AXIM® Biotechnologies, Inc. (AXIM® Biotech) (OTC: AXIM), a world leader in cannabinoid research and development, today announced that the company’s product development partner Quay Pharmaceuticals Ltd. (“Quay Pharm”) has obtained the relevant licenses from the British Home Office to import and work with the controlled drugs that are required to continue the development of AXIM MedChew Rx® pharmaceutical chewing gum’s family of products.
MedChew Rx – formulated with 5 mg of cannabidiol (CBD) and 5 mg of tetrahydrocannabinol (THC) – is being developed as a pharmaceutical drug to treat pain and spasticity associated with multiple sclerosis (MS).
According to research firm GlobalData, the value of the MS treatment market is estimated to reach $20 billion by 2024, primarily driven by the continued development of new products and an increase in diagnosis rates across major markets including US, France, Germany, Italy, Spain, the UK, Japan, Canada, China and India.
To develop and produce MedChew Rx family of chewing gums, AXIM Biotech works with its partners to procure cannabis strains, extract and purify the strains into pharmaceutical-grade cannabinoids, develop and produce the cannabinoid-containing chewing gum products and afterwards undertake clinical trials. All processes are based on AXIM’s proprietary IPs.
Specifically, AXIM Biotech procures cannabinoid strains from the Dutch Government’s Office of Medicinal Cannabis (OMC), which is produced by Bedrocan BV at the world’s only GMP-certified facility for pharmaceutical grade cannabis. AXIM Biotech has co developed patented extraction and purification methods for 99.9% purity pharmaceutical-grade cannabinoids with Syncom BV.
The multilayer pharmaceutical chewing gum is developed by Quay Pharma in Great Britain.
“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,” commented Maireadh Pedersen, Chief Executive Officer of Quay Pharma.
Xendo B.V. is handling regulatory affairs, and QPS is an international clinical research organization in charge of managing the entire project including the clinical strategy and trials.
“We are excited to move forward the development of MedChew Rx pharmaceutical chewing gum with our world-class research and product development partners,” said George E. Anastassov, MD, DDS, MBA and Chief Executive Officer of AXIM Biotech. “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 an efficacy Phase 2A clinical trials at the Free University in Amsterdam, and subsequently move onto a Phase 3 clinical trials in Vrije Universiteit Amsterdam, the UK and USA. We anticipate to complete Phase 3 clinical trials in early 2018.”
AXIM® Biotechnologies, Inc. (OTC: AXIM) focuses on the research, development and production of cannabis-based pharmaceutical, nutraceutical and cosmetic products. Our flagship products include CanChew®, a CBD-based controlled release chewing gum, and MedChew Rx, a combination CBD/THC gum that is undergoing clinical trials for the treatment of pain and spasticity associated with multiple sclerosis. We prioritize the well-being of our customers while embracing a solid fiscal strategy. For more information, please visit www.AXIMBiotech.com.