Breathe Life Sciences, a subsidiary of ASX-listed Bioxyne, has been granted a Good Manufacturing Practice licence by the Therapeutic Goods Administration (TGA) to produce medicinal cannabis, MDMA and psilocybin.
Head of GMP production Macdarragh O'Neill called it a "monumental achievement" that took three years to secure.
"Not only will we now be able to significantly scale up our pharmaceutical operations in Australia, our manufacturing licence will give us the ability to extend rapidly into international markets in which we are already well established," he said.
Bioxyne chief executive Sam Watson, who flagged the imminent TGA approval last week, said GMP certification will allow the company to bulk manufacture its trademarked Dr Watson medicines and boost supply to third parties.
MDMA and psilocybin will be directed to Authorised Prescribers and clinical trials, with Bioxyne aiming to be the "leading supplier… by 2025".
"There is a significant market for these products worldwide which have the potential to plug the gap in existing treatment options," Watson said.
Wellnex Life
Wellnex Life has agreed to supply its medicinal cannabis products under the Wellness Life brand through New Zealand-based clinic CannaPlus, with distribution expected to begin in the third quarter of 2024.
The arrangement follows a deal with CannaPlus parent company Elysian Pharmaceuticals.
Elysian will take responsibility for all marketing and distribution, pending regulatory approval, a process anticipated to take between four and six months.
Wellnex Life managing director Zack Bozinovski said: "This partnership not only provides Wellnex with a dependable and defensive revenue, it also provides momentum for the Wellness Life brand which is extremely important as we prepare for the imminent launch of the brand in the lucrative SAS-B market in Australia."
Elixinol Wellness
A rat-based study has determined that hemp extract produced by Elixinol is safe and does not produce adverse side effects.
Published in the Journal of Toxicology, the paper also noted potential benefits for human health, while calling for additional research.
The tested product contained 62% hemp extract, 8% CBD isolate and 30% copaiba, a resin sourced from a tropical tree that carries anti-inflammatory properties.
Researchers conducted two separate studies — one lasting 15 days and a second running for 90 days.
Neither study identified harmful effects, though some changes in liver cell composition and liver weight were observed in the rats. The paper determined these changes were not serious and did not impair liver function.
"The results from the present studies indicate that Elixinol Hemp Extract is well tolerated in male and female Sprague–Dawley rats and this information contributes to the growing amount of safety information available for hemp extracts and specifically highlights the safety profile of Elixinol Hemp Extract," the paper concluded.
Elixinol Group chief executive and managing director Ron Dufficy said: "The positive safety results, now published in a well-respected scientific journal, stand Elixinol Hemp Extract and Elixinol more broadly in good stead for the future of our hemp products and offerings."
Althea
Althea's Canadian adult-use arm Peak Processing has agreed to a three-year manufacturing contract covering six product lines for cannabis-infused drinks company Collective Project.
Collective Project's current drinks range generates CAD$6.5 million in revenue from 700,000 units sold.
Peak said it expects to account for 40% of Canadian cannabis-infused drink production by the end of March.
The drinks category makes up 2.1% of Canada's adult-use cannabis market, with Collective Project holding a 9.6% share of cannabis beverage sales.
Health House International
Health House International (HHI), the Australian distribution arm of Melodiol Global Health, recorded A$1 million in unaudited revenue during January.
Melodiol reported to the ASX that this result, combined with a $1 million contribution from its Canadian business Mernova, brings unaudited Q1 FY24 revenue to more than A$2 million — "a run rate which exceeds record FY23 group revenue of $21.5m".
"This provides the company with a strong foundation for growth, which it intends to capitalise on in the coming months," it added.
Melodiol said HHI's January revenue came from its established Australian business and its UK operations, with staff "advancing multiple sales initiatives to drive sales growth across key markets, while continuing to manage operating expenditure".
CEO and managing director William Lay added: "We expect that both HHI and Mernova will continue to deliver sales in their key territories, where each division has long-standing relationships with customers."
Rua Bioscience
New Zealand-based Rua Bioscience has struck an agreement with Apollo Green to bring its East Coast Tairawhiti cannabis strains into the Canadian company's genetics library, which holds more than 1,000 distinct cultivars.
Apollo Green is a wholly owned subsidiary of Biortica Agrimed and already has sales channels operating across Europe, North America, Australia and New Zealand.
Rua said the agreement with Apollo Green opens up breeder's rights protection through DNA fingerprinting of all genetics, global cultivation capabilities, and licensing and revenue opportunities for Rua.
CEO Paul Naske added: "We are excited about this partnership with Apollo Green and Biortica Agrimed, as it aligns perfectly with our vision to take our unique strains to the world.
"This is more than just an agreement; it's a bridge connecting New Zealand's exceptional cannabis genetics to the world."
