The inclusion of MGC Pharma’s ArtemiC into the FDA’s NDC database will fill an important hole in the market between existing OTC products and expensive Big Pharma drugs.

European based MGC Pharma (ASX:MXC) is set to expand its addressable market in the US after ArtemiC was listed as an over-the-counter (OTC) status on the FDA’s National Drug Code Database (NDC).

The OTC status means that ArtemiC, MGC’s proprietary clinically tested COVID-19 treatment, could now be sold through the US Pharmacy Benefit Management (PBM) networks starting in April.

The successful NDC listing was facilitated by MGC’s supply and distribution partner, AMC Pharma.

AMC is a Special Purpose Vehicle founded by experienced US healthcare professionals and former federal US government officials to promote the research and growth of phyto-medicines in the US.

Now that the NDC has been listed, AMC is wasting no time negotiating shelf space for ArtemiC with some of the largest US Pharmacy networks and independent pharmacies.

In addition, AMC has submitted a purchase order for US$2 million of ArtemiC with MGC for immediate production and delivery in two installments over Q3 and Q4 of this year.

“The listing of ArtemiC as an OTC drug provides significant access to the largest healthcare market in the world, and stands as a major milestone MGC’s growth progression,” said MGC Pharma CEO, Roby Zomer.

“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.”

ArtemiC’s efficacy and safety

ArtemiC is a non-cannabis, all-natural medical spray developed by MGC Pharma – utilising Swiss Pharmacan’s MyCell and GraftBio’s SNEDD technology that have been proven to increase the bioavailability of the natural ingredients used in ArtemiC’s formulation.

The phyto-medicine formulation used in ArtemiC includes four naturally-based ingredients consisting of curcumin, boswellia serrata, artemisinin and Vitamin C.

In a Phase-2 double-blind, placebo-controlled Clinical Trial on 50 patients with COVID-19, ArtemiC has demonstrated a full safety and efficacy profile with no drug-adverse events.

The study concluded that ArtemiC has the ability to prevent deterioration of COVID-19 patients and achieve faster clinical improvement, reducing pressure off the healthcare system.

Subsequent trials have also proven ArtemiC to be an effective anti-inflammatory across a wide range of chronic diseases.

Filling a market gap

Today’s inclusion of ArtemiC into the FDA’s NDC database means that US patients are able to buy the product through the Pharmacy Benefit Management (PBM) network.

The PBM network has many benefits including cheaper costs, which help lower overall healthcare costs for consumers and payers. The PBM also ensures that medications are chosen based on their safety, effectiveness, and value.

Meanwhile, the NDC database provides a standardised format for drug information, which makes it easier for healthcare providers to compare different drugs, and helps prevent medication errors.

Brent Yessin of AMC believes that securing NDC inclusion for ArtemiC will result in 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 authorised product that fills an important hole in the market between existing OTC products and expensive prescription products from Big Pharma,” Yessin said.

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

This article was developed in collaboration with MGC Pharma, a Stockhead advertiser at the time of publishing.

 This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.