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Vitura’s Cortexa becomes first Aus company to supply ecstasy and magic mushrooms under TGA’s prescriber scheme

In July last year, Australia became the first country to legalise ecstasy (MDMA) and magic mushrooms (psilocybin) for mental health disorders, including PTSD and depression. A bold move, it spurred medical businesses into action, seeking the proper approvals and getting the early advantage. At the same time, not all medical professionals were so thrilled, citing the lack of enough studies into the drugs’ effectiveness. 

Nonetheless, the diversified health business Vitura Health (ASX: VIT) has revealed that its joint venture, Cortexa Pty. Ltd., has provided GMP Psilocybin—or magic mushrooms—for therapeutic use by a patient outside of a clinical trial under Australia’s authorised prescriber scheme. Australia currently allows GMP Psilocybin for therapeutic use, making it the only market in the world to do so outside of clinical trials. 

Cortexa is now the first Australian company capable of manufacturing, supplying, and delivering both GMP MDMA and Psilocybin for clinical trials and prescriptions through the TGA’s Authorised Prescriber Scheme.

In May 2023, Vitura announced the formation of a 50:50 joint venture called Cortexa with Canadian-based PharmAla Biotech Holdings Inc. PharmAla specialises in researching, developing, and manufacturing MDXX class molecules, including MDMA. The purpose of this joint venture is to supply both MDMA and Psilocybin that meet the required standards of good manufacturing practice for prescription use in Australia as of July 1, 2023.

On this date, the Therapeutic Goods Administration (TGA) rescheduled these medicines from Schedule 9 to Schedule 8, allowing authorised Psychiatrists to prescribe them under the Authorised Prescriber Scheme. MDMA is prescribed for post-traumatic stress disorder treatment, while Psilocybin is used for treatment-resistant depression.

After rescheduling, Cortexa began establishing its presence in the Australian psychedelic market. The Company has built a national network of relationships with research institutions, key opinion leaders, and emerging clinicians and supported psychiatrists in obtaining their authorised prescriber status. Supply arrangements have been finalised for clinical trials and authorised prescriber usage extending into 2024 and beyond.

Besides its magic mushrooms venture, in H1 FY24, Vitura continued to progress on the medical cannabis front, too. It has been developing and improving the efficiency and functionality of its market-leading platform, CanView. The multisided platform operated by the Company facilitates interactions and the exchange of products and services between four key user groups: suppliers, prescribers, pharmacies, and patients. 

Its revenue remained largely flat at $59.9 million compared to H1 FY23. On the other hand, its profit declined by 57.4% to $3.2 million, citing margin pressures, reduced average selling price, and costs associated with its Doctors on Demand acquisition. This year, in Q3 FY24, the Company also had to address the vape import ban, thus introducing nicotine vaping products to capture a new audience. 

 

Alinda Gupta

Alinda is a Business Reporter for The Sentiment

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