Rua Bioscience, the Tairāwhiti-based medicinal cannabis listed company, has received verification that its first medicinal cannabis product meets the NZ Medicinal Cannabis Agency’s (Medsafe’s) quality standards, enabling the company to distribute its first medicine in New Zealand.
The approval of the product means New Zealand patients and prescribers can include the Rua product in their treatment plan. Rua intends to distribute product by the end of the first quarter to early the early second quarter of 2022.
It will be made available as a prescription-only medicine through GPs and specialists.
Rua will manufacture the medicine in its purpose-built facility in Gisborne, having gained Good Manufacturing Practice (GMP) certification for the product earlier this year.
Rua Bioscience chief executive Rob Mitchell says this positions the company well as it enters a new chapter of sharpened focus in bringing product to market and creating sustainable revenue.
Laying the foundations
“In the past two years we’ve laid the foundations for commercialisation. We built cultivation and manufacturing facilities in Tairāwhiti, listed on the NZX and hired both local and international expertise to help us realise our vision of becoming an industry-leading pharmaceutical company.
"With this approval, we start the revenue generation phase of our company’s journey and deliver against our commercial imperatives in 2022."
Further expanding on patient choice and accelerating market entry, Rua recently announced the proposed acquisition of Zalm Therapeutics, which shareholders will be asked to vote on in January. The deal will enable Rua to supply New Zealand patients and global markets with a range of Australian-grown oil and dried flower products in the short term and product grown from unique Ruatorea-developed genetics in the longer term.
"Our commercial strategy recognises the need to diversify revenue, accelerate market entry and expand patient choice," Rua Bioscience chief commercial officer Dr Andrea Grant says.
Fyfe connection
"While New Zealand may be a small market, it is growing rapidly. Patients and clinicians are relying on the local industry to provide them with brand and product choice to address their unmet health needs. This is a crucial step for Rua in meeting those needs.
“Next year will be all about going wider, faster and earlier. We are fully focused on meeting the needs of patients, our community and our investors, who have been steadfast in their support.”
The company's share price rose four cents to 44c today after a decline over the past year.
The company, which was founded by local Māori, has seen its share base widen as it listed and, if its acquisition of Zalm Therapeutics goes ahead, the shareholders will include former Air New Zealand chief executive Rob Fyfe, who chairs Zalm.
A virtual-only meeting to discuss that takeover and share swap will be held at https://meetnow.global/nz at 12:00 noon on January 19, 2022. Rua Bioscience has entered into an agreement to acquire 100% of Zalm Therapeutics, a New Zealand-based medicinal cannabis company, which has Australia's leading listed medicinal cannabis company, Cann Group as one of its key shareholders.