MGC Pharma has made further inroads into Europe, after receiving a regulatory approval in Germany for its nutraceutical food supplement, ArtemiC. Pic: Getty Images
Health & Biotech
In major milestones, MGC Pharma’s non-cannabis products ArtemiC and CimetrA got further boosts today in both Germany and India which will see the products being sold in more territories.
Europe-based biotech MGC Pharma (ASX:MXC) has made further inroads into Europe, after receiving a regulatory approval in Germany for its nutraceutical food supplement, ArtemiC.
The company has been issued a Free Trade Certificate by the German regulators, following the successful Phase2 trial in 2020 that demonstrated ArtemiC’s efficacy in expediting the clinical recovery of patients with mild COVID-19.
ArtemiC utilises Swiss Pharmacan’s patented MyCell technology, which is said to increase the bioavailability of the natural ingredients used in the formulation.
MGC Pharma has a master sales agreement with Swiss Pharmaca to distribute ArtemiC in Europe, with a minimum purchase order of 40,000 units per quarter.
The development today is the latest milestone in MXC’s European ambitions, where it was granted a landmark UK import permit for its epilepsy drug CannEpil+ just this week.
Meanwhile, a clinical trial conducted for ArtemiC’s cousin product, CimetrA, in India has also demonstrated efficacy against severe COVID-19.
The clinical trial showed a significant reduction in one of the main inflammatory markers related to COVID-19, C-reactive protein (CRP).
CRP is an acute inflammatory protein that increases up to 1,000-fold at sites of infection or inflammation. In COVID-19 patients, it is one of the main prognostic factors for deterioration in hospitalised patients.
The successful clinical trial follows the approval of CimetrA as an Emergency Use Authorisation granted by the Indian government announced two weeks ago.
ArtemiC is an important non-cannabis product range developed by MGC Pharma and Swiss Pharmacan.
The phyto-medicine formulation includes four natural-based ingredients consisting of curcumin, boswellia serrata, artemisinin and Vitamin C.
It also incorporates Swiss PharmaCan’s MyCell Enhanced delivery system technology.
MyCell claims to enhance the uptake of oil-loving molecules from the intestine, and improves the individual bioavailability of the oily components by 100-250-fold.
The issuing of the Free Trade Certificate in Germany, noted for its stringency of German food supplement approvals, is likely to significantly accelerate MGC Pharma’s entry into other markets, both within the EU and elsewhere.
“The issuance of a Free Trade Certificate for Artemi Rescue and the ArtemiC product line in Germany is a significant step forward for MGC Pharma as it opens the EU to the marketing and sale of one of the company’s leading products,” says Roby Zomer, co-founder and CEO of MGC Pharma.
“This is a major commercial milestone for both MGC Pharma and phytomedicines in general, as this approval serves to validate our clinical agenda, and research and development program.”
CimetrA meanwhile, is the pharmaceutical equivalent of ArtemiC (and also a palindrome).
The drug is in late clinical development, and is seeing active business development as a potential early-use product in a number of countries – with the US and India being the first two to sign up.
MXC says that both ArtemiC and CimetrA have anti-inflammatory properties.
As part of the Emergency Use Registration process for CimetrA as a medicine in India, an observational clinical trial was conducted using a nasal formulation.
This formulation was required to meet the physiological limitation of patients with severe cases of COVID-19.
The trial took place in Mahatma Gandhi Mission’s Medical College & Hospital, and studied 20 hospitalised patients, including 10 who were in need of an oxygen supply, with a further 10 on mechanical ventilation.
The finding, which showed high efficacy rates, was significant, and will expand the potential use of CimetrA and ArtemiC beyond COVID-19 and potentially into various other inflammatory indications.
“These latest observational trial results have expanded the possibilities for the use of ArtemiC and CimetrA, and their treatment of patients with severe COVID-19,” Zomer said.
“MGC Pharma has always placed the treatment of patients at the heart of everything we do, and these results are very promising signs for those who have been most severely impacted by the disease.”
This article was developed in collaboration with MGC Pharma, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
