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When Helius Therapeutics recently gained a GMP (Good Manufacturing Practice) Licence to Manufacture Medicines, it signalled a major step forward for NZ’s nascent medicinal cannabis industry.
The licence allows the business to become the first in the country to start making medicinal cannabis products from its base in East Tamaki, Auckland. The MedSafe-approved licence is also mutually recognised as meeting EU-GMP standards, which means Helius will be able to export to Europe.
“Being the first in the industry to achieve a GMP Licence to Manufacture Medicines means that our focus firmly shifts to bringing our first medicines to market,” says Helius Therapeutics CEO Carmen Doran.
“We see this as a significant milestone for the industry, and for NZ patients.”
The Entourage Effect
NZ’s medicinal cannabis industry received the green light when the Medicinal Cannabis Scheme came into force in April 2020, enabling the manufacture and supply of local medicinal cannabis products.
However, to date, the only available products here that meet required quality standards are imported.
Working in such a new industry, says Doran, has required players to band together for momentum – something Helius calls the ‘entourage effect’.
“The entourage effect is something that comes from the world of cannabis itself. It describes the synergistic effect you get when the different cannabinoids – the active ingredients – in the plant work together to create a greater outcome than you would get from them individually.”
“This is actually one of our values, and it translates to this goal of collaboration – both within the business, and externally. If we work together the outcome is greater than if we worked in silos.”
Shifting the dial
Founded in 2018, Helius Therapeutics’ business spans medicinal cannabis cultivation, R&D, manufacturing, and commercialisation. The privately-owned Kiwi business has invested significantly in its indoor cannabis cultivation and manufacturing complex, which is designed to achieve precision-controlled cannabis cultivation, extraction, purification, product manufacturing, and analytical testing.
Callaghan Innovation support has helped establish cultivation, plant breeding, and medical research programmes at the business, which currently has a team of just over 20.
“We’ve recruited people with international experience and deep expertise – whether it’s in pharmaceutical manufacturing, cannabis research, or medical sales. Having such expertise allows us to interpret the new medicinal cannabis regulations, and work out the best ways to address them to bring innovative products to market,” says Doran.
Helius was one of a number of medicinal cannabis industry businesses that Callaghan Innovation drew on last year when developing the Medicinal Cannabis Capability Roadmap. The resource is one of three roadmaps designed to assist and guide businesses entering the hemp and medicinal cannabis industry, with the other two roadmaps covering hemp fibre and hemp seed.
In drawing up the roadmap, Callaghan Innovation Agritech Commercialisation Project Lead Andrew Cameron says around 75 industry participants were canvassed. Cameron says drawing on extensive US experience from the team at Helius helped identify particular areas of the value chain that could play to NZ’s strengths.
Collaboration on that project has also benefited Helius, says Doran: “The Medicinal Cannabis Capability Roadmap developed by Callaghan Innovation is a comprehensive document. It is a great tool for all of us starting out in the medicinal cannabis industry here in NZ.”
There have been around 1,000 total downloads of the roadmaps so far – the majority of which have been for the medicinal cannabis resource. That uptake, says Cameron, has been encouraging, and Callaghan Innovation is committed to continuing to keep the information current as the medicinal cannabis sector evolves.
Growing understanding
Helius is also helping grow the industry’s talent pipeline, recently bringing on three postgraduate students from AUT, two of which are supported by Callaghan Innovation Fellowship Grants. The students are being supervised by Dr Ali Seyfoddin, head of AUT’s Drug Delivery Research Group, and leader of NZ’s first postgraduate medicinal cannabis course, launched last year.
While medicinal cannabis industry regulations mean Helius is unable to discuss any detail about the focus of its R&D pipeline or products it’s developing, Doran says the students will be researching novel medicinal cannabis delivery mechanisms.
“Our work with AUT is all about lifting our R&D capability. The reality is for NZ to successfully compete on the world stage, we need to be a leader in the R&D space, particularly in medical and horticultural innovation.”
Regulatory restrictions also present broader challenges to commercialisation.
To help boost understanding, Helius sponsors online portal mcinfo.com, which provides medicinal cannabis information to prescribers and pharmacists, and the annual industry summit MedCan.
New industry, traditional strengths
Doran emphasises that although NZ’s medicinal cannabis industry is in its infancy, it draws on areas where NZ already excels – specifically combining high-value horticultural processes with technology and innovation.
For example, in early 2020 the business launched a research partnership with Biolumic – a Palmerston North-based agritech firm, which has also accessed Callaghan Innovation support, such as R&D Career and R&D Experience Grants, and funding for R&D projects.
Biolumic uses the power of UV light to improve plant performance, and Doran says experiments investigating increasing yield in commercial indoor cannabis cultivation using UV light treatments are showing promising results.
“Another nice example of the collaboration is that our Cultivation Manager, Ikaika Keli'iho'omalu, has been travelling to Biolumic to offer training on cannabis cultivation. So while they understand using UV light to grow plants, we’re helping them learn about growing cannabis. Hawaiian-born Ikaika is a third-generation grower, so what he doesn’t know about growing cannabis probably isn’t worth knowing.”
There’s certainly plenty of potential in the industry to pursue. It is one of the world’s fastest growing, with an annual compound growth rate of around 24% forecast to 2028.
“As a nascent industry, and one that’s also been seen to be on the fringe – although that’s changing – medicinal cannabis is a space that attracts early adopters,” says Doran. “It’s an exciting space to be in, with the coming months promising to be a game changer for NZ patients.”
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Updated: 12 July 2022