‘Monumental’ – Bioxyne subsidiary awarded first Aussie GMP licence to manufacture psilocybin, MDMA

Bioxyne’s Breathe Life Sciences subsidiary has been awarded Australia’s first good manufacturing practice licence to make psilocybin and MDMA.

BLS has been granted Australia's first GMP licence to manufacture psilocybin.

Sponsored content

---

Bioxyne says its Breathe Life Sciences (BLS) subsidiary has been awarded Australia’s first GMP (good manufacturing practice) licence to manufacture psilocybin and MDMA (3,4-methylenedioxy-methamphetamine).

Bioxyne (ASX:BXN) has announced that its wholly-owned subsidiary BLS also had been granted a GMP licence to manufacture medicinal cannabis, which has an Australian market valued at $500 million. .

BXN says its Therapeutic Goods Administration (TGA) GMP licence covers parts 1 and 2, allowing it to manufacture MDMA and psilocybin active pharmaceutical ingredients (APIs) as well as final dose form capsules for supply to authorised prescribers and clinical trials.

BLS has been building its medicinal cannabis brand and distribution in Australia since 2022 to capitalise on the growing sector.

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

First to recognise psychedelics as medicine

Australia become the first country in the world to recognise psychedelics as medicine, after the TGA approved psychedelic substances used in magic mushrooms and MDMA last year.

From July 1, 2023, medicines containing the psychedelic substances psilocybin and MDMA can be prescribed by authorised psychiatrists in Australia for treating certain mental health conditions.

Under the new guidance, the TGA permitted the prescribing of MDMA for the treatment of post-traumatic stress disorder (PTSD), and psilocybin for the treatment-resistant depression.

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

Goal to be leading supplier

BXN CEO Sam Watson says the GMP licence demonstrates BLS commitment to the responsible manufacture of alternative medicines which can provide solutions to mental health disorders resistant to current treatments.

“BXN says it intends to be the leading supplier of psilocybin and MDMA for clinical trials and authorised prescribers by 2025,” Watson says.

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

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.

“This is a monumental achievement for our wholly owned subsidiary, Breath Life Sciences and Bioxyne, something the company has been working towards for the last three years,” head of production Macdarragh O’Neill says.

“Not only will we now be able to significantly scale up our pharmaceutical operations in Australia, but our manufacturing licence will also give us the ability to extend rapidly into international markets in which we are already well established.”

Strong growth across company

BXN recently announced it was experiencing rapid growth in the wholesale distribution of medicinal cannabis starting materials in Australia, along with its trademarked Dr. Watson products and final dose form products from its BLS.

“BXN reported revenue growth in Q2 FY24 of +100 per cent on the previous quarter for its medical cannabis business, and an annualised revenue run rate of +$10 million,” Watson said.

To capitalise on growth, BXN in January launched CanXChange, an AI-powered B2B therapeutic goods platform.

The platform provides a portal to facilitate wholesale trading between licensed buyers, sellers, cultivators, and accredited manufacturers in the country with more than $10 million in sales interest during its first week.

---

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.