CEO Rob Mitchell, with Rua Bioscience’s first GMP certified product. (Image/Rua Bioscience)
Rua Bioscience, New Zealand’s first Māori founded NZX-listed company, got its best news for the year this week when it received Good Manufacturing Practice (GMP) certification from Medsafe, which means it can start manufacturing its first medicinal cannabis product, a cannabinoid (CBD) oil.
It is only the second company to receive that certification (privately owned Helius Therapeutics was certified recently), which is the global standard for all pharmaceuticals. GMP is a prerequisite for both domestic and export sales.
It comes after a tough year for the company, originally founded in 2016 as a subsidiary of Hikurangi Enterprises, which aims to create economic opportunities for the local community.
Based in Ruatoria on the East Coast, Rua Bioscience listed on the NZX last October at 70c a share but the price has since dropped to 41c.
The shares of its listed rival, CannaSouth, also dropped, with market commentators saying the strict New Zealand regulations, lack of local labs to test products and Covid-19's slowing down of global mail had hindered the new industry's progress.
After this morning’s NZX announcement Rua BioScience’s share price began a slight rise.
First big tick
Rua Bioscience CEO Rob Mitchell says certification is a significant milestone for the Tairāwhiti-based pharmaceutical company.
“Gaining certification just 12 months after commissioning our facilities and listing on the NZX is a massive achievement, and a testament to the great work being done here in Tairāwhiti by a highly-experienced, talented and tenacious team,” he says.
“Put simply, GMP certification means we've moved a long way down the path to being allowed to manufacture products. The next stage is to submit a New Medicinal Cannabis Product Application to the Medicinal Cannabis Agency, which will undertake an assessment against the Minimum Quality Standards.
"While it is unclear how long the application review process will take, we anticipate being able to supply product for the domestic market by early 2022. Manufacturing will take place at our purpose-built facility in Gisborne and the compounded CBD oil will be available in New Zealand as a prescription only medicine.
“Achieving GMP certification means many of the common processes that will be required for the production of dried cannabis flower have also been reviewed. Rua Bioscience has a New Zealand exclusive contract for supply for German pharmaceutical distribution partner, Nimbus Health, so we will be able to start fulfilling those orders as soon as dried flower products have been through similar approval processes,” he says.
Rua’s certification comes after a series of challenging external delays. Chief operations officer Paul Naske views the process as an invaluable learning opportunity that will ultimately hold the company in good stead as further products are brought to market.
“While the process has been challenging at times, we were always confident in our people, processes and of a positive outcome.
“It’s important to remember that, at this point, the New Zealand industry is heavily reliant on overseas laboratories for critical pieces of the GMP puzzle. But this is temporary – as the industry develops, so too will New Zealand-based ancillary services, which will streamline industry practice,” he says.
Since the implementation of the Medicinal Cannabis Scheme, Rua has focused on meeting heightened global demand for medicinal cannabis products through the establishment of world class cultivation and manufacturing capabilities in Tairawhiti.
Data released by the Ministry of Health under the Official Information Act shows the number of packs of medicinal cannabis prescribed and supplied in New Zealand is growing at an average rate of 250 per cent annually. The number of packs supplied in New Zealand in the year to June 30, 2021 was over 31,000; compared to just 2,000 in 2018.
This growth is in spite of patients’ ability to access medicinal cannabis being constrained by a lack of available products, limited prescriber understanding of the clinical benefits of medicinal cannabis and the absence of government subsidies. According to a study published in the British Journal of General Practice, CBD oils are commonly prescribed in New Zealand for pain, epilepsy and anxiety.