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RNS Number : 1444B
MGC Pharmaceuticals Limited
31 May 2023
First CannEpil(R) delivered to UK patients through I AM Billy
Foundation and GMC Specialist Register
31 May 2023
ASX/LSE: MXC
Highlights
-- CannEpil(R), 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(R) through the 'I
AM Billy Foundation', supporting the RESCAS study.
-- Additionally, the Company has delivered CannEpil(R) to its
first patient in the UK via the Named Patient Request
programme.
-- This follows the announcement on 11 April 2023 that
CannEpil(R) 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(R) 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(R), MGC Pharma's IMP has now been
successfully imported and received by its first patients in the
United Kingdom.
CannEpil(R)
The CannEpil(R) 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(R) was
safe for post-treatment driving activities[1]. In 2019, CannEpil(R)
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(R) 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(R) 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(R) 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(R) has been received by the first patient
in the UK via Named Patient Request. This enables CannEpil(R) 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(R)
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(R) 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
CEO & Managing Director Harland
+61 8 6382 3390 Joint Company Secretaries
info@mgcpharma.co.uk +61 8 6382 3390
info@mgcpharma.co.uk
UK Brokers UK Brokers
Peterhouse Capital Oberon Capital
Charles Goodfellow / Lucy Williams Aimee McCusker / Adam Pollock
/ Duncan Vasey +44 203 179 5300
+44 207 469 0930 aimeemccusker@oberoninvestments.com
cg@peterhousecap.com / lw@peterhousecap.com adampollock@oberoninvestments.com
UK IR/PR Advisers
IFC Advisory
Graham Herring / Tim Metcalfe / Zach
Cohen
+44 203 934 6630
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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