The supply and distribution deal signed today marks the first step towards bringing MGC Pharma’s products to US patients.

European-based biopharma company MGC Pharma (ASX:MXC) has made a crucial step into the US market, after signing an agreement to supply the company’s pharmaceutical products to the country.

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

This covers all three MGC’s lead products of CannEpil, CogniCann and CimetrA.

The deal is the first dedicated agreement executed by MGC in the US, giving the company access to the largest healthcare market in the world.

The agreement is also an important step in expediting the clinical trials process for both CannEpil and CogniCann, as AMC will be required to recruit patients for those trials as part of the deal.

As a licensed distributor, AMC is also responsible for undertaking all marketing activities related to MGC’s products in the US, as well as taking care of import and warehousing matters.

Additionally, AMC will also be required to collect data from the end users of the products to be used for analysis by MGC.

MGC says the deal will result in US$3m revenue in 2021, but is subject to AMC receiving a National Clinical Trial Number (NCTN) by the end of September.

Obtaining the NCTN will enable hospitals in the US to become part of the ongoing clinical trials for CannEpil and CogniCann, as well as participating in the global clinical program for CimetrA.

“This is an important and exciting agreement for MGC Pharma, providing MGC access to the largest healthcare market in the world,” commented MGC Pharma co-founder and CEO, Roby Zomer.

“This agreement provides MGC Pharma with strong revenue streams over the next three years, with the possibility of larger revenues to follow, and the opportunity to be at the forefront of phyto-medicines in the USA.”


AMC’s expertise in the US market

AMC is a privately held company, dedicated to bringing clinical-stage biotech products from around the world into the US market.

Part of the company’s strength revolves around its extensive links to governmental institutions and hospitals around the country.

It also has decades of experience dealing with regulatory and political lobbying throughout North America,  which will be vital in enabling MGC Pharma’s products to be distributed across the US.

AMC’s board includes DEA’s Lifetime Achievement Award winner, Tampa attorney James Cusack, as well as former US Attorney, Bobby O’Neill.

O’Neill once headed the Justice Department’s Narcotic and Dangerous Drug Section.

The board also includes General Counsel Brent Yessin, who has represented major medical centres, academic teaching hospitals and health systems around the world.

Yessin said: “We believe that disease management of intractable conditions, like refractory epilepsy and dementia, as well as the recent spike in COVID around the US, is driving healthcare providers and researchers to seek alternatives to existing drugs or protocols.”

“MGC’s track record in developing botanical or bio-pharmaceutical solutions as alternatives to existing medications, many of which have negative side effects affecting patients’ quality of life, made this an exciting collaboration for AMC.”


MGC’s concurrent clinical trials

MGC Pharma is conducting concurrent clinical trials around the world for its product candidates – CannEpil, CogniCann, and CimetrA.

CannEpil is a phyto cannabinoid derived IMP (investigational medicinal product), designed to treat drug-resistant epilepsy with a high CBD and low THC formula.

The Phase IIb clinical trial for CannEpil is currently ongoing in Israel, and will focus on the safety and efficacy of CannEpil as an add-on treatment for children and adolescents with treatment resistant epilepsy, also known as refractory epilepsy.

CogniCann is a formulation of phyto cannabinoids that has been developed with the specific aim of treating the symptoms of dementia and Alzheimer’s.

The drug is currently undergoing a Phase II clinical trial at the University of Notre Dame in Perth, which has been designed to evaluate the potential behavioural benefits of CogniCann on patients with dementia and Alzheimer’s disease.

Meanwhile, CimetrA is a nano-micellular pharmaceutical synergetic composition consisting of curcumin, boswellia, artemisinin, and optionally cannabinoids and/or nitroxides.

The composition can be manufactured in liquids or in solid variant, and has antioxidant, anti- inflammatory, and anti- cancer properties.

Clinical results on CimetrA have indicated that it’s an effective treatment for addressing anti-inflammation and cytokine over-production (known as cytokine storm) in COVID-19 patients.


What’s next

The binding agreement is for an initial term of three years, with an option for AMC to extend a further three years based on milestones, including regulatory approvals and contracted order quantities.

The contracted minimum orders are for US$24m over the term of the agreement with orders to be paid for in advance of supply, except for the initial US$3m order which will be partly paid in advance with the balance covered by an irrevocable Letter of Credit.

As part of the deal, MGC Pharma will also take an undiluted 10% equity interest in each of AMC’s regional operating companies.

In return, AMC will be granted options on MGC shares with various strike prices that mature in four years.

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.