The initial order in the US is expected to fast track the regulatory approval for CimetrA, and establish clinical trials for MGC Pharma’s other drugs, CogniCann and CannEpil.

Europe-based biotech MGC Pharma (ASX:MXC) has made crucial progress in its effort to fast track the sale of CimetrA in the US.

The company has just received an initial order for 1,000 CimetrA units on an expedited basis from AMC Holdings, its distribution partner in the US.

The units will be shipped to a pharmacy in the Tampa Bay area, where they will be analysed and held for research and regulatory purposes.

This marks the first step toward the first year commercial order of US$3m from AMC, as stipulated under the supply agreement deal between the two companies in August.

Under that deal, AMC is obliged to make minimum purchase orders of US$24m worth of MGC products over a three-year period.

The agreement also requires AMC to not only obtain regulatory approval for CimetrA, but also to establish clinical trials for both MXC’s other drugs CannEpil and CogniCann.

To fulfil this agreement, AMC is currently working with both the University of South Florida (UFS) in Tampa, and the Holy Cross Hospital in Fort Lauderdale, to submit CimetrA, and shortly thereafter CogniCann, to their respective Internal Review Boards (IRB) for approval.

The approval from these boards is the first step for both facilities to join the clinical trials which are underway in Israel, and to launch US-based clinical trials for CimetrA and CogniCann.

“AMC are already making significant progress in propelling CimetrA, CannEpil and CogniCann to clinical trial stage in the US, and we’re pleased that they have cemented relationships with these prestigious institutions for the continued research into our products,” commented MGC Pharma CEO, Roby Zomer.

 

Path to commercialisation

Shares in MGC rose more than 5% in morning trade, following today’s announcement.

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

MGC Pharma says that CimetrA (and also ArtemiC) is anti-inflammatory, and has been proven to reduce the hyper-inflammatory response seen in some COVID-19 patients, known as “cytokine storm”.

The drug is in late clinical development, and seeing active business development as a potential early-use product in a number of countries – with the US and India being the first two to sign up.

In early September, MGC Pharma was given the green light by the Indian government to import CimetrA,  as the company grapples with rising COVID-19 cases.

Leading Indian pharmaceutical manufacturer Medopharm has been appointed by MXC  to import and market CimetrA in India.

In the US, MXC’s partner AMC is also seeking to commercialise CimetrA as quickly as possible.

Brent Yessin, General Counsel for AMC said: “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.”

“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.”

Meanwhile, MXC’s CogniCann is a cannabinoid spray formulation product that uses a mixture of THC and CBD.

With CogniCann, MGC Pharma is trying to develop a new market in the relief of dementia symptoms such as in Alzheimer’s disease (AD).

Its other product, CannEpil, addresses epilepsy which is a prevalent condition affecting around five in a thousand people globally.

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.

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