MGC Pharmaceuticals - First CannEpil® delivered to UK patients

Argent BioPharma

31/05/2023 07:00

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RNS Number : 1444B  MGC Pharmaceuticals Limited  31 May 2023

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-

Authorised for release by the board of directors, for further information
please contact:

 MGC Pharmaceuticals Ltd                                                     MGC Pharmaceuticals Ltd

 Roby Zomer                                                                  Arron Canicais / Rowan Harland

 CEO & Managing Director                                                     Joint Company Secretaries

 +61 8 6382 3390                                                             +61 8 6382 3390

 info@mgcpharma.co.uk (mailto:info@mgcpharma.co.uk)                          info@mgcpharma.co.uk (mailto:info@mgcpharma.co.uk)
 UK Brokers                                                                  UK Brokers

 Peterhouse Capital                                                          Oberon Capital

 Charles Goodfellow / Lucy Williams / Duncan Vasey                           Aimee McCusker / Adam Pollock

 +44 207 469 0930                                                            +44 203 179 5300

 cg@peterhousecap.com (mailto:cg@peterhousecap.com) / lw@peterhousecap.com   aimeemccusker@oberoninvestments.com
 (mailto:lw@peterhousecap.com)                                               (mailto:aimeemccusker@oberoninvestments.com) adampollock@oberoninvestments.com
                                                                             (mailto:adampollock@oberoninvestments.com)
 UK IR/PR Advisers

 IFC Advisory

 Graham Herring / Tim Metcalfe / Zach Cohen

 +44 203 934 6630

 mgcpharma@investor-focus.co.uk (mailto:mgcpharma@investor-focus.co.uk)

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.

 

Follow us through our social media channels:

Twitter: @MGC_Pharma

Facebook: @mgcpharmaceuticals

LinkedIn: MGC Pharmaceuticals Ltd.

Instagram: @mgc_pharma

 

 1  Refer to ASX Announcement dated 15 August 2022

 2  Refer to ASX Announcement dated 3 December 2019

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