MGC Pharmaceuticals (MXC ) has signed a binding supply agreement with US company, AMC Holdings covering minimum orders of $24 million for MGC’s phytomedicine products. 

MGC, an EU based bio-pharma firm which specialises phytocannabinoid-derived medicines, said this is the first dedicated supply agreement it has executed for the supply of MGC Pharma pharmaceutical products into the USA, the largest healthcare market in the world. 

The deal is considered ‘an important step’ in expediting the clinical trials process for both CannEpil® and CogniCann®, and to provide access to these medicines to more patients. 

CannEpil® is a phytocannabinoid derived IMP, designed to treat Drug Resistant Epilepsy with a high CBD, low THC formula while CogniCann® is a formulation of phytocannabinoids developed with the specific aim of treating the symptoms of Dementia and Alzheimer's.  

A Phase IIb clinical trial for CannEpil®, which has regulatory approval at the Schneider Children's Medical Hospital in Israel, is focusing on the safety and efficacy of CannEpil® as an add-on treatment for children and adolescents with treatment resistant epilepsy, or Refractory Epilepsy. This trial is targeting the recruitment of more than 100 patients. 

Today’s agreement with AMC follows on from CannEpil® being added to the Primary Care Reimbursement Service in the Republic of Ireland in June 2021, making it free of charge for Irish patients prescribed the treatment under the Medical Cannabis Access Program. 

Highlighting the size of the market for CannEpil®, MGC noted that around 50 million people globally suffer from epilepsy, with around 33% of adults, and 20-25% of children, suffering from Refractory Epilepsy, which can’t be controlled with traditional anti-seizure medication.  

CogniCann® is currently undergoing a Phase II clinical trial at the University of Notre Dame in Perth which has 21 patients currently enrolled, and is designed to evaluate the potential behavioural benefits of the drug on patients with Dementia and Alzheimer's disease.

The deal will also cover the Company’s CimetrA™ product. Pre-clinical and clinical results to date have shown CimetrA™ to be an effective treatment for addressing anti-inflammation and Cytokine overproduction (known as Cytokine Storm) in all tested COVID-19 patients. 

AMC, which was founded by leading US Healthcare and ex-Federal Government legislative and regulatory executives as a specialist vehicle for specialist phytomedicines into key US markets, said it is seeking to expand the research and growth of phytomedicines in the USA. Addressing shareholders, AMC said it considers MGC Pharma as the leader in this sector. 

Under the terms of this latest deal, and as the licensed distributor of MGC Pharma products in the USA, AMC will undertake all marketing activities in the US, as well as managing the import and warehousing of the products. To assist with product development activities, AMC will also collect data from the end users of the products for analysis by MGC Pharma. 

Shares in MGC Pharmaceuticals soared by 40.96% to 2.925p following this morning’s news. 

The deal includes a minimum $3m of sales in Year 1, subject to AMC receiving a National Clinical Trial Number (NCTN) for a MGC Pharma product by the end of September 2021.  

Obtaining the NCTN will enable hospitals in the United States to participate in the ongoing clinical trials for CannEpil® or CogniCann® under approval of the Global Ethics Committee. The Company explained that AMC is already ‘well advanced’ in this registration process. 

To initiate the registration process for CimetrA® in the US, MGC said US based clinical sites will be added to the global clinical trial program for CimetrA®. AMC and MGC will first seek approval to distribute and issue CannEpil® to patients via Florida's Early Access Scheme. 

Roby Zomer, Co-founder and MD of MGC Pharma, said: "This is an important milestone agreement for MGC Pharma, as it provides MGC access to the largest healthcare market in the world. We look forward to working with our new partners at AMC and utilising their expertise and network to widen patient access to MGC's phytomedicine products.” 

Zomer said the agreement with AMC Holdings will provide MGC Pharma with a pipeline for strong revenue streams over the next three years, with the possibility of larger revenues to follow, as well as the opportunity to be at the forefront of phytomedicines in the USA.  

He said: “Additionally, the ability to add new sites to our current clinical trials programmes for CannEpil® and CogniCann® will greatly enhance the ongoing process for both.” 

Speaking on the deal, AMC's General Counsel and President of AMC Florida Brent Yessin added:  "We believe that disease management of intractable conditions, like Refractory Epilepsy and Dementia, as well as the recent spike in COVID 19 around the US, is driving healthcare providers and researchers to seek alternatives to existing drugs or protocols.” 

He concluded: “MGC's track record 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.” 

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