Earlier this morning, our innovative cannabis Investment Bod Australia (ASX:BOD) announced it had entered an exclusive 5-year licensing and supply agreement for a Schedule 3 (pharmacist-only) CBD (cannabidiol) product to treat insomnia, which is currently in development.
The agreement is with Arrotex Pharmaceuticals, Australia’s largest supplier of generic drugs to pharmacists that services over 5,700 pharmacies nationwide.
Under the terms of the agreement, BOD is to receive an upfront $500,000 cash payment for exclusive supply of the final product to Arrotex.
It is only very recently that CBD treatments have been made available for purchase at pharmacists. In February, the Therapeutics Goods Administration (TGA - think of them as the regulators for Australian pharmaceuticals and medical treatments) down-scheduled low dose CBD for over-the-counter purchase (sales without a prescription).
Whilst it is now legal to sell CBD treatments at pharmacies, no CBD drugs have yet been approved for sale in Australia. BOD hopes to be one of the first - if not the first - to offer CBD products nationwide. So the agreement with Arrotex is a major step forward.
How is BOD’s progress with developing the product?
A Phase IIb clinical trial is underway, with first participants already enrolled. Once completed (we expect this sometime in 1H2023), BOD will submit a Schedule 3 dossier to the TGA. If approved, that would pave the for Arrotex to distribute to its extensive network of pharmacies.Experts recruit bad sleepers for cannabis trial
We also note BOD’s positive results from a Phase 1 Clinical Trial of its novel CBD soft-gel delivery format announced last week.
This supported the potential for BOD’s unique ECS BioAbsorb Soft Gel to be the benchmark delivery format for this OTC CBD market, with the trial reporting superior bioavailability (i.e. the extent a drug becomes completely available to its intended biological destination) than alternative formats.
Those results bodes well for this soft-gel tablet to become an OTC purchase option for BOD’s insomnia treatment, provided a successful outcome with the current clinical trials.
With ethics approval already granted for the clinical trial for the CBD-based insomnia treatment, we’re keen to see progress on patient recruitment (which has already begun). A dossier submission to the TGA is expected in 1H23.
Subject to the outcomes of the trial, it’s feasible that BOD could have its CBD treatment for insomnia available in pharmacies by late 2023/ 1H2024, positioning it as one of the first to offer such products in Australia.
We're also keen to see BOD's progress with the acquisition of the Aqua Phase technology, which we recently covered - BOD’s big bet – will it pay off?