The country’s largest medicinal cannabis company has announced another New Zealand first. The Ministry of Health has awarded Helius Therapeutics GMP (Good Manufacturing Practice) certification for the drying and finishing of medicinal cannabis flowers.
“This latest certificate moves us closer to delivering New Zealand-grown flowers to market. In fact, we’re hoping to have it available for local patients later this year,” said Helius Therapeutics chief executive, Carmen Doran.
Further afield, Helius is on track to be a global leader in the production and export of quality cannabis flowers, with signed contracts for Helius flowers already in place.
Locally, there are 13 dried flower products - for inhalation and tea - currently being imported into New Zealand with clinics reporting massive supply chain reliability issues, creating headaches for doctors and patients alike.
“This certification is a very significant development for Helius and our country’s newest sector. It’s also great news for the many patients and advocates who fought for years for the legalisation of a local medicinal cannabis industry to produce 100% local products for local people,” she says.
Such key site-wide certification will see the East Tamaki-based significantly boosting its indoor growing operations, with Kiwi-grown flowers available to Kiwi patients via a doctor’s prescription adding to the oil extract products already available to patients.
Helius currently supplies the domestic market with six oil-based medicinal cannabis products, with the active ingredient being extracted from biomass organically grown by Puro – a leading South Island-based cannabis cultivator - or grown at the Helius facility.
Being the only company in New Zealand to now be fully certified across its entire facility will allow Helius to further expand its product portfolio.
“Site-wide certification including dry flower will only improve the reliability of the local supply chain and improve the local offering,” said Doran.
The CEO said once medicinal cannabis flower is in the market, Helius will be among just a few medicinal cannabis companies in the world that are truly fully vertically integrated and EU-GMP recognised, opening up access to European and Australian markets.
GMP certification for the drying and finishing of cannabis flower follows nearly two years of Helius meeting regulatory milestones and high levels of compliance after achieving its first GMP licence in July 2021.
Since being the first medicinal cannabis company in New Zealand to achieve a GMP Licence to Manufacture Medicines, the 100% Kiwi-owned private company has consistently added more GMP processes to that list. These cover the extraction of CBD and THC crude and distillate, manufacture of cannabis-based medicines, drying and processing of dried flowers, and packing and distribution of medicinal cannabis products.
Late last year Helius became the first local company to receive GMP certification to produce THC extracts and manufacture medicines containing THC. This enables them to produce THC-containing medicines that are both grown and made in New Zealand.
“Yes, we’ll soon be a ‘seed to sale’ company, but we see our vertical integration operation more through the lens of ‘plant to patient,” she said.
Driven by improving Kiwi patients’ quality of life, Helius began the rigorous and complex journey for GMP certification as a start-up in 2018.
“This latest announcement is a testament to the culture of teamwork and excellence Helius is building. It reinforces our technical prowess not to mention our highly controlled, precision indoor growing environment which will deliver consistent all-year-round results,” she said.
She says Helius’ GMP compliance has taken an internationally experienced leadership team as well as a commitment to work alongside the regulators with patient safety and product quality at the fore.
“It was Helius who first ensured New Zealand patients had access to locally made products across the spectrum of oral solutions. And it will soon be Helius that ensures local patients won’t have to rely on the imported flower as their only legal means of obtaining it,” said Carmen Doran.
Helius’ operations connect cultivar breeding to yield optimisation; precision extraction of high-value cannabinoids, next-generation medicine development, GMP production, plus academic and several scientific partnerships.
Last year Helius raised $13m in capital from committed New Zealand investors, reinforcing its steadfastness and product dominance in the local market. This year the company will unleash its export strategy. More GMP certificates and manufacturing milestones will follow.
