Axim Biotechnologies already uses cannabinoids in its nutraceutical chewing gum CanChew and is now looking to use similar ingredients and technology to bring the first “medical marijuana” product delivered by gum to market.
CanChew contains cannabidiol (CBD), a non-psychotropic cannabinoid, but the pharma candidate MedChew also contains tetrahydrocannabinol (THC) the principal psychoactive constituent in cannabis, Axim’s CEO George Anastassov explained.
“Clinical trials are underway in Amsterdam on patients with chronic pain from Multiple Sclerosis and we anticipate this will be registered with the [US] FDA and EMA within the next two years,” he told this publication.
“We are also starting clinical trials with cannabinoids for inflamatory bowel disease, irritable bowel disease and Crohn's disease disease.”
The trials are being carried out by Netherlands-headquartered contract research organisation (CRO) Syncom.
Chewing the bud
Axim’s Chief Technology Officer, Lekhram Changoer, added MedChew’s technology was similar to that used in nicotine gum, and offers a slow release of the API while avoiding the gastro-intestinal (GI) tract.
“Once cannabinoids enter the GI tract they are destroyed by the hepatic mechanism so we are trying to avoid this by having direct delivery into the microcirculation via the oral mucosa,” he explained. “It is a slow release with the cannabinoids being released within approximately 20 minutes.”
GW Pharma’s cannabinoid product Sativex is already approved in a number of European countries, but is alcohol-based and delivered through an oromucosal spray which Changoer said could be problematic for some patients.
Own supply
As the company targets a launch date of 2017 – clinical trial data permitting – attention has turned to supply, and Axim has announced it is buying 5,000m2 of land in Almere, The Netherlands, to construct its own manufacturing facility for all its pharmaceutical, neutraceutical and cosmetic products.
“We get the raw materials from Bedrocan [a marijuana and hemp growing facility under supervision of the Dutch Ministry of Health] as they have a GMP agricultural facility so the quality is highly qualified to make pharma products,” said Changoer, adding the extraction of the cannabinoids and formulation will occur at the new site.
Currently the firm uses Danish contract manufacturer Fertin Pharma for clinical supplies of the finished product, Anastassov revealed, as while “there are many chewing gum manufacturers over the world, there are few manufacturers working under [required] GMP.”
Fertin will remain a partner once Axim’s facility is constructed in order to ensure supply chain security, Anastassov confirmed, by having multiple manufacturing locations for the product.