MGC Pharma on brink of European medical cannabis approval
ASX-listed MGC Pharmaceuticals is on track to hit a major commercial milestone, with the medical marijuana upstart on the brink of receiving official approval for its European cannabis production and manufacturing facility.
In a market update this week, the Perth-listed company, which has pharmaceutical, dermatological and botanical divisions, said it remained on track to receive the official green light for the Slovenian facility this month after being granted an interim Good Manufacturing Practice or “GMP” licence in January.
The final GMP approval is one of the final regulatory hurdles for the company in its journey to commercially produce CannEpil, a pharmaceutical grade medical cannabis product for the treatment of drug resistant and severe forms of epilepsy.
Once GMP certification is granted for the laboratory and compounding facility, MGC said it would focus on GMP certification for its European extraction facility, marking the final step in the 18-month-long approvals process.
The big payoff is that after both certifications are received, the ASX Junior will have a fully-integrated GMP facility for the future extraction, compounding and production of new pharmaceutical grade cannabis-based medicines.
According to MGC, drug resistant epilepsy accounts for around 30 per cent of the estimated 240,000 people diagnosed with epilepsy each year, with CannEpil already approved for use in Australia.
The company expects to generate about $1 million per year in revenue from the less than 100 patients already registered for the product in Australia.
MGC CEO Roby Zomer said: "It has been a very busy few months, with the management team focused on completing some key operational milestones and a number of strategic discussions that could provide a huge opportunity to fast track our Pharma operations in a number of geographies."
"We've made strong progress across all three divisions, and are fast approaching a major milestone for our Pharma division, with GMP certification imminent, following the first production of CannEpil which is on track for March."
In the latest update, the company also said that it had commenced partnership discussions with several leading Israeli medicinal cannabis research centres over the past three months.
Other positive developments included the start of the first 2018 crop at MGC's Czech Republic glasshouse facility using a new generation strain of cannabis genetics and the extraction of cannabinoids from last year's Czech botanical harvest due to be completed soon.
Additionally, MGC said it was looking at potential strategic investment and joint venture opportunities with established licensed marijuana producers in Australia and North America to accelerate its operations in both regions.