Under the good manufacturing practice (GMP) license, Axim Biotechnologies will commence production of its lead candidate, MedChew Rx, for use in human studies.
MedChew Rx is a controlled-release gum delivery system containing 5mg delta-9-tetrahydrocannabinol (THC) and 5mg cannabidiol (CBD), designed to treat pain and spasticity in patients with multiple sclerosis.
According to CEO George Anastassov, the GMP certification sets Axim Biotech apart in the pharmaceutical cannabinoid space.
There is just one GMP-certified cannabis production plant in the world, said Anastassov, referring to Dutch pharmaceutical-grade cannabis supplier – and Axim Biotech partner – Bedrocan BV.
This latest certification may well make Axim Biotech, “the only player in the space with products which are GMP from start to finish. For us, it’s important to close the circle, from start to finish – for everything to be GMP,” he told us.
Looking ahead to commercialisation, the firm said it would require a manufacturing facility to eventually market its products in the US and Europe.
“At this point, we will have to build one in the Netherlands, or we will be reliant on third-party manufacturing,” said Anastassov, confirming that the plan is to manufacture in-house.
The company would then simultaneously target the two largest markets, submitting regulatory approval applications to the FDA and European Medicines Agency, we were told.
“But of course we will look for registration in other markets, as well – for example, in South America and Asia.”
Purer than Epidiolex?
Axim Biotech’s patented methods, granted by the US Patent and Trademark Office in June this year, produce ‘nearly pure molecules’ – purer than GW Pharmaceuticals’ Epidiolex, according to Anastassov.
Epidiolex was the first cannabis-derived pharmaceutical product to receive US Food and Drug Administration (FDA) approval in June this year, for the treatment of two forms of epilepsy.
“If I’m not mistaken, GW Pharmaceuticals’ Epidiolex has a purity of 95%. Our product is 99.9% pure.
“It’s just as pure as synthetic, if you will, but it’s from naturally extracted sources. Therefore, I don’t think we will have much trouble with the FDA and the Drug Enforcement Agency or The Netherlands’ Medicines Evaluation Board,” said Anastassov.