New Zealand’s largest licenced medicinal cannabis company, Helius Therapeutics, has been issued with the industry’s first GMP (Good Manufacturing Practice) Licence to Manufacture Medicines by MedSafe. It allows the company to begin manufacturing locally made medicines for New Zealand patients.
“This is our most significant milestone yet at Helius. The GMP Licence means Helius can now move forward to manufacturing high-quality, affordable Kiwi-made medicinal cannabis products. New Zealand doctors will be able to confidently prescribe in the knowledge that Helius meets stringent quality standards,” says Carmen Doran, Chief Executive of Helius Therapeutics.
Based in Auckland’s East Tamaki, Helius began the rigorous and complex journey for the GMP Licence as a start-up in 2018. Through an international recognition scheme, MedSafe’s latest approval also meets European standards, known as EU-GMP, opening future export possibilities for the 100% privately-owned Kiwi company.
By achieving the GMP Licence to Manufacture Medicines, Helius joins the likes of Douglas Pharmaceuticals. As well as being the first from the medicinal cannabis industry, Helius becomes only the 20th on Medsafe’s list of organisations licenced to produce medicine in New Zealand.
“The GMP licencing process has been exhaustive, and rightly so. We’re making medicines, so there is no room for cutting corners. Helius pulled together an internationally- experienced leadership team from both the pharmaceutical and medicinal cannabis industries to successfully achieve this level of compliance,” she says.
Ms Doran herself is no stranger to the world of pharmaceutical manufacturing. She worked globally with Novartis Pharmaceuticals for 10 years before consulting in the same area, particularly in start-ups and new technology, for the last five years.
Having raised $48m in capital since 2018, Helius has invested significantly in its 8,800sqm indoor cannabis cultivation and manufacturing complex. New Zealand’s largest purpose-built facilities are designed to achieve precision-controlled cannabis cultivation, extraction, purification, product manufacturing and analytical testing.
“We’ve been pushing hard to build the facilities, procedures and systems that will ensure quality. Ultimately, that is what GMP is about – controlling all the factors that could influence the quality of our processes, so we know that patients will get exactly what their doctor prescribed, every time,” says Bruce Wallace, Chief Quality Officer at Helius Therapeutics.
Mr Wallace joined Helius at the beginning of 2020 and has been instrumental in guiding the team through setting up the processes needed to bring medicines to market. He brings 25 years of pharmaceutical experience in both human and animal health having previously worked for Merck in the USA. More recently he was Global Head of Quality for Argenta Manufacturing based here in New Zealand.
Mr Wallace says the GMP Licence certification covers a wide scope from facility design to the training of people. MedSafe assessed and approved the company’s manufacturing, packaging, labelling, testing, storage and distribution processes. Over time, the GMP Licence to Manufacture Medicines will expand to include other product types and other parts of the value chain.
As a newly licenced company in a new industry, Helius can expect routine GMP audits to ensure its high standards are maintained. As it adds additional manufacturing capabilities to its licence, each new manufacturing process type will trigger a new audit.
Mr Wallace says ongoing audits are positive for all involved.
“Having experienced, professional inspectors, such as the Medsafe GMP team, challenging your systems can only improve your processes and outcomes,” he says.
While Helius now has the necessary GMP Licence to Manufacture Medicines, products will also need to meet quality standards set by New Zealand’s Medicinal Cannabis Agency to establish safety, stability, and efficacy via the Product Registration process.
“The final step for us in being able to supply medicines is providing the Medicinal Cannabis Agency with data and evidence to demonstrate these products meet the required standards. That’s not easy, but absolutely necessary to ensure products are safe and effective. Helius views this as non-negotiable and in line with bringing other medicines to market. We are, after all, talking about medicines for people and their loved ones,” says Mr Wallace.
Ms Doran agrees that patients and doctors need the utmost confidence that medicinal cannabis products prescribed are of uncompromising quality and safety.
“The Helius team has reviewed regulations and requirements for medicinal cannabis products in several major export markets. We can confidently say New Zealand’s standards are equivalent or higher than those overseas, and that’s a good thing,” she says.
As a leader in New Zealand’s newest industry, Helius acknowledges recent commentary that the country’s medicinal cannabis regulations are too hard and it’s taking too long for locally-made products to be approved.
“We totally get it. There’s no time to rest until New Zealand patients have more treatment options. However, no one is dragging the chain here. Despite being a botanical product, it’s worth remembering that medicines typically take five to 10 years to develop and approve – and we are well ahead of that.
“In fact, we believe patients will have access to Kiwi-made products from later this year. All of us at Helius Therapeutics, MedSafe, the Medicinal Cannabis Agency, and the wider industry are working incredibly hard to make that happen,” she says.
Carmen Doran says Helius has built the team and facilities to get the job done, motivated by an unwavering commitment to improve patients’ quality of life.
“The GMP Licence to Manufacture Medicines is the pivotal moment in being able to bring the first products to market. We are excited about these products as well as the novel therapeutics in the pipeline to come.
“It has been a tremendous effort from our founders, investors, and team to turn a vision into what is now a fully-fledged medicines production company. Being New Zealand’s first medicinal cannabis business to gain GMP certification and Licence to Manufacture Medicines is a huge win for Helius and we’re all incredibly proud,” she says.