PBM) networks starting April 2023, with ongoing discussions for its inclusion in other independent outlets.

In response to the NDC listing, AMC has placed a US$2 million purchase order for ArtemiC™, with production set to commence immediately. Delivery is scheduled in two installments in Q3 and Q4 of this year. ArtemiC™, which completed a successful Phase II Clinical Trial in 2020, has demonstrated significant benefits for patients suffering from moderate COVID-19. Subsequent trials have proven its effectiveness as an anti-inflammatory treatment across a wide range of chronic diseases.

Brent W. Yessin of AMC expressed his enthusiasm, "We are pleased to have secured the NDC for MGC Pharma's proprietary product, ArtemiC™, which we believe will make a considerable impact in the over-the-counter retail sector. Our partnership with MGC enables us to offer the market a clinically proven, plant-based, FDA-authorized product that fills an important gap between existing OTC products and expensive prescription products from Big Pharma."

Roby Zomer, CEO and Managing Director of MGC Pharmaceuticals, added, "The listing of ArtemiC™ as an over-the-counter drug provides significant access to the largest healthcare market in the world and stands as a major milestone in MGC's growth progression. The receipt of a US$2 million order from our distribution partner, AMC, is a strong endorsement for the product, which has demonstrated the capacity to relieve symptoms of COVID-19 and other inflammatory diseases."

ArtemiC™, an all-natural product developed by MGC Pharma in collaboration with partner Swiss PharmaCan AG and Grat Bio® SNEDD technology, increases the bioavailability of its active ingredients at the cellular level. The versatile treatment has shown a full safety and efficacy profile with no drug-adverse events and can be used in community settings and hospitals alike.

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SOURCE MGC Pharmaceuticals Ltd

FAQ

What does the OTC listing of ArtemiC™ mean for MGC Pharmaceuticals?

The OTC listing allows ArtemiC™ to be sold in the US, increasing its market reach and accessibility.

When will ArtemiC™ be available in US pharmacies?

ArtemiC™ is expected to be available in US Pharmacy Benefit Management networks starting in April 2023.

What is the significance of the US$2 million order for ArtemiC™?

This order from AMCPharma USA signifies strong demand for ArtemiC™ and supports its market entry.

What are the benefits of ArtemiC™?

ArtemiC™ has shown effectiveness in treating symptoms of COVID-19 and various chronic inflammatory diseases.

How does ArtemiC™ ensure safety and efficacy?

ArtemiC™ has completed successful clinical trials and is developed using technology that enhances its bioavailability without adverse effects.