The US$750k received today is just the first part of the US$24m three-year agreement with US distributor, AMC Holdings.

European-based biotech MGC Pharma (ASX:MXC) has received the full US$750k cash deposit from its US distributor AMC Holdings, validating the partnership to supply MGC Pharma products into the largest market in the world.

The supply agreement was originally inked with AMC Holdings in August, and obliges AMC to make minimum purchase orders of US$24m worth of MGC products over a three-year period.

Under that deal, the first US$3m is to be paid in advance upon initial orders received within the first year.

These initial payments were triggered following the first order received in October from AMC, where 1,000 CimetrA units were purchased.

US$750k of that has been received today in cash,  with the remaining US$2.25m to be covered by either cash or an irrevocable Letter of Credit acceptable to MGC Pharma, upon delivery of the first CimetrA shipment to the US.

“The receipt of the full US$750,000 cash deposit from AMC Holdings is further validation of our future partnership to supply MGC Pharma products into the largest market in the world,” said Roby Zomer, CEO of MGC Pharma.

In addition, AMC is currently working towards submission of MGC Pharma products to the University of South Florida’s Internal Review Board for approval.

This represents the first step towards the University joining the international clinical trials for CimetrA.

“This is an exciting partnership in the US, with a highly credentialed group, for MGC Pharma and its investors, as we look to take CimetrA through the regulatory approval processes in both the USA and India, two of the largest pharmaceutical markets in the world.”


Path to commercialisation

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.

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

“We believe CimetrA has the ability to be a gamechanger for the treatment of COVID-19 globally, and look forward to providing CimetrA to patients, at an affordable price,” said Zomer.

AMC’s general counsel, Brent Yessin, has confirmed his company had retained Morgan Lewis & Bockius, a leading US law firm to seek FDA approval for CimetrA.

Yessin said that for every 1000 patients who are treated effectively and kept out of hospital, the state or healthcare systems save US$40m.

“Public and private healthcare providers want access to a natural product that proved effective in Israeli and international trials,” he said.

This week, Dr Bill Massey, a well-known neuro-pharmacologist, formerly with AstraZeneca, will commence work with MGC to help get CimetrA into the hands of US based doctors and patients as soon as possible.

Dr Massey has guided numerous drugs through the FDA process, and  has now joined the AMC team.

“We have also built a product approval team around one of the best FDA attorneys in the US, Kathy Sanzo,” Yessin said. “We have also hired experienced DC based regulatory affairs firms to assist in this process.”

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.