MGC Pharma has secured its biggest order for any product with its US distributor AMC Holdings confident CimetrA may be the much-needed wonder drug to treat COVID-19.

Europe-based biotech MGC Pharma (ASX:MXC) has secured its largest ever order with 110,000 units of its COVID-19 treatment CimetrA from AMC Holdings, its distribution partner in the US.

Valued at US$3 million, it is the largest single order that MCG Pharma has received for any product to date and is only for AMC’s initial distribution within the US state of Florida.

The order is part of a three-year US$24 million US supply and purchase agreement announced with AMC Holdings in August, enabling MCG Pharma to access the world’s largest healthcare market.

The distribution agreement with AMC covers all three of MGC’s lead products of CannEpil, CogniCann and CimetrA.

MGC has secured a US$1m payment from AMC for the first order delivery of CimetrA with US$375k received and a US$625k letter of credit.

As part of the agreement AMC must provide a larger letter of credit for the US$2m balance of the full Year 1 purchase order value. That will be provided to MGC Pharma in the coming weeks, ahead of the first commercial supply of CimetrA.

The order represents a major step forward for the company as it starts to commercialise its clinically proven COVID-19 treatment globally.

AMC is in the process of securing regulatory approval for receiving CimetrA for distribution within the USA, which is expected to take about six weeks.


CimetrA a proven treatment in severe COVID-19

CimetrA is the pharmaceutical version of MGC’s nutraceutical branded product, ArtemiC, which is already being sold by Swiss PharmaCan in Europe.

The anti-inflammatory drug has been proven through clinical trials to help reduce the hyper-inflammatory response seen in some patients with severe COVID-19, known as cytokine storm.

Last month the drug was granted regulatory approval in Germany following  double-blinded placebo-controlled Phase II clinical trials showing ArtemiC statistically significantly improved the recovery of COVID-19 patients against a placebo group.

Indian authorities have also given MGC approval to import CimetrA into the COVID-19 ravaged country. The import green light was a crucial step to CimetrA being granted Emergency Use Authorisation as a medicine for treatment of COVID-19 patients in India.

CimetrA is now undergoing a Phase III clinical trial in Israel as an Investigational Medicinal Product for the treatment of COVID-19 following the successful Phase II trials. The first patient was enrolled at the Israel trial site in July 2021.

AMC is working with the University of South Florida in Tampa and the Holy Cross Hospital in Fort Lauderdale to submit CimetrA along with CogniCann to their respective Internal Review Boards (IRB) for approval, and initiation of clinical trials.

IRB approval will enable each facility to participate in ongoing clinical trials for CimetrA and  also be active clinical trial sites forCogniCann.


US a critical target market for MGC

MGC Pharma managing director and CEO, Roby Zomer, welcomed the first order from AMC, which specialises in bringing clinical-stage biotech products from around the world into the US market.

“The receipt of the first year US$3m purchase order for CimetrA from AMC firmly establishes our exciting partnership and MGC Pharma’s expansion into the USA market for our unique phytomedicines,” Zomer said.

“The agreement will provide a foundation for further clinical research and development of our products and enable access for US patients to have access to our products in the immediate future.”

AMC general counsel Brent Yessin said US healthcare workers need more tools to treat people before they are so sick they need oxygen, and political leaders want to give them what they need.

  “The average cost of COVID-19 hospital stays in the US is $40,000, meaning for every 1,000 patients you keep out of hospital, you save $40 million and countless lives,” he said.

MGC Pharma’s global footprint is continuing to expand, with the company listing on the UK’s premier stock market the London Stock Exchange (LSE) in February, while establishing clinical trials and distribution channels in key markets globally.

At the time of writing the MGC share price in Australia was up 3.45% to 6 cents.

This article was developed in collaboration with MCG 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.