MGC Pharma’s lead product CimetrA one step closer to a registered medicine for COVID-19 patients in India
Health & Biotech
Health & Biotech
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MGC Pharma has been given the green light to import its lead product CimetrA into India in a crucial step to being granted Emergency Use Authorisation to be registered as a medicine for treatment of COVID-19 patients.
European-based biopharma company MGC Pharma (ASX:MXC) has been granted import approval into India for its phytomedicine CimetrA as it moves toward obtaining Emergency Use Authorisation for treatment of COVID-19 patients.
As India continues to grapple with thousands of new COVID-19 infections and hundreds of deaths daily, Indian authorities granted the permit, which will enable MGC Pharma to submit final samples of CimetrA for the last stage of testing to be granted Emergency Use Authorisation.
If the tests are successful the approval will be converted to permanent once CimetrA has been registered as a medicine under the Emergency Use Authorisation Protocols. The final testing process is expected to take up to 90 days from the import of the samples.
Leading Indian pharmaceutical manufacturer Medopharm has been appointed to import and market CimetrA in India.
The company has more than 50 years of experience in developing and licensing medicinal products and will manage the marketing authorisation approval process for CimetrA in India.
CimetrA has anti-inflammatory and immuno-modulating effects, based on Curcumin and Boswellia Serrata as anti-inflammatory agents, which are well-known natural active ingredients with immunomodulatory properties.
Preclinical and clinical results to date have demonstrated CimetrA as an anti-inflammatory and immunomodulatory agent effective in the prevention of severe inflammation by controlling increased cytokine production, found in different variants and mutations of COVID-19.
Increased cytokine production is the forerunner of cytokine storm, which is believed to be a main reason for deaths in patients with severe COVID-19 disease.
CimetrA is undergoing a Phase III clinical trial in Israel as an Investigational Medicinal Product for the treatment of COVID-19 following successful Phase II trials in 2020. The first patient was enrolled in the trial in July 2021.
MGC Pharma co-founder and managing director Roby Zomer said he was hopeful CimetrA would soon be given Emergency Use approval as a medicine to treat a much wider patient base in India.
He said to meet the potential significant increase in demand for the therapy MGC had secured agreements with two additional EU GMP certified production facilities. He said these facilities could be used to manufacture large quantities of CimetrA until its Malta production facility is commissioned and fully operational in 2022.
“India has been acutely affected by the COVID-19 pandemic and we believe that CimetrA can make an important difference in treating the symptoms of COVID-19 and alleviate patient suffering,” Zomer said.
“It is important that we have secured Medopharm as the importer and the marketing authorisation holder of CimetrA, given their vast experience of taking medicinal products through the process to full approval for sale.”
It’s been a good couple of weeks for MGC Pharma, which has struck a multi-million production and supply deal with AMC Holdings to supply pharmaceutical products to the US.
AMC is headed by senior executives with vast Capitol Hill legislature, regulatory and health care sector experience, including CEO Brett Scott, a former legal trial attorney in the Tax Division and a Senior trial attorney in the US Justice Department’s Civil Division.
DEA’s Lifetime Achievement Award winner, Tampa attorney James Cusack, as well as former US Attorney, Bobby O’Neill, are on the board.
O’Neill once headed the Justice Department’s Narcotic and Dangerous Drug Section.
The first dedicated agreement by MGC in the US covers all three of its lead products, CannEpil, CogniCann and CimetrA, and obliges AMC to make minimum purchase orders of US$24m over a three-year period.
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.