The ball is now rolling for medicinal cannabis company MGC Pharma (ASX: MXC) for their entry into the United States, having received their first orders from AMC Holdings as part of plans to fast-track regulatory approval for phytocannabinoid-derived medicines in the US.
The order is for 1000 units of CimetrA™ which are manufactured at MGC’s facility in Slovenia and is part of the 3-year supply and distribution agreement signed between MGC and AMC last month. The deal was underpinned by minimum orders of USD $24 million (approx AUD $33.4m) of MGC phytomedicine products including CannEpil®, CogniCann® and CimetrA™.
This first order, however, is just part of the regulatory approvals process that MGC’s products must go through in the United States before AMC can commence commercial distribution.
Unlike the other cannabis-based products under the supply agreement with AMC, CimetrA™ is an anti-inflammatory treatment for patients diagnosed with COVID-19. It is consumed as an oral spray and contains Artemisinin, Curcumin, and Boswellia serrata.
“AMC are already making significant progress in propelling CimetrA™, CannEpil® and CogniCann® to Clinical Trial stage in the US and we are pleased that they have cemented relationships with these prestigious institutions for the continued research into our products,” said MGC Pharma CEO, Roby Zomer.
AMC is currently working with the University of South Florida in Tampa and the Holy Cross Hospital in Fort Lauderdale as part of the approvals process for CimetrA™. This first step will be to validate the order to make comparisons between the product from data collected at the lab in Slovenia, and that collected from US labs. This will then be followed by submissions for CimetrA™ to the Internal Review Board (IRB) for approval to commence Clinical Trials in the US.
Similar Clinical Trials are already approved and underway in Israel and India which will add to the data validity requirements from US regulators.
According to MGC Pharma, none of the patients in those Clinical Trial treatment group required additional oxygen, mechanical ventilation or admission to intensive care.
“As the US endures a COVID spike, keeping COVID positive patients out of the hospital has become a major policy objective of countless state Governors and their health departments,” said Brent Yessin, General Counsel for AMC.
“For every 1000 patients who are treated effectively and kept out of hospital, the state or healthcare systems save US$40M, a rare instance where clinical and financial imperatives are perfectly harmonized.”
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