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MGC Pharmaceuticals Limited
19 December 2023
MGC Pharmaceuticals Ltd.
ArtemiC(TM) receives FDA Approval in Saudi Arabia
19 December 2023
ASX, LSE: MXC
MGC Pharmaceuticals Ltd (MGC Pharma, MGC or the Company), a
European based pharmaceutical company specialising in the
production and development of innovative medicines for unmet
medical needs, is pleased to announce that it has been granted
approval for its proprietary product ArtemiC(TM) by the Food and
Drug Authority in the Kingdom of Saudi Arabia (Saudi FDA).
Following the success of Phase II clinical trials[1] and
European studies on its effectiveness in assisting with the
recovery of patients from Covid and long-term Covid, ArtemiC(TM)
has now been approved by the Saudi FDA as an over-the-counter (OTC)
dietary supplement.
In addition, MGC Pharma appointed specialist consultancy Capital
Blossom Ltd in 2022 as its agent to the Kingdom of Saudi Arabia,
Sultanate of Oman, United Arab Emirates, Bahrain, Kuwait, and
Qatar.
Capital Blossom, through its joint venture collaboration with
its Saudi partner have worked on obtaining the approval of the
Saudi FDA.
Roby Zomer, CEO and Managing Director of MGC, commented : "We
are delighted to receive Saudi FDA approval for ArtemiC(TM) which
validates our product and follows the progress we had in USA
earlier this year. We are hopeful this will materialise into
commercial orders for MGC as we work closely with Capital Blossom
Ltd who are specialists in this territory.
About ArtemiC(TM)
ArtemiC(TM) is a clinically tested product. Developed by MGC
Pharma, it incorporates GraftBio(R) SNEDD technology, which
increases the bioavailability of ArtemiC(TM)'s active
ingredients.
In a Phase II double-blind, placebo-controlled Clinical Trial on
50 patients with COVID-19, ArtemiC(TM) demonstrated the following
advantages:
-- A full safety and efficacy profile with no drug-adverse
events.
-- The ability to prevent deterioration of COVID-19 patients and
achieve faster clinical improvement.
-- The ability to reduce symptoms and pain associated with
COVID-19.
- Ends-
Authorised for release by the board of directors, for further
information please contact:
MGC Pharmaceuticals Ltd MGC Pharmaceuticals Ltd
Roby Zomer Rowan Harland
CEO & Managing Director Company Secretary
+61 8 6555 2950 +61 8 6555 2950
info@mgcpharma.co.uk info@mgcpharma.co.uk
UK IR/PR Advisers UK Brokers
IFC Advisory Oberon Capital
Graham Herring / Tim Metcalfe / Aimee McCusker / Adam Pollock
Zach Cohen +44 203 179 5300
+44 203 934 6630 aimeemccusker@oberoninvestments.com
mgcpharma@investor-focus.co.uk adampollock@oberoninvestments.com
Capital Blossom Ltd
Arfan Afzal
info@capitalblossom.co.uk
www.capitalblossom.co.uk
About MGC Pharma
MGC Pharmaceuticals Ltd (LSE: MXC, ASX: MXC) is a prominent
European pharmaceutical company with a strong commitment to
creating accessible and ethically produced cutting-edge medicines.
Our approach combines in-house research with innovative
technologies, all aimed at discovering and producing treatments for
currently unmet medical conditions.
The company's founders and executives are distinguished figures
in the global pharmaceutical industry. Our central business
strategy revolves around the development and supply of innovative
medicines, responding to the increasing demand in the medical
markets of Europe, North America, and Australasia.
MGC Pharma maintains a robust development pipeline that
addresses two prevalent medical conditions, with additional
products currently in the developmental stages. We've established
strategic partnerships with renowned institutions and academia,
fostering the optimization of our medicines' development. These
medicines are produced in our EU-GMP Certified manufacturing
facilities, ensuring the highest quality standards.
With a growing patient base in key regions like the USA, UK,
Australia, and Ireland, MGC Pharma has also built a global
distribution network through a wide-reaching group of commercial
partners. This extensive network places us in a prime position to
supply the global market effectively.
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
Forward Looking Statements
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terminology. These forward-looking statements include matters that
are not facts. They include statements regarding the Directors'
beliefs or current expectations. By their nature, forward-looking
statements involve risk and uncertainty because they relate to
future events and circumstances. Investors should not place undue
reliance on forward-looking statements, which speak only as of the
date of this announcement.
[1] Refer to Announcement dated 15 December 2020
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END
NRADKLBFXLLEFBQ
(END) Dow Jones Newswires
December 19, 2023 02:57 ET (07:57 GMT)
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