TIDMMXC
RNS Number : 8679B
MGC Pharmaceuticals Limited
15 June 2021
15 June 2021 MGC Pharmaceuticals Ltd.
ASX Code: CannEpil(R) added to Primary Care Reimbursement Service
MXC in Ireland for full patient cost rebate
LSE Code:
MXC
Key Highlights :
-- CannEpil(R) has been added to the Primary Care Reimbursement
Service in the Republic of Ireland (" Ireland ") as part of the
Medicinal Cannabis Access Programme (" MCAP "), making it free of
charge for Irish patients prescribed the treatment under the
MCAP.
-- CannEpil(R) is one of the first EU-GMP pharmaceutical grade
cannabis medicine products to be approved for prescription in
Ireland under the MCAP and under the Primary Care Reimbursement
Service, which is part of Ireland's Heath Service Executive (" HSE
").
-- This announcement follows the approval for distribution and
prescription of CannEpil(R) by Ireland's Department of Health in
December 2019 (refer announcement 3(rd) December 2019).
-- CannEpil(R), which is designed to treat Refractory Epilepsy,
also known as Drug Resistant Epilepsy, will enter a Phase IIb
Clinical Trial during Q3 2021 (refer announcement 25(th) May
2021).
-- Approximately 40,000 people in Ireland, and 50 million people
worldwide[1] suffer from epilepsy, with approximately 33% of
adults, and 20-25% of children, suffering from Refractory Epilepsy
(or Drug Resistant Epilepsy), which cannot be controlled with
traditional anti-seizure medication[2].
-- MGC delivers record sales of its core phytocannabinoid
derived medicine products in May, with its highest monthly revenue
of more than A$360,000, which excludes ArtemiC(TM) sales.
MGC Pharmaceuticals Ltd (ASX, LSE: MXC, 'MGC Pharma' or 'the
Company'), a European based bio-pharma company specialising in the
production and development of phytocannabinoid-derived medicines,
announces that its cannabis derived epilepsy Investigational
Medicinal Product (" IMP "), CannEpil(R), will now be fully covered
by the HSE in Ireland. This follows the incorporation of the MCAP
into the HSE's Service Plan, and under which CannEpil(R) is an
approved product for medical use, as defined in the legislation
(refer announcement 3rd December 2019).
Approval of CannEpil(R) to the HSE Service Plan
CannEpil(R) is a phytocannabinoid derived IMP, designed to treat
Drug Resistant Epilepsy with a high CBD, low THC formula, and was
made available for distribution and prescription in Ireland in 2019
as part of the MCAP. In January 2021, the Irish Department of
Health announced provision for the delivery and funding of the MCAP
through its inclusion in the HSE's Service Plan . CannEpil(R) is an
approved product for medical use and will 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, as defined in the legislation.
Medical professionals in Ireland can prescribe CannEpil(R) for
patients under their care for a range of medical conditions in
addition to Epilepsy. Other indications that CannEpil(R) has
already been prescribed for are Anxiety, Chronic Pain, Insomnia,
PTSD and Parkinson's Disease, all under Cannabis Access
Schemes.
CannEpil(R) is already being prescribed in Australia and the UK
in the treatment epilepsy.
CannEpil(R) is available through our Irish partner Georgelle
Ltd. Georgelle is one of Ireland's leading wholesale pharmaceutical
companies, supplying the country's network of hospitals and retail
pharmacies with Licensed & Exempt Medicinal Products. Epilepsy
is prevalent worldwide, with over 50 million people suffering from
seizures. Refractory (treatment-resistant) Epilepsy affects
approximately 33% adults and 20-25% of children already suffering
from epilepsy. In Ireland, there is a national prevalence of
treated epilepsy of 9 per 1,000 people for those over the age of 5,
meaning an estimated 37,000 epilepsy patient population.[3]
Further Phase IIb randomised, double blind, placebo controlled
clinical studies are to begin in Q3 2021 (refer announcement 25(th)
May 2021). This will take place at the Schneider Hospital in Israel
and will focus on the safety and efficacy of CannEpil(R) as a
supplementary treatment in children and adolescents with Refractory
Epilepsy.
Record monthly revenues of Phytocannabinoid medicine products in
May
The Board is pleased to report that the Company continues to
execute on the global sales strategy of its phytocannabinoid
derived medicines , with May delivering its best monthly revenue to
date of more than A$360,000.
This monthly sales revenue of over A$360,000 excludes all
non-cannabinoid products including the material ArtemiC(TM) supply
contracts announced in 2021, demonstrating the continued and
strengthening sales pipeline within its core phytocannabinoid
business, led by the Company's Global Chief Sales Officer Nicole
Godresse. With recent developments including the inclusion of
CannEpil(R) on the HSE Service Plan for the Republic of Ireland,
the Company is well positioned to continue the growth of the
commercial side of the business through H2 2021 in line with its
core business milestones.
Roby Zomer, Co-founder and Managing Director of MGC Pharma,
commented: "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. Furthermore, this is a critical
moment in the roll out of CannEpil(R) 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(R) available free to access for patients in Ireland, this
will now be the case. Combined 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 .
With further Clinical Trials of CannEpil(R) 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."
--Ends--
Authorised for release by the Board, for further information
please contact:
MGC Pharmaceuticals UK PR Advisors - Tavistock
Ltd Tim Pearson
Roby Zomer +44 207 920 3150
CEO & Managing Director Tim.Pearson@tavistock.co.uk
+61 8 6382 3390
info@mgcpharma.com.au
UK Broker - Turner Australian IR Advisors - Media
Pope & Capital Partners
Andy Thacker Rod Hinchcliffe
+44 203 657 0050 +61 412 277 377
info@turnerpope.com Rod.Hinchcliffe@mcpartners.com.au
About MGC Pharma
MGC Pharmaceuticals Ltd (LSE: MXC, ASX: MXC) is a European based
bio-pharma company developing and supplying affordable standardised
phytocannabinoid derived medicines to patients globally. The
Company's founders were key figures in the global medical cannabis
industry and the core business strategy is to develop and supply
high quality phytocannabinoid derived medicines for the growing
demand in the medical markets in Europe, North America and
Australasia. MGC Pharma has a robust product offering targeting two
widespread medical conditions - epilepsy and dementia - and has
further products in the development pipeline.
Employing its 'Nature to Medicine' strategy, MGC Pharma has
partnered with renowned institutions and academia to optimise
cultivation and the development of targeted phytocannabinoid
derived medicines products prior to production in the Company's
EU-GMP Certified manufacturing facility.
MGC Pharma has a number of research collaborations with world
renowned academic institutions, and including recent research
highlighting the positive impact of using specific phytocannabinoid
formulations developed by MGC Pharma in the treatment of
glioblastoma, the most aggressive and so far therapeutically
resistant primary brain tumour.
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] Source:
https://www.epilepsy.ie/content/epilepsy-explained
[2] Source:
https://www.epilepsy.com/learn/drug-resistant-epilepsy
[3] Source: The prevalence of Epilepsy in Ireland
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