European-based biopharma company MGC Pharmaceuticals (ASX:MXC) has announced that its epilepsy drug, CannEpil, will now be fully covered under Ireland’s Primary Care Reimbursement Service as part of the country’s Medicinal Cannabis Access Programme (MCAP).

This major breakthrough means that CannEpil will be free of charge for Irish patients prescribed the treatment under the MCAP.

With this announcement, the drug will be one of the first EU‐GMP pharmaceutical grade cannabis medicine products to be approved for prescription in Ireland under the MCAP, which falls under Ireland’s Heath Service Executive (HSE).

The move by the country follows the incorporation of the MCAP into the HSE’s Service Plan in January, under which CannEpil is an approved product for medical use, as defined in the legislation.

Approval of CannEpil in Ireland’s HSE Service Plan

In December 2019, CannEpil was made available for distribution and prescription in Ireland as part of the MCAP, announced by the Department of Health.

Then in January this year, the department announced provision for the delivery and funding of the MCAP through its inclusion into the HSE’s Service Plan.

CannEpil falls under this new provision, and will now be available free of charge to patients under the Long‐Term Illness Scheme, GMS (Medical Card) Scheme, and the Drugs Payment Scheme on a named‐patient basis.

This means that medical professionals in Ireland can prescribe CannEpil for patients under their care for a range of medical conditions, in addition to epilepsy.

Other indications for which CannEpil has already been prescribed for include anxiety, chronic pain, insomnia, PTSD, and Parkinson’s disease.

In Ireland, the drug is available through MXC’s Irish partner Georgelle, one of Ireland’s leading wholesale pharmaceutical companies.

“This is a key moment for MGC Pharma and for the Irish patients who can now receive cannabis‐based treatments covered by the National Health Insurance,” said MGC Pharma CEO Roby Zomer.

“Furthermore, this is a critical moment in the rollout of CannEpil both in Ireland and worldwide. Our goal is to improve the lives of people who suffer with refractory epilepsy and other indications, and by making CannEpil available free to access for patients in Ireland, this will now be the case.”

CannEpil is already being prescribed in Australia and the UK for the treatment of epilepsy.

The CannEpil Phase IIb clinical study

CannEpil, which is short for Cannabis Epilepsy, is a phytocannabinoid-derived Investigational Medicinal Product (IMP) drug, designed to treat drug-resistant refractory epilepsy with a high CBD, low THC formula.

The drug is entering a Phase IIb clinical trial at the Schindler Hospital in Israel in Q3 of this year.

That study will focus on the safety and efficacy of CannEpil as an add-on treatment in children and adolescents with refractory epilepsy, with more than 100 patients to be recruited.

The drug is meant to reduce seizures targeting the severe cases of epilepsies for patients who experience more than 10 seizures a day.

Speaking to Stockhead recently, Zomer said those patients represent 25 per cent of all epilepsy patients.

“So we’re talking about a very large group of patients. If we want to compare it to Dilex, which is an FDA approved drug, they only target 2% of the epilepsy patients. CannEpil is targeting a much larger group,” explained Zomer.

Epilepsy is prevalent worldwide, with over 50 million people suffering from seizures.

Refractory (treatment‐resistant) epilepsy affects approximately 33% adults, with 20‐25% of children already suffering from epilepsy.

In Ireland itself, there is a national prevalence of treated epilepsy of nine per 1,000 people for those over the age of 5, meaning an estimated 37,000 epilepsy patient population.

MGC Pharma’s record monthly revenues

In separate news, MGC Pharma has continued to execute on its global sales strategy for phytocannabinoid derived medicines, delivering its best monthly revenue to date of more than $360,000 in May.

This monthly sales revenue is for all non‐cannabinoid products, including the material ArtemiC supply contracts announced in 2021.

The solid trading update demonstrates the company’s strengthening sales pipeline within its core phytocannabinoid business, led by its global chief sales officer, Nicole Godresse.

With today’s announcement in Ireland, MGC says it is now well positioned to continue the growth of the commercial side of the business through the second half of 2021, in line with its core business milestones.

“With record monthly sales in May for our leading phytocannabinoid derived medicines, the company continues to deliver on its goal of building a strong and sustainable global bio‐pharma business,” said Zomer today.

“With further clinical trials of CannEpil underway, we hope to be able increase the supply and availability of the medicine in the most affordable way to epilepsy sufferers globally in the near future.”



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