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RNS Number : 7816V
MGC Pharmaceuticals Limited
11 April 2023
MGC Pharmaceuticals Ltd.
CannEpil(R) now available by Named Patient Request in UK
11 April 2023
ASX, LSE: MXC
Highlights:
-- CannEpil(R) , MGC Pharma's Investigational Medicinal Product
("IMP") is now available in the United Kingdom by Named Patient
Request to be prescribed by doctors on The General Medical Council
("GMC") specialist register across the UK.
-- The products will be supplied in order to meet the needs of
an individual patients where an unmet medical need exists .
-- The availability via Named Patient Request follows the
announcement [1] that MGC Pharma is providing CannEpil(R) to an
observational trial supported by the I am Billy Foundation.
-- 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' or 'the Company') a
European based pharmaceutical company specialising in the
production and development of plant inspired medicines, is pleased
to announce that the Company's proprietary product, CannEpil(R) is
now available to patients in the UK by Named Patient Request. The
listing 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 (GMC
Register).
CannEpil(R)
The CannEpil(R) IMP formulation is a high-CBD, low-THC
formulation, delivered by oral mucosal solution, part of a clinical
development program for patients suffering from Refractory Epilepsy
(also known as Drug Resistant Epilepsy). A safety study completed
in Australia showed CannEpil(R) was safe for post-treatment driving
activities. [2] In 2019, CannEpil(R) was made available for
distribution and prescription in Ireland under full governmental
health insurance coverage, making it the first product available
with coverage in the Republic of Ireland under the Long Term
Illness and General Medical Services schemes. Hundreds of patients
have been prescribed CannEpil(R) across Australia and the Republic
of Ireland over the past three years.
The data collected from the patients will be used to further
evaluation of the safety and efficacy of the drug and will support
future submissions for marketing authorisation.
Epilepsy
Epilepsy accounts for a significant proportion of the world's
disease burden, affecting around 50 million people worldwide. The
estimated proportion of the general population with active epilepsy
(i.e. continuing seizures or with the need for treatment) at a
given time is between 4 and 10 per 1000 people. [3] Epilepsy is one
of the most common, serious neurological conditions, with
approximately 33% of adults, and 20-25% of children with Epilepsy,
suffering from Refractory Epilepsy (or Drug Resistant Epilepsy)
which cannot be controlled at least two antiseizure medications
(called ASMs). [4]
CBD has been proven to be effective in the sustained reduction
of seizure frequency and severity for epilepsy, which has been
supported by open-label studies, observational studies, Randomised
Clinical Trials (RCTs) and large-scale systematic reviews. [5]
Roby Zomer, Managing Director and CEO of MGC Pharmaceuticals,
commented : "T he availability of CannEpil(R) by Named Patient
Request marks a momentous breakthrough for MGC Pharma. The product
will now be available to a wide cohort of specialist medical
practitioners in the UK, which is testament to the progress we are
making."
" CannEpil's(R) availability in the UK for unmet medical need by
doctors on the GMC specialist register, is another material
milestone for the company within the healthcare and Life-Science
sector as an innovative plant-inspired pharmaceutical company".
" Stepping up to the Early Patient Scheme is a significant
demonstration of our Pharma footprint, and is a step closer to our
goal to be available to more patients in need for standardised
affordable treatment".
"We are extremely proud of the progress we have achieved thus
far, and we are pleased that CannEpil(R) has been selected as a
treatment within an observational patient trial in association with
the I am Billy Foundation. We look forward to updating the market
on the results of this trial in due course".
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 info@mgcpharma.co.uk
UK PR Advisors UK Brokers
Tavistock Peterhouse Capital
Charles Vivian / Tim Pearson Charles Goodfellow / Lucy Williams
+44 207 920 3150 +44 207 469 0930
mgcpharma@tavistock.co.uk cg@peterhousecap.com / lw@peterhousecap.com
UK Financial and Corporate Advisor
SW4 Partners
Rupert Fane / Nilesh Patel
rupert@sw4partners.com / nilesh@sw4partners.com
About GMC Specialist Register
The Specialist Register is a list of doctors who are eligible to
take up appointment in any fixed term, honorary or substantive
consultant post in the NHS, although specialist registration is not
a legal requirement for these posts in foundation trusts.
If a doctor is on the Specialist Register, it will say so as
part of their status on the medical register. Doctors can practice
in a specialty not shown on their Specialist Register entry. In
most cases, they must be on the Specialist Register in at least one
specialty to practise as a consultant in any of the UK health
services.
The GMC Specialist Register works to protect patient safety and
support medical education and practice across the UK. They do this
by working with doctors, employers, educators, patients, and other
key stakeholders in the UK's healthcare systems. There are more
than 359,000 doctors on the UK full Medical Register of which
108,000 are on the Specialist Register
About I am Billy
I am Billy is a foundation set up to aid parents and families in
navigating the challenges of obtaining NHS-funded Medical Cannabis
for children. The foundation provides financial assistance in
meeting the cost of cannabis based medical products (CBMPs)
prescribed by a medical consultant, in addition to advancing the
public understanding of the medical benefits of CBMPs.
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:
LinkedIn: MGC Pharmaceuticals Ltd.
Facebook: @mgcpharmaceuticals
Instagram: @mgc_pharma
Twitter: @MGC_Pharma
[1] Refer to ASX Announcement dated 15 March 2023
[2] Refer to ASX Announcement dated 15 August 2022
[3]
https://www.who.int/news-room/fact-sheets/detail/epilepsy
([4]) https://www.epilepsy.com/learn/drug-resistant-epilepsy
[5]
https://volteface.me/app/uploads/2022/11/Volteface-Report-_-Known-Unknowns.pdf
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