Nanaimo-headquartered Tilay announced it will export medical marijuana to patients in Chile, Brazil and New Zealand this week also confirming it has started supplying product candidates to trial sites in Canada and Australia.
Tilray is familiar with the rules covering the shipment of medical marijuana in Canada. However, the differing regulations covering distribution and use of such products in the new markets required additional research, according to CEO Brendan Kennedy.
Kennedy told us: “It depends on the location. If it's a whole plant extract, in some countries that's easier to get through the regulatory approval process. We look at it more as a biopharmaceutical product.”
He cited New Zealand as an example, explaining that the country’s laws permit patients to access medical cannabis products with special authorization from the Ministry of Health.
Exporting for trials
One of Tilray’s trials is testing the safety and tolerability of its cannabis-based drug TIL-TC150 in children with Dravet Syndrome, a severe form of drug-resistant epilepsy, at the Toronto Hospital for Sick Children in Canada.
The firm is also testing various capsule-based and vaporized formulations for chemotherapy induced nausea and PTSD in studies in Australian and Canada, respectively.
Kennedy: “The patient numbers overall are lower than we imagined in Canada, and they're certainly lower than Health Canada's own projections. [That] certainly incentivized us to look at other potential markets for this product."
This month Tilray also partnered with Alef Biotechnology SpA, to work alongside the Chilean regulators to help distribute the firm’s products for clinical use in Chile and Brazil.
Kennedy told us: “Alef is navigating the regulatory framework in Chile alongside the government there. We have already produced formulations for them, ready for distribution into July.”
Tilray’s Director of Clinical Research joined the team from working on GW Pharmaceutical’s investigational new drug (IND) application for its lead product, CBD based Epidiolex, for paediatric epilepsy.
However, Kennedy told us firms such as UK-based GW Pharmaceuticals are more of a traditional pharma business in its clinical trial process: “I would describe them as a pharma development company that happens to base their formulations on CBDs.”
Additionally, Joashua Eades, CSO of Tilray, explained that although both Tilray’s oral solution for Dravet’s syndrome and GW Pharmaceutical’s Epidiolex both contain cannabidiol, there is a difference in concentration of APIs.
A dropper is used to deliver the oral formulation to paediatric patients, which contains tetrahydrocannabinol (THC) and cannabidiol (CBD) from the Cannabis sativa plant.
Export of liquid capsules containing up to 5.0mg of each of these active pharmaceutical ingredients were also approved for export to Croatia by Health Canada last year.
However, Eades told us because Tilray submitted the formulation as a drug master file to the Health Canada at the end of last year, “the exact formulation remains confidential until it is approved”.
“Tilray, in fact, is the only GMP certified producer of whole flower cannabis products - oils, extracts and other formulations - in the world. That's our main point of our differentiation,” Kennedy concluded.