MGC Pharmaceuticals (LSE:MXC) said this morning it had signed a binding US market supply and distribution agreement with AMC Holdings in the US. It represents minimum orders of $24 million for MGC products over an initial three year period.
This is the first dedicated supply agreement executed by MGC Pharma for the supply of MGC Pharma pharmaceutical products into the USA, the largest healthcare market in the world. The agreement with AMC is also an important step in expediting the clinical trials process for some of MGC’s new products, as well as providing access to these medicines to more patients.
Deal is big boost for MGC Pharma share price
Shares in MGC Pharma had been trading at around 2.1p yesterday. They spiked on the news to 3.84p. At time of writing they were trading at close to 3.5p but losing momentum. The sudden move is typical for a smaller, sub-A$100m pharma play which secures a deal on this scale.MGC Pharma is a bio-pharma company specialising in the production and development of phytocannabinoid-derived medicines.
AMC itself was founded by leading US Healthcare and ex-Federal government legislative and regulatory executives, and is a specialist vehicle for the import and distribution of specialist phytomedicines into key US markets.
AMC Holdings will spearhead distribution and approvals
AMC will seek US regulatory approvals for all products which they intend to distribute, including import licenses, as well as undertaking clinical trials in the US, all the way through to US Food and Drug Administration approval.
The news is, dare we say it, a shot in the arm for the struggling drug developer which had seen its share price drop from a 52 week high of 9.3p. Investors will be focused on the small terms of an agreement which holds out the potential to really boost the fortunes of MGC.
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.
Epilepsy and Covid 19 treatments in focus
The deal includes a minimum $3 million 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 USA to participate in the ongoing clinical trials under approval of the Global Ethics Committee. With AMC are already well advanced in this registration process.
“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,” said Brent Yessin, General Counsel at AMC. “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. We look forward to introducing MGC’s products to our national medical community.”
US based clinical sites will be added to the global clinical trial program for MGC product CimetrA in order to initiate the registration process for CimetrA in the US. AMC and MGC will first seek approval to distribute and issue another product, CannEpil, to patients via Florida’s Early Access Scheme.
CannEpil is a phytocannabinoid derived IMP, designed to treat Drug Resistant Epilepsy with a high CBD, low THC formula. The Phase IIb clinical trial for CannEpil already has regulatory approval at the Schneider Children’s Medical Hospital in Israel and is focusing 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.
Drugs already being used in Ireland and Israel
The agreement with AMC follows on from CannEpil being added to the Primary Care Reimbursement Service in the Republic of Ireland in June, making it free of charge for Irish patients prescribed the treatment under the Medical Cannabis Access Program.
CimetrA is a nano-micellar pharmaceutical synergetic composition consisting of curcumin, boswellia, artemisinin, and optionally cannabinoids and/or nitroxides. The composition can be manufactured in liquids or in solid pharmaceutically acceptable carriers, has antioxidant, anti-inflammatory, immuno-modulating and anti-viral properties and can be designed for multiple therapeutic applications utilising self-nanoemulsifying drug delivery systems.
Preclinical and clinical results to date support the pharmaceutical composition of CimetrA as an effective treatment for addressing anti-inflammation and cytokine over-production (known as Cytokine Storm) in all tested COVID-19 patients.
