The Therapeutic Goods Administration has issued a GMP licence for Cann Group’s Mildura facility in a move that will enable the company to manufacture medicine for distribution through the Special Access Scheme.
Cann said it will allow it to produce Active Pharmaceutical Ingredients (API), manufacture Satipharm capsules and perform in-house chemical, physical and microbiological tests to demonstrate products meet local and overseas regulatory requirements.
Cann chief executive Peter Crock said: “GMP licensing is the regulatory capstone of the Mildura facility, allowing us to cultivate, extract, manufacture, test and supply finished products entirely in-house.
“With the licence in place we can now add additional GMP capabilities in response to market demands.”
ASX-listed Cann had already received licences and permits from the Office of Drug Control.
Medlab Clinical has unveiled positive results from a University of South Australia study into the bioavailability of its Nanabis formulation.
Researchers at the university’s School of Pharmacy and Medical Sciences have found Nanabis has twice the bioavailability of an unnamed Australian Register of Therapeutic Goods-approved oral cannabis spray.
The research was conducted using a Population pharmacokinetics (PopPK) study, which examines the variability in drug concentrations within a patient population receiving clinically relevant doses of a drug of interest.
Nanabis uses a 1 to 1 ratio of THC and CBD enhanced by Medlab’s Nanocelle drug delivery technology. It has met primary and secondary endpoints in an advanced cancer pain trial at Sydney’s Royal North Shore Hospital and received Australian and UK ethics approvals for phase 3 trials.
Nanabis currently has two variants, a botanical construct available for compassionate use under the special access scheme and a fully characterised synthetic version which will be used in future clinical trials.
Medlab entered a trading halt on June 28, 2022 ahead of a capital raising.
Australian Natural Therapeutics Group
Australian Natural Therapeutics Group (ANTG) has launched a new medicinal cannabis oil grown and produced at its facility near Armidale, NSW.
Rocky Oil is a 30:1 THC to CBD mix for people suffering from conditions including chronic pain and insomnia.
Producer Northern Green Canada (NGC) has this week begun shipping its Shishkaberry cultivar to New Zealand firm Medleaf Therapeutics for immediate availability.
The flower product will be available from all major pharmacy wholesalers under the country’s new medicinal cannabis scheme.
NGC previously exported flower to New Zealand under the old regulatory regime, with an initial trial supply on a compassionate basis for several patients.
Medleaf director Courtney Letica said pricing is competitive with the illicit market, “delivering the next step on the path to affordability for Kiwi patients”.
The company has indicated interest in several cultivars from NGC to be commercialised later this year.
Ora Pharm has been awarded a Callaghan Innovation Grant to develop environmentally friendly technology for the cultivation of medicinal cannabis in New Zealand.
The company said creating a solution for growing under local conditions will mean fewer raw materials will need to be imported, reducing the impact on the environment, and ensuring consistent quality, potency and yield.
Meanwhile, it has signed a deal with US supplier Agrify to buy cultivation and extraction equipment in a deal with a base value of US$1.63 million.
In addition, Agrify will provide access to its seed-to-sale automation software for five years in exchange for monthly recurring SaaS (Software as a Service) fees.
Founder and CEO Zoe Reece said: “From the inception of Ora Pharm, I have placed a relentless focus on leveraging the most efficient and technologically advanced solutions to empower us to deliver premium industry products to our patients and global customers.”
Creso Pharma’s wholly-owned Canadian subsidiary Mernova Medicinal has received a maiden order for its Ritual Gold handheld vaporiser products.
The A$12,420 order for 40 cases of one-gram lemon haze vaporisers comes from the Weed Pool Cannabis Cooperative, a group of independent retailers in Saskatchewan.
The Ritual Gold range utilises Mernova’s high-THC cannabis flower and marks the firm’s entry into the rapidly growing cannabis vaporiser market. The new one-gram product uses cannabis trim and other biomass not optimal for retail sale, potentially increasing revenue from unused inventory.
Managing director William Lay said: “Ritual Gold is an important launch for Mernova that provides access to a large and growing market, and reduces the amount of dried flower wastage coming from our facility.”
Greenfern has received an initial two-year binding offtake order for the purchase of its medicinal cannabis. The firm said the product would be for use in “an overseas medicinal market” in a deal which could be worth more than NZ$1.6 million over the contract’s duration.
Last week, Greenfern announced it had attained Good Agriculture and Collection Practice certification for its Taranaki cultivation facility.
As the company prepares to raise capital in H2 2022, its current facility will be utilised until a larger, phase two facility comes online.
Managing director Dan Casey said: “It’s quite a strategy to not get too far ahead of ourselves by over-capitalising on infrastructure before the markets are ready and the regulations are met, but at the same time you don’t want to miss opportunities as they present themselves. It’s a real balancing act.”
Greenfern is currently preparing a consignment for testing to meet New Zealand minimum quality standards. Once this is completed, the first batch will be ready for shipment.