RCS - MGC Pharmaceuticals - ArtemiC™ receives FDA Approval in Saudi Arabia

Argent BioPharma

19/12/2023 07:57

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RNS Number : 2920X  MGC Pharmaceuticals Limited  19 December 2023

 

MGC Pharmaceuticals Ltd.

ArtemiC™ 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™ 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™ 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™ 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™

ArtemiC™ is a clinically tested product. Developed by MGC Pharma, it
incorporates GraftBio® SNEDD technology, which increases the bioavailability
of ArtemiC™'s active ingredients.

In a Phase II double-blind, placebo-controlled Clinical Trial on 50 patients
with COVID-19, ArtemiC™ 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 (mailto:info@mgcpharma.co.uk)                       info@mgcpharma.co.uk (mailto:info@mgcpharma.co.uk)

 UK IR/PR Advisers                                                        UK Brokers

 IFC Advisory                                                             Oberon Capital

 Graham Herring / Tim Metcalfe / Zach Cohen                               Aimee McCusker / Adam Pollock

 +44 203 934 6630                                                         +44 203 179 5300

 mgcpharma@investor-focus.co.uk (mailto:mgcpharma@investor-focus.co.uk)   aimeemccusker@oberoninvestments.com
                                                                          (mailto:aimeemccusker@oberoninvestments.com) adampollock@oberoninvestments.com
                                                                          (mailto:adampollock@oberoninvestments.com)
 Capital Blossom Ltd

 Arfan Afzal

 info@capitalblossom.co.uk (mailto:info@capitalblossom.co.uk)

 www.capitalblossom.co.uk (http://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

This announcement may include statements that are, or may be deemed to be,
"forward-looking statements". These forward-looking statements can be
identified by the use of forward-looking terminology, including the terms
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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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