Vancouver-based biotechnology firm PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTC:PMBHF) has confirmed its first purchase order for GMP LaNeo MDMA from Cortexa, its joint venture with Australian company Vitura Health (ASX:VIT). The order includes both finished capsule and raw API forms of the compound.
The company announced the USD$300,000 order purchase this week and includes an amount of GMP Psilocybin API, indicating a broadening of the product range within the venture.
“The long-term view on Cortexa is that it must – and will – stand on its own two feet in the Australian market, which we believe is more than capable of supporting manufacturing operations domestically,” said Nick Kadysh, Chief Executive Officer of PharmAla.
Kadysh added that the company transferred all of our manufacturing know-how to Cortexa as part of our Joint Venture agreement with Vitura
“However, with the launch of the TGA’s regulatory changes allowing for the use of MDMA and psilocybin by authorized prescribers as of July 1 – and demand ramping – we believe it makes sense to fulfill that demand immediately with previously-made materials in PharmAla’s Canadian inventory.”
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Australia, the first country to legalize medical MDMA and psilocybin
Australia became the first country in the world to legalize the clinical prescribing of MDMA and psilocybin, a move that has been described as “one of the biggest evolutions in psychiatry in the last 70 years”. The Therapeutic Goods Administration (TGA), Australia’s medicines regulator, announced the change in February, and it came into effect last Saturday.
MDMA and psilocybin were down-scheduled from the strictest controlled category, schedule 9 (prohibited substances), to schedule 8 (controlled drugs), but only for medical use in psychedelic-assisted psychotherapy. MDMA is used for the treatment of post-traumatic stress disorder (PTSD), while psilocybin is prescribed for treatment-resistant depression.
The drugs can only be prescribed by psychiatrists with pre-approval via the TGA’s authorised prescriber scheme, for the treatment of PTSD or treatment-resistant depression. The treatment will likely be expensive, with estimates suggesting that a round of psychedelic-assisted sessions may cost between $15,000 and $25,000.
The drugs are administered in a controlled clinical setting, with a small number of full-day, high-dose sessions accompanied by pre- and post-psychotherapeutic support.
PharmAla announced last April that Incannex Healthcare Ltd (ASX: IHL) (NASDAQ: IXHL) will be using its MDMA at Incannex psychedelics clinics in Australia. In February, PharmAla signed an agreement with Emyria Limited (ASX: EMD) (ASX: EMD) to supply its LaNeo MDMA product.
Last May, PharmAla received approval to provide MDMA to a physician that will be administering the drug through Health Canada’s Special Access Program (SAP).
Besides PharmAla, other Canadian companies manufacturing psychedelics with ties to Australia include Optimi Health Corp. (CSE: OPTI)(OTCQX: OPTHF)(FRA: 8BN) which entered into a long-term distribution agreement with Mind Medicine Australia (MMA), a leading charitable organization and patient advocacy group in Australia.