MGC Pharmaceuticals (ASX: MXC) has been given the greenlight to begin manufacturing its medicinal cannabis-based products at its European production facility, after receiving interim Good Manufacturing Practice certification.
The interim licence allows MGC Pharma to immediately kick-off manufacturing its first batch of CannEpil™ – the company’s medical cannabis product for treating epilepsy in adults.
Once the first batch has been completed, it will be reviewed to ensure it meets required protocols.
MGC Pharma anticipates it will meet the protocols and be granted full Good Manufacturing Practice certification and pave the way for the company to begin full scale production and sales of CannEpil and its other medicinal cannabis-based products.
“MGC Pharma has a vision and defined strategy of becoming a leading pharmaceutical-grade medicinal cannabis company and the receipt of Good Manufacturing Practice certification for our European manufacturing facility is a key milestone on this journey,” MGC Pharma co-founder and chief executive officer Roby Zomer said.
“Once we receive full certification, we will be positioned to rapidly progress our operation in Europe with a core focus on medical research and development of the company’s pharmaceutical products pipeline,” Mr Zomer added.
MGC Pharma has an existing agreement with HL Pharma to bring the CannEpil™ to the Australian market, with HL Pharma working on gaining requisite final approvals from Australia’s Therapeutic Goods Agency and Office of Drug Control.
Once CannEpil™ hits the Australian market sometime early this year, MGC Pharma expects the product will generate at least A$1 million per annum in its first year of distribution in the country from less than 100 patients who are registered for the drug via Epilepsy Action Australia.
Mr Zomer said CannEpil™ will be an “affordable” treatment option for epilepsy sufferers. It will be sold in a 50ml bottle and comprise both cannabidiol and cannabinoids for oral administration.
According to MGC Pharma, the product will be “significantly lower” than competing products and retail under A$800.
The product is targeted at drug-resistant epilepsy suffers, which makes up about 30% of the 240,000 epilepsy sufferers diagnosed each year in Australia.
Shares in MGC Pharma soared on the news and were at A$0.12 in early afternoon trade – up almost 10%.