In May 2023, diversified digital health company Vitura Health (ASX: VIT) announced a joint venture with Canadian psychedelic company PharmAla Biotech, giving birth to its Melbourne-based psychedelics arm, Cortexa.

Providing an update on the 50-50 venture, the Company has noted an “Australian first” win. Its MDMA bulk GMP (good manufacturing practice) Active Pharmaceutical Ingredient (API) has landed in Australia and is being prepared to be batch-manufactured into finished dosage forms to GMP standards. Cortexa will ensure reliable local supply to meet growing clinical and research demands. 

At the same time, the first GMP MDMA capsules have been imported from Cortexa’s joint venture partner, PharmAla Biotech, and are ready for patient prescriptions and clinical trials.

Vitura’s CEO and Executive Director, Rodney Cocks, said, “In another milestone for both Vitura and Cortexa, we are extremely proud to have landed MDMA product in bulk and patient-ready capsule form into Australia – for clinical and research prescription. By the end of November 2023, we also expect to have landed bulk psilocybin GMP product also for clinical and research prescription. This paves the way for the first expected clinical patients via the TGA’s Authorised Prescriber Scheme access pathway in December 2023.”

On 3 February 2023, the Therapeutic Goods Administration (TGA) announced that starting July 1, 2023, it will permit MDMA prescriptions for post-traumatic stress disorder and Psilocybin for treatment-resistant depression under the Authorised Prescriber scheme. Cortexa has set out to capitalise on this.

Psilocybin bulk GMP API is also in the process of being transported to Australia. Cortexa Psilocybin is of GMP standard and synthetic in origin. Like MDMA, there has been significant interest in the clinical and research prescription of psilocybin. 

The majority of the MDMA shipment is to satisfy demand under existing supply agreements, including leading University clinical trials.

The TGA’s Authorised Prescriber program will treat patients through approved psychiatrists starting in December 2023, outside clinical trials. This follows TGA safeguards for prescribers’ expertise and patient safety.

As the demand for GMP MDMA and psilocybin rises, Cortexa can utilise PharmAla Biotech’s intellectual property to produce bulk API for both substances within Australia through GMP contract manufacturers. This strategic choice helps Cortexa bypass expensive and time-consuming imports and ensures a stable domestic supply for patients and clinical trial participants.

In October 2023, Vitura acquired Doctors-on-Demand, the telehealth service, for $25 million to establish a broader digital health portfolio. In FY23, its revenue was $117.3 million, up significantly from FY22’s $66.9 million. It recorded a profit of $13.7 million. It ended the year with $18.8 million in cash.

With these new partnerships and acquisitions in place, Vitura has a positive outlook for FY24, focusing on Cortexa becoming the mental health prescription of choice by 2024.