• Bioxyne subsidiary Breathe Life Sciences granted upgraded and amended wholesale licence for MDMA and Psilocybin
  • Licence enables supply to authorised prescribers, pharmacies, and clinical trial sponsors across Australia 
  • Breathe Life Sciences was awarded Australia’s first GMP licence to manufacture psilocybin and MDMA


Special Report: Bioxyne says its wholly owned Breathe Life Sciences subsidiary has been granted an upgraded and amended wholesale licence for MDMA and Psilocybin (schedule 8) finished products by the Therapeutic Goods Administration.

Bioxyne (ASX:BXN) says the licence enables BLS to supply authorised prescribers, pharmacies, and clinical trial sponsors across Australia with MDMA and psilocybin finished products.

BXN CEO Sam Watson says the upgraded licence for BLS is another significant milestone in the company’s mission to develop and promote access to psychedelic medicines in Australia and abroad.

In February BXN announced that BLS had been awarded Australia’s first Good Manufacturing Practice (GMP) licence to manufacture psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) along with one to produce medicinal cannabis.

The GMP licence covers parts 1 and 2, allowing BLS to manufacture MDMA and psilocybin active pharmaceutical ingredients (APIs) as well as final dose form capsules for supply to authorised prescribers and clinical trials.

The TGA has additionally issued BXN a GMP licence for manufacturing medicinal cannabis, where it is targeting an Australian market worth $500 million.

BLS has been establishing its medicinal cannabis brand and distribution channels in Australia since 2022, aiming to capitalise on opportunities in the expanding sector.

Watson says its medical cannabis manufacturing licence is the largest issued to date in Australia in terms of scope covering final product dose forms.

“We have been inundated with client orders and manufacturing orders following the news of our manufacturing license with approximately $8m in new business and sales orders added to the pipeline in just the last 2 months,” Watson said.

“Business is on the up! We are also weeks away from going live with manufacture of THC and CBD pastilles (gummies), which I believe will be another first for the Australian market.

“By comparison, edibles make up 30% of the Canadian cannabis market. It’s a big opportunity for us to make these products locally.”


First country to recognise psychedelics as medicine

Australia became the first country to officially recognise psychedelics as medicinal substances last year, when the TGA rescheduled compounds found in magic mushrooms and MDMA.

Starting from July 1 2023, authorised psychiatrists in Australia could prescribe medicines containing psilocybin and MDMA for specific mental health conditions.

According to the new guidelines, MDMA can be prescribed for the treatment of post-traumatic stress disorder (PTSD), while psilocybin can be used for treatment-resistant depression.

MDMA is showing promising results for dealing with PTSD, while results from early-phase trials of psilocybin suggest that a single or few sessions of psilocybin-assisted therapy can lead to significant and sustained reductions in depressive symptoms.

Watson says the GMP licence along with upgraded and amended wholesale licence for MDMA and Psilocybin (schedule 8) finished products demonstrates BLS’ commitment to the responsible manufacture of break through and investigational medicines.

He says the company intends to be the leading supplier of psilocybin and MDMA for clinical trials and authorised prescribers by 2025.

“The company is focusing on partnerships with veteran groups, universities in Australia and internationally, trial sponsors and authorised prescribers in Australia,” Watson said.

Furthermore, BXN plans to register the psilocybin and MDMA capsules on the Australian Register of Therapeutic Goods for export in 2024 to supply companies, universities, and clinical trials globally.

“There’s a significant opportunity for Australian manufacturers to become global leaders and suppliers of these investigational medicines to international trials and universities. We have been approached by research groups in Europe and the US and are actively pursuing these opportunities.”


Robust growth across organisation 

Watson says the company is experiencing strong growth across wholesale distribution of medicinal cannabis starting materials in Australia, in addition to its trademarked Dr. Watson products and final dose form products.

BXN’s revenue increased more than 100% in Q2 FY24 compared to the previous quarter for its medical cannabis business, achieving an annualised revenue run rate exceeding $10 million.

To leverage the growth, BXN introduced CanXChange in January, an AI-powered B2B platform for therapeutic goods.

Serving as a gateway to facilitate licensed Australian buyers with accredited cultivators and manufacturers overseas and in Australia, CanXChange generated more than $10 million in product listings during its inaugural week.

“We are working exclusively with some of the best cultivators and manufacturers around the world to procure a wide range of GACP and GMP starting materials, APIs and finished products at very competitive prices,” Watson said.

“The import market is thriving as local cultivators cannot keep up with patient demand. We want to ensure consistent supply and affordability for our Australian patients and local businesses.”



This article was developed in collaboration with Bioxyne, a Stockhead advertiser at the time of publishing.  

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.