MGC Pharmaceuticals Ltd sees strong market outlook as global phytocannabinoid

() () () (FRA:H5O) sees a strong market outlook as the global phytocannabinoid market gains traction and the company prepares to supply the global market through its portfolio of established and upcoming products. 

The European-based, vertically integrated biopharma, has three investigational medical products (IMPs) in three clinical trials. 

It is also seeing a rapid-growing patient base, with a record December 2020 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™.

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.

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™, does not contain cannabinoids and is designed from four natural ingredients as a phytomedicine to target viral infections with inflammatory complications.

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.

The trial will evaluate the efficacy and safety of CimetrA™ in the treatment of moderate hospitalised patients diagnosed with coronavirus (COVID-19) on a large patient group.

The trial is expected to begin in early April and conclude in September, with interim and full results expected in June and October respectively.

The Phase III trial is currently undergoing regulatory approvals for additional clinical sites in Israel and Brazil.

The expected time to fast-tracked marketing authorisation is less than one year.

Preclinical R&D

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 preclinical stage, with Phase 1 planned in the second half of 2021.

Its InCann BiActive capsule to treat Chron’s and IBS is also in preclinical stage, with Phase 1 planned for the second half of 2021.

MGC drug delivery technology

MGC 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.

Manufacturing facilities

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 license.

The focus will be on IMPs.

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 will provide further distribution and direct patient access, boosting its next phase of growth across Australia.