"This is great news for many patients who have long sought legal access to both New Zealand-grown and made medicinal cannabis products," says Carmen Doran, chief executive of Helius Therapeutics.
Her comments follow Helius being the first New Zealand medicinal cannabis company to gain approval for products derived from locally grown cannabis plants, with the Full Spectrum CBD medicines also locally extracted and manufactured.
On 13 September, the Medicinal Cannabis Agency publicly advised that both Helius CBD25 Full Spectrum and Helius CBD100 Full Spectrum products had been verified as meeting the quality standard – a requirement under the 2019 regulations before producers can supply the New Zealand market.
The latest products are first being launched in New Zealand and then will be exported around the world, with Europe and South America as priority markets.
With exciting prospects on the horizon for New Zealand's leading and largest medicinal cannabis company, Ms. Doran says Helius is now actively seeking investment to accelerate its domestic and international growth plans.
"Gaining approval of medicinal cannabis products that are truly New Zealand-grown and made is a significant milestone for our industry and another first for Helius. Local patients and their advocates have fought long and hard for truly Kiwi products which are both high quality and cost-effective," says Ms. Doran.
News of its latest CBD products receiving approval for distribution follows Helius gaining verification of its active ingredient meeting the quality standard on 30 August. Ms. Doran says the Medicinal Cannabis Agency's product approval will undoubtedly help address access issues for Kiwi patients.
"We have seen significant delays and disruptions in the availability of imported products as Covid continues to impact supply chains. It is disconcerting for patients and prescribers when products that are making a difference in people's lives are not available. Fully New Zealand-grown and made products will help alleviate such issues," she says.
The newly approved medicines have been developed at Helius' manufacturing site in East Auckland. Cannabinoids - the active compounds in the cannabis plant – have been extracted from dried flowers grown by New Zealand's largest and only organic certified medicinal cannabis cultivator, Puro.
At the start of this year, Helius signed a multi-million-dollar five-year supply deal with South Island-based Puro. In April, Helius' license was then renewed and expanded by the regulator, enabling it to make active ingredients onsite from raw cannabis material which achieved verification last month.
Helius was New Zealand's first medicinal cannabis business to achieve a GMP Licence for Manufacturing Medicines in July 2021, covering the first products to market three months later.
Every New Zealand GP can prescribe medicinal cannabis for any health condition, with Kiwi-manufactured products using imported active ingredients available since October last year.
While more Kiwis are now getting a doctor's prescription for medicinal cannabis products, Helius says bringing the supply chain home delivers on the country's goal of enabling a local industry to supply local products to local patients.
"In 2018, Parliament's legislative intent around improving access and affordability was clear. The subsequent Medicinal Cannabis Scheme has also strived for both locally grown and made cannabis medicines. That national ambition to better serve long-suffering Kiwi patients is finally a reality, and that's exciting," says Carmen Doran.
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