Special Report: Cannabis stock MGC Pharma will start its European tour in Big Pharma favourite Ireland after receiving a key approval for the EU market.

Europe-based cannabis biopharma MGC Pharma (ASX:MXC) has received regulatory approval for its drug-resistant epilepsy treatment CannEpil in Ireland.

The Irish Health Products Regulatory Authority (HPRA) approval for CannEpil will help the Australian-listed company enter mainland Europe markets under a follow-on mutual recognition program.

MGC’s approval was issued by the Irish Ministry of Health and is set to make CannEpil one of the first cannabinoid-based medicines to be approved for prescription and sale under the EU country’s Medical Cannabis Access Program.

Seed-to-medicine-focused MGC plans to then debut its investigational medicinal product (IMP) in other EU member states.

MGC co-founder and managing director Roby Zomer lauded the EU approval win, saying, “not only does it allow MGC Pharma’s GMP-certified medical products to reach more patients in need, but can be seen as a catalyst for fast-tracking follow-on approval applications to prescribe in other EU member state countries.”

Distribution agreements are already in place for the company’s expected European debut in EU member nations such as Germany, Austria, Italy and France.

Zomer noted the Cann-do-pharma’s market readiness, saying “we are well positioned for a quick entry to these markets following receipt of the required approvals.”

Western Australia-headquartered MGC’s first shipment in Ireland is ready to go.

“The sale of CannEpil into Ireland is now able to commence,” Zomer said.

“With an increasing number of patients being treated for drug-resistant epilepsy in Ireland, we believe that the high levels of demand from patients and doctors witnessed in the UK and Australia will be replicated in Ireland.”

Once the West Perth company’s drug is available in Ireland, it can be authorised in other member states under a mutual recognition scheme arrangement.

Revenues in the bag

MGC has been hitting milestones as it exceeds prescription and revenue records for its phytocannabinoid-derived medicines.

The company had issued a record 1400 prescriptions in Australia for its phytocannabinoid-derived CannEpil epilepsy treatment and MXP100 therapeutic for mild neurological disorders and inflammation by the end of November 2019.

Filling 22 prescriptions a day, the company has been writing revenues Down Under and in the UK as it sets Latin America in its sights.

Prescription growth rate is expected to escalate this month and beyond as the number of Australians receiving prescription cannabis medicines in the past year reached 14,357 people by this month.

More than 28,000 new patient approvals are expected by the end of the calendar year.

To meet demand, MGC’s Slovenia-based manufacturing facility has capacity to make standardised pharmaceutical-grade medicines for up to 5000 patients a month.

The $46.47m company had a major win last month for its South American program after the company signed a 50:50 joint venture partner, BrasilInvest Group, to help it secure a distribution premiere in Brazil.

China is also in MGC’s future.

MGC was a cannabis-stock volume trader on the ASX yesterday, with 1.5 million or $52,700 of shares changing hands in the $46.5 million company by final bell.

The trader’s share price closed up 0.1c, or 3 per cent, to 3.4c

>> Now watch: 90 Seconds With… Roby Zomer, MGC Pharmaceuticals



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This story was developed in collaboration with MGC Pharmaceuticals Ltd, a Stockhead advertiser at the time of publishing.
This story does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.