MXC.L Regulatory News (MXC)

First CannEpil® delivered to UK patients through I AM Billy Foundation and GMC Specialist Register

31 May 2023

ASX/LSE: MXC

Highlights

· CannEpil®, MGC Pharma's Investigational Medicinal Product ("IMP") has now been successfully imported and received by its first patients in the United Kingdom.

· The first UK patient has received CannEpil® through the 'I AM Billy Foundation', supporting the RESCAS study.

· Additionally, the Company has delivered CannEpil® to its first patient in the UK via the Named Patient Request programme.

· This follows the announcement on 11 April 2023 that CannEpil® was now available in the United Kingdom via Named Patient Request, and available to be prescribed by doctors on The General Medical Council ("GMC") specialist register across the UK.

· CannEpil® is in the process of a clinical development programme for patients suffering from refractory (or drug-resistant) epilepsy.

MGC Pharmaceuticals Ltd ("MGC Pharma", "MGC" or the "Company") a European based pharmaceutical company specialising in the production and development of plant inspired medicines, is pleased to announce that CannEpil®, MGC Pharma's IMP has now been successfully imported and received by its first patients in the United Kingdom.

CannEpil®

The CannEpil® IMP formulation is a high-CBD, low-THC formulation, delivered by an oral mucosal solution and is part of MGC's clinical development programme for patients suffering from refractory epilepsy (also known as drug-resistant epilepsy). A safety study completed in Australia showed that CannEpil® was safe for post-treatment driving activities[1]. In 2019, CannEpil® was made available for distribution and prescription in Ireland under full governmental health insurance coverage, making it available in the Republic of Ireland under the Long-Term Illness and General Medical Services schemes[2].

MGC Pharma has consistently supported research into refractory epilepsy, which is an important area of unmet medical need and will be providing both its investigational medicine CannEpil® and the proprietary ZAM app. As previously announced on 15 March 2023 the app will record daily metrics from patients, their symptoms, and the impact of their treatment in order to establish a baseline. This will provide both medical practitioners and MGC Pharma with a detailed record of the study and an enhanced understanding of the effect of CannEpil® on refractory epilepsy patients.

I AM Billy Foundation

The I AM Billy Foundation is led by Charlotte Caldwell whose epileptic son Billy caused changes to the law when he was granted the first NHS prescription for medical cannabis in 2018 after medications his mother flew in from Canada were seized at Heathrow Airport. Currently, around 25,000 people in the UK are being treated with medical cannabis for conditions including chronic pain, epilepsy, and Parkinson's disease, though the vast majority of prescriptions have been issued through expensive private healthcare schemes with patients struggling to get access to the medicines via the NHS.

MGC Pharma provided CannEpil® to the I AM Billy Foundation through the NHS's Refractory Epilepsy Specialist Clinical Advisory Service, currently the only route in the UK for patients to receive public funding for cannabis-based treatments of refractory epilepsy.

Additionally, CannEpil® has been received by the first patient in the UK via Named Patient Request. This enables CannEpil® to be prescribed by clinicians in the UK who are listed on the GMC Specialist Register, a significant sub section of the United Kingdom's central doctors register (the GMC Register).

Roby Zomer, Managing Director and CEO of MGC Pharma, commented: "The fulfilment of the first UK patient to receive CannEpil® undergoing the RESCAS process demonstrates the commitment of MGC Pharma to improve patient access to effective epilepsy treatment".

"We know there is a huge unmet need for epilepsy treatment, and we are pleased to be partnering with I AM Billy Foundation on this important work. With our combined knowledge, expertise, and capabilities, our aim is to facilitate patient access to the highest-quality cannabis-based medicinal products for patients with this huge unmet need".

"Additionally, with CannEpil® being prescribed via Named Patient Request for the first time, MGC Pharma is making significant progress in its mission to widen access to effective refractory epilepsy treatment and breaking the glass ceiling of such products to support unmet medical needs in the United Kingdom and Ireland, with other key territories hopefully to shortly follow this lead." 

-Ends-

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About MGC Pharma

MGC Pharmaceuticals Ltd (LSE: MXC, ASX: MXC) is a European based pharmaceutical company, focused on developing and supplying accessible and ethically produced plant inspired medicines, combining in-house research with innovative technologies, with the goal of finding or producing treatments to for unmet medical conditions.

The Company's founders and executives are key figures in the global pharmaceuticals industry and the core business strategy is to develop and supply high quality plant inspired medicines for the growing demand in the medical markets in Europe, North America and Australasia.

MGC Pharma has a robust development pipeline targeting two widespread medical conditions and has further products under development. 

MGC Pharma has partnered with renowned institutions and academia to optimise the development of targeted plant inspired medicines, to be produced in the Company's EU-GMP Certified manufacturing facilities. 

MGC Pharma has a growing patient base in Australia, the UK, Brazil and Ireland and has a global distribution footprint via an extensive network of commercial partners meaning that it is poised to supply the global market.

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