MGC Pharmaceuticals Ltd (ASX:MXC) (LON:MXC) (OTCMKTS:MGCLF) (FRA:H5O) is poised to supply the global phytocannabinoid-derived medicines market with its portfolio of established and upcoming products through its worldwide distribution footprint and expanding patient base.
The European-based, vertically integrated biopharma company has a growing patient base in Australia, the UK, Brazil and Ireland and a global distribution footprint through its extensive network of commercial partners.
MGC Pharma, which has three investigational medical products (IMP) in three clinical trials, also reported a record March 2021 quarter of sales and revenue, as it delivers affordable cannabinoid medicines to patients.
Three products in clinical trials
MGC Pharma has commenced clinical trials for three of its key Phytomedicine products CannEpil®, CogniCann® and CimetrA™.
CannEpil® is designed as a treatment for refractory epilepsy.
Phase IIb clinical trial is being conducted at the Schindler Hospital in Israel on the safety and efficacy of CannEpil® as an add-on treatment in children and adolescents with refractory epilepsy.
The expected time to marketing authorisation is four years.
CogniCann® is aimed at improving dementia and Alzheimer’s disease patients’ quality of life.
Phase II clinical trial is being carried out with the University of Notre Dame in Perth to evaluate the potential behavioural benefits CogniCann® may have on patients with dementia and Alzheimer’s disease.
The expected time to marketing authorisation is five years.
CimetrA™, as a treatment to offset the Cytokine Storm and other auto-immune indications, does not contain cannabinoids and is designed from four natural ingredients as a phytomedicine to target viral infections with inflammatory complications.
In December 2020, the company completed its Phase II clinical trial at Nazareth Hospital EMMS, Hillel Yaffe Hospital in Israel and Mahatma Gandhi Mission’s Medical College & Hospital in India.
During the trial, CimetrA™ met all its primary and secondary endpoints and statistically significantly improved the clinical recovery of COVID-19 infected patients.
In March 2021, CimetrA™ received the Ethics Committee approvals from the Rambam Health Care Campus and the Nazareth Hospital EMMS in Israel for Phase III clinical trials on patients diagnosed with coronavirus.
These trials will evaluate the efficacy and safety of CimetrA in the treatment of moderate hospitalised patients diagnosed with COVID-19 on a large patient group.
This will provide additional data for claims on the product as an IMP, as well as essential data to plan for a future regulatory pathway for the registration of CimetrA as a drug.
The trial is expected to begin in early April and conclude in September, with interim and full results expected in June and October respectively.
This Phase III trial is going through regulatory approvals for additional clinical sites in Israel and Brazil and the expected time to fast-tracked marketing authorisation is less than one year.
The company is also developing medicines that leverage its proprietary medical cannabis formula through clinical trials in Israel, Europe and Australia.
This will enable future medical product sales across the EU, Australia and other geographies, after clearing the legal and regulatory approvals.
Its MXOT01GB01 for the treatment of Glioblastoma is in the pre-clinical stage, with Phase 1 planned in the second half of 2021.
Its InCann BiActive capsule to treat Chron’s and IBS is also in the pre-clinical stage, with Phase 1 planned for the second half of 2021.
Proprietary MGC drug delivery technology
MGC Pharma is currently conducting research development on smart nanostructured materials to deliver drugs to the target sites with reduced dosage frequency and in a controlled manner, to mitigate the side effects experienced with traditional therapies.
In particular, it is looking to resolve the main critical issues encountered with conventional pharmaceutical treatments.
Its Slovenia EU-GMP certified facility has the capacity to manufacture up to 12,000 prescription products per month and has a three-year GMP licence.
The focus will be on IMP.
Its CimetrA™ manufacturing facility in Malta is expected to be operational in October 2021.
Both plants will have a combined capacity of 200,000 units per month under GMP conditions within the EU.
Global distribution partners
The company’s wholesaler/exporters, Lenis, works with distributors globally and is also a direct distributor to key European markets.
Further, the acquisition of Medicinal Cannabis Clinics (MCC) will provide further distribution and direct patient access, boosting its next phase of growth across Australia.
Taking supply chain all the way
With the acquisition of MCC in November 2020, MGC Pharma is taking ownership of the supply chain all the way to the patient.
The Australian telehealth medicinal cannabis clinic offers an extensive doctor, pharmacy and patient network – with an established operating platform with over 600 pharmacy and doctor accounts.
It provides more than 4,500 medical cannabis consultations and allows medication to be dispensed and delivered straight to the patient’s doorstep.
The acquisition optimises control of the supply chain from manufacturing through to patients, improving profit margins and providing high-quality GMP certified medications at affordable prices.
MCC is now operating under MGC Pharma’s management control and cost structures and starting to deliver the business synergies.
First bulk order of ArtemiC™ Rescue
MGC Pharma completed delivery of the first bulk order in March 2021 of ArtemiC™ Rescue to leading European nutraceutical producer and distributor Swiss PharmaCan AG, equating to around $425,000 (€275,000) in wholesale production revenue to the company.
The order is part of a quarterly wholesale order under the master agreement with Swiss PharmaCan, which is to run for a minimum of three years.
Swiss PharmaCan plans to exclusively distribute ArtemiC™ Rescue worldwide, with specific focus on countries currently reporting high numbers of COVID-19 patients.
ArtemiC™ is a clinically tested food supplement (nutraceutical, dietary supplement, natural health product) containing four natural-based ingredients consisting of Artemisinin, Curcumin, Boswellia serrata, and Vitamin C.
Record quarter of sales revenues
The company delivered a record quarter of sales revenues from its proprietary phytomedicine product line, with about $880,000 of revenue generated for the March 2021 quarter.
March also delivered the best monthly sales revenue for the company to date from its pharmaceutical-grade phytomedicine products, with sales of the MP product line in Australia driving its best monthly unit sales to date with more than 1,500 units sold.
Sales growth of the company’s pharma grade, cannabinoid products also has continued in key markets, including Australia in the first quarter of 2021.