Breathe Life Sciences, a subsidiary of ASX-listed Bioxyne, has received a Good Manufacturing Practice licence from the Therapeutic Goods Administration (TGA) to manufacture medicinal cannabis, MDMA and psilocybin.
Head of GMP production Macdarragh O’Neill described it as a “monumental achievement” that has been three years in the making.
“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 enable the company to bulk manufacture its trademarked Dr Watson medicines, as well as increase supply for third parties.
Meanwhile, MDMA and psilocybin will be supplied to Authorised Prescribers and for clinical trials, with Bioxyne planning 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 will distribute its medicinal cannabis products under the Wellness Life brand through New Zealand clinic CannaPlus from the third quarter of 2024.
It follows a deal struck with CannaPlus parent Elysian Pharmaceuticals.
Elysian will handle all marketing and distribution, subject to regulatory approval, which is expected to take four to 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.”
Hemp extract manufactured by Elixinol is safe to use and has no adverse side effects, a study conducted on rats has found.
A paper published in the Journal of Toxicology also concluded that it may have some benefits for human health, although further studies are needed.
The product tested contained 62% hemp extract, 8% CBD isolate and 30% copaiba, a resin that comes from a tropical tree and has anti-inflammatory properties.
Two studies were carried out; the first over 15 days and the second spanning 90 days.
Both found the extract did not cause any harmful effects although some changes in the rats’ liver cells were reported, along with changes in liver weight. However, they were not serious and did not affect the liver function, the paper found.
“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’s Canadian adult-use business Peak Processing has signed a three-year contract to manufacture six product lines for cannabis-infused drinks firm Collective Project.
The company’s existing range of drinks generate revenue of CAD$6.5 million from 700,000 sales.
Peak claimed it will manufacture 40% of the Canadian cannabis-infused drinks market by the end of March.
The category accounts for 2.1% of the adult-use cannabis market in Canada, with Collective Project capturing 9.6% of cannabis beverage sales.
Health House International
Melodiol Global Health’s Australian distribution division Health House International (HHI) generated A$1 million in unaudited revenue during January.
Melodiol told the ASX the result, together with Canadian operation Mernova’s $1m contribution, takes unaudited revenue for Q1 FY24 to more than A$2m to date, “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.
Meldiol said HHI’s January revenue was generated from its established Australian business, as well as the division’s operations in the UK, with personnel “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.”
New Zealand company Rua Bioscience has entered into an agreement with Apollo Green to introduce its East Coast Tairawhiti cannabis strains into the Canadian firm’s genetics library which includes more than 1,000 unique cultivars.
A wholly owned subsidiary of Biortica Agrimed, Apollo Green has existing sales channels in Europe, North America, Australia and New Zealand.
Rua said Apollo Green provides access to breeder’s rights protection through DNA fingerprinting of all genetics, cultivation capabilities worldwide, as well as licensing and increased 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.”