Shares of UK and Australian-listed MGC Pharmaceuticals skyrocketed on Tuesday after the pharmaceutical company announced its COVID treatment ArtemiC has been listed as an over-the-counter (OTC) drug in the United States.
The company said ArtemiC had been granted OTC, non-prescription drug status after being listed on the Food and Drug Administration (FDA) National Drug Code Database (NDC).
In turn, MGC’s US-based supply and distribution partner AMC Pharma USA has placed a US$2mln purchase order for ArtemiC, with production to commence immediately for delivery in two installments in the third quarter and fourth quarter this year.
“This certainly represents a significant step forward for the company, including bringing in US$2mln in revenue,” MGC chief commercial officer Robert Clements told Proactive.
“The US is the largest pharmaceutical market in the world, so it is excellent that ArtemiC has been listed with an NDC by the FDA,” Clements said.
“We are excited by the opportunities with our partner AMC as we are very heavily focussed on meeting unmet medical needs across all of our pipeline by developing novel and affordable products.”
Filling a gap in the market
The OTC listing for ArtemiC is indeed significant for the company as there are few FDA-approved COVID treatments currently available, with MGC’s offering set to fill a gap in the market.
As of March 14, the FDA has approved the antiviral drug Veklury (remdesivir) for adults and certain pediatric patients with COVID-19 and immune modulators Olumiant (baricitinib) and Actemra (tocilizumab) for certain hospitalized adults with COVID-19.
Additionally, two oral antiviral pills (Paxlovid and Lagevrio) have been authorised for emergency use for the treatment of certain patients with mild to moderate COVID-19.
“Through our partnership with MGC, we are now able to offer the market a clinically proven, plant-based, and FDA-authorised product that fills an important hole in the market between existing OTC products and expensive prescription products from Big Pharma,” commented AMC’s Brent W Yessin in a statement.
ArtemiC’s OTC status means it can be sold via the US-based Pharmacy Benefit Management (PBM) networks, including prescription discount services, from April 2023.
AMC is also negotiating with the largest pharmacy chains and independent retailers in the US to get the product on pharmacy shelves, with nationwide availability set to increase retail access and subsequent sales.
In terms of the company’s next steps, CCO Clements told Proactive: “We are continuing to progress and develop our clinical pipeline both in terms of our anti-inflammatory and our cannabinoid-based products. We will always bring these products to markets in a timely manner.”
About ArtemiC
MGC developed its clinically tested, all-natural COVID treatment ArtemiC with bioavailability technology from its partner Swiss PharmaCan AG.
During a Phase II trial involving 50 patients with COVID-19, ArtemiC demonstrated the ability to prevent the deterioration of patients and achieve faster clinical improvement; the ability to reduce symptoms and pain associated with COVID-19; and the opportunity to reduce pressure on the healthcare system with scope for both community and hospital applications.
Subsequent trials have shown ArtemiC to be an effective anti-inflammatory across a range of chronic diseases.
After its Australian-listed shares closed up 85% at A$0.0130 on Tuesday, MGC’s London-listed shares were up 48.2% at 0.6300p on Tuesday afternoon.
Contact the author at emily.jarvie@proactiveinvestors.com
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