Quay Pharmaceuticals receives permission to advance MedChew chewing gum development

The British Home Office has awarded relevant licences to Quay Pharmaceuticals, the product development partner of Axim Biotechnologies, to move forward with the development of Axim’s MedChew Rx pharmaceutical chewing gum’s family of products.

The permit will allow Quay Pharma to import and work with the controlled drugs that are necessary to continue the development of MedChew Rx products.

MedChew Rx is a formulation of 5mg of cannabidiol (CBD) and 5mg of tetrahydrocannabinol (THC) currently being developed to treat pain and spasticity associated with multiple sclerosis (MS). It is developed by Quay Pharma in Great Britain.

Quay Pharma CEO Maireadh Pedersen said: "It is a very exciting development process we have embarked on with Axim and we are delighted to be supporting them on their range of projects.

"The development of the Med Chew RX gum will be carefully formulated to ensure that the drugs are preferentially absorbed orally within a specific window of time to provide the best therapeutic outcome for the patients."

Axim Biotech procures cannabis strains for the development of MedChew Rx family of chewing gums from the Dutch Government’s Office of Medicinal Cannabis (OMC).

The strains are produced by Bedrocan at the world’s only GMP-certified facility for pharmaceutical-grade cannabis.

"For now, we are focusing on the prototypes of MedChew chewing gums and ensuring our products comply with all FDA / EMA regulations."

Working along with its partners, Axim Biotech uses its patented extraction and purification methods for 99.9% purity pharmaceutical-grade cannabinoids, which were co-developed with Syncom.

The cannabinoid-containing chewing gum products that are developed, produced and evaluated by undertaking clinical trials.

Axim Biotech CEO George Anastassov said: "For now, we are focusing on the prototypes of MedChew chewing gums and ensuring our products comply with all FDA / EMA regulations.

"After achieving product stability, we will start efficacy Phase IIA clinical trials at the Free University in Amsterdam, and subsequently move into a Phase III clinical trials in Vrije Universiteit Amsterdam, the UK and US.

"We anticipate completing the Phase III clinical trials in early 2018."

Xendo is handling the product's regulatory affairs, while QPS holds the responsibility to manage the entire project, including clinical strategy and trials.

Research firm GlobalData estimates that the value of the MS treatment market will touch $20bn by 2024, driven by the development of new products and increase in diagnosis rates across major markets.