- MGC Pharmaceuticals (MXC) receives a permit to import its proposed COVID-19 treatment into India for emergency use drug registration
- CimetrA, is a phytomedicine currently progressing through a phase 3 clinical trial in Israel, following the completion of phase two trials in 2020
- The permit will facilitate the company’s final product testing and, if successful, the permit will be made permanent once approved as a medicine in India
- In anticipation of increased demand for the treatment, MXC has secured agreements for two additional production facilities
- Shares have been trading 12.8 per cent higher at 5.3 cents at 12:40 am AEST
MGC Pharmaceuticals (MXC) has been granted a permit to import its proposed COVID-19 treatment into India for emergency use drug registration
The company’s product, CimetrA, is a phytomedicine, meaning it is a herbal medicine with therapeutic properties and is currently progressing through a phase 3 clinical trial in Israel, following the completion of phase two trials in 2020.
Through preclinical and clinical testing, MXC said the drug had been shown to be effective in the prevention of severe inflammation by controlling increased cytokine production. This has been found in different variants and mutations of COVID‐19 and is the forerunner of ‘cytokine storm’ which is believed to be the main reason for mortality in severe COVID‐19 patients.
As India has been acutely affected by the pandemic, the company believes its treatment can make an important difference in treating the symptoms of COVID-19.
The import permit has been granted by India’s Central Drugs Standard Control Organisation and will assist MXC in obtaining emergency use authorisation.
This authorisation allows local regulators to strengthen public health measures during health emergencies – in particular the COVID-19 pandemic.
In the quest for authorisation, the company needs to submit final samples for testing and analysis.
If these tests are successful, the temporary permit will be converted to a permanent approval once the treatment has been registered as an approved medicine in India.
Co‐founder and Managing Director of MGC Pharma Roby Zomer said the company hoped it could secure approval swiftly to expand its availability to a much wider patient base.
The process is expected to take 90 days from the import of the CimetrA samples into India.
Medopharm, manufacturer and exporter of pharmaceutical products in India, is managing the authorisation process for CimetrA in India on MGC Pharma’s behalf.
Mr Zomer said this was important given Medopharm’s experience of taking
medicinal products through the process to full approval for sale.
In anticipation of increased demand for the treatment, MXC has secured agreements with two additional facilities to manufacture large quantities of the treatment until its Malta production facility completes its commissioning and is fully operational in 2022.
Shares were trading 12.8 per cent higher at 5.3 cents at 12:40 am AEST.