South America-based Clever Leaves has been granted Australian GMP certification for its facilities in Colombia, allowing it to manufacture cannabis products for the local market.
Confirmation of its GMP status by the Therapeutic Goods Administration (TGA) was welcomed by the firm which now claims to be the first medicinal cannabis company globally to hold GMP certifications from the European Union, Colombia, Brazil, and Australia.
Clever Leaves chief executive Andres Fajardo described the certification as a “major milestone” for the business.
“[It] further highlights our commitment to producing high-quality and safe cannabis products in one of the fastest growing and largest medicinal cannabis markets globally,” he said. “We will continue distributing through our partners, with whom we are already distributing finished cannabis products to patients in the country.”
The firm said GMP standards safeguard against a range of issues including product contamination, variations in compound concentrations and incorrect labelling.
Since July 1 2023, GMP certification has been a pre-requisite for the manufacturing and commercialisation of cannabis products in the Australian market.
Cronos Group is expanding distribution into Australia with its first shipment of cannabis flower to Vitura Health. The Canadian firm holds around a 10% share in Vitura, which was formerly known as Cronos Australia.
Cronos Group chairman, president and CEO Mike Gorenstein said: “Supplying the Australian market, which has grown significantly in the past three years, is a great milestone for Cronos as we aim to enter and expand within international markets.
“We look forward to working closely with our partners at Vitura to provide patients with high-quality cannabis products and establish our presence in Australia as a trusted cannabis partner.”
Breakthrough cancer pain (BTcP) has been selected as the key area of focus for InhaleRX’s phase 2 clinical trial of its synthetic THC drug, IRX211.
After initially exploring the treatment of complex regional pain syndrome (CRPS), InhaleRX’s medical team have selected BTcP as the primary indication.
A patent application has been filed with the Australian Patent Office.
Chief scientific officer Rob Jenny said targeting BTcP provides the company with a far larger patient population.
“We believe IRX211 will find its way to market more rapidly via a clinical program involving the BTcP population and will underpin further product extensions targeting other similar pain indications, including CRPS,” he said.
A phase 1 clinical trial of IRX211, which is delivered via inhalation in a fixed dose, has already demonstrated “pleasing preliminary results” for pharmacokinetics, safety and tolerability for patients with acute episodic bursts of breakthrough pain, the firm said.
Meanwhile, InhaleRX ended 2023 with cash reserves of A$714k having spent $242k on operating activities during the last quarter.
The company received $546k via a financing facility with Radium Capital which allowed early access to a part of its R&D tax incentive claim for 2023.
Emyria has received a R&D tax incentive refund of A$2.53 million for research activity performed during FY23.
CEO and MD Dr Michael Winlo said the refund “reflects Emyria’s deep investment into mental health research and development over the past financial year and follows our key specialist psychiatrist obtaining Authorised Prescriber status last week.
He added: “The period was marked by significant milestones in our quest to develop and deliver innovative mental health treatments for the large number of patients who are not able to find relief through conventional care.”
CannMart, a subsidiary of Canada-based med-tech firm Lifeist Wellness, will begin supplying cannabis products to Australia under an agreement with Aura Therapeutics.
The deal will see the Australian firm, which rebranded from Endoca Australia last October, import a range of medicinal concentrates and live resin vapes, bulk flower, and other refined concentrates.
It marks the first international expansion for the Canadian firm and its in-house brand, Roilty.
“We are excited to bring a diverse range of CannMart products to the Australian market in 2024,” said Aura Therapeutics CEO Tom Fay.
“We have confidence in the anticipated growth of the Australian medical cannabis sector in the coming year and believe our collaboration with CannMart will enable us to capitalise on this expansion by offering an extended range of high-quality products to Australian patients.”
CannMart CEO Daniel Stern said the agreement will enable it to expand revenue streams, while building an international brand presence for CannMart and its Roilty concentrates.
Cann Group has named Tony Di Pietro as its new chief financial officer following the departure of Deborah Ambrosini before Christmas.
He will also become joint company secretary with head of legal and regulatory affairs Steven Notaro.
Di Pietro joins Cann Group from med-tech firm Genetic Technologies where, as CFO, he managed a US$5 million capital raise from US investors and oversaw due diligence and compliance activities with the ASX and NASDAQ.
Cann Group CEO Peter Koetsier said Di Pietro has a “brilliant track record of helping to oversee the successful evolution of smaller companies into established successful operations that generate outstanding profits”.
Greenfern Industries (GFI) has met the New Zealand regulator’s minimum quality standards to commercialise its first cannabis harvest at its cultivation, drying and packaging facility in Taranaki.
Managing director Dan Casey said the milestone was “testament to all the hard work and research that our team have diligently put together over the last few years”.
“We are looking forward to finalising our first batch in preparation for export and look forward to even more wins in the near future,” he said.
The harvest is being prepared for export to the EU and UK through Greenfern’s partner Ampyl Sciences.
Casey added: “Despite the journey to get here, which has been a slow and complex industry pathway for all domestic players, some of whom have not survived, GFI has achieved something worth celebrating and we feel excited that this is just the start of our cultivation vision.
“We will now look to make sure we continue to bring the best quality medicinal cannabis to the international and, in time, the New Zealand markets.”
LGP/Reset Mind Sciences
Little Green Pharma’s psychedelics-focused subsidiary Reset Mind Sciences has launched its clinical trial into the safety and efficacy of psilocybin-assisted therapy involving family members for 60 patients with treatment-resistant major depressive disorder.
Screening of potential participants has commenced with the trial expected to take 12 months to complete. Academic and consultant psychiatrist Professor Sean Hood from the University of Western Australia will be principal investigator.
Meanwhile, an extraordinary general meeting to consider the demerger of Reset Mind Sciences from LGP is set for January 17.
The move is conditional on the successful completion of a capital raise of up to A$2 million by the issue of up to 10,000,000 ordinary shares in Reset at $0.20c per share.
UPDATE (January 17, 2024): The closing date for the capital raise has been extended to February 20 to “enable international investors to obtain regulatory investment approval and make a final investment decision”.
The EGM will now take place the following day (February 21).