Medlab Clinical (ASX: MDC) has collared a heads of agreement with Australia’s largest generic over-the-counter (OTC) supplier Arrotex to fast-track availability of its proprietary cannabinoid formulation NanoCBD throughout Australian pharmacies.
The deal’s intent is to accelerate the clinical package required for final lodgement and securing Therapeutic Goods Administration approval as a Scheduled 3 or pharmacist only medicine.
Medlab noted Arrotex had “extensive experience” in the TGA application process as Australia’s largest generic pharmaceutical and private label OTC medicines company.
Arrotex is also supported by what is described as the nation’s pharmaceutical sector’s largest sales force – supplying medicines for up to 85% of Australian prescriptions. Its products are found in every Australian pharmacy.
According to Medlab, the agreement with Arrotex is the first partnership between a pharma and a biotech investigating medical cannabis in Australia.
“Unlike many CBD producers, Medlab can deliver to the pharmaceutical standards required for TGA approval and this partnership will now enable direct application into clinical practice through Arrotex’s extensive network,” Medlab chief executive officer Dr Sean Hall said.
“There is a clear alignment within both companies to deliver a superior, approved CBD product to Australian patients.”
CBD medicines now available OTC
TGA made the decision in September last year to down-schedule low-dose CBD products of 150mg or less from Schedule 4 to Schedule 3 of the Poisons Standard – enabling companies to register their products to be available through a pharmacy without a prescription.
With the TGA’s new regulations taking effect on 1 February, CBD medicines containing up to 150mg per day are now officially classified as OTC and can be purchased without a doctor’s prescription.
However, this does not yet mean they are readily available, with CBD medicine producers still having to jump through TGA hoops to have their medicine classified as OTC.
Arrotex chairman and chief executive officer Dennis Bastas said the company recognised the “significant opportunity” the TGA reclassification brought for CBD medicines.
“As the largest dispensary and OTC supplier in Australia, we believe Arrotex is best placed to deliver this to community pharmacy.”
“Critically, it will be important that this opportunity is realised via the availability of highly efficacious quality CBD formats so we are excited to be pursuing this opportunity with Medlab – one of the leading innovators in the space,” he added.
Medlab’s Dr Hall pointed out that a key differentiator for the NanoCBD product is its NanoCelle proprietary delivery platform.
He said the platform provides “faster and more effective absorption” of active ingredients into the bloodstream without the need for needles and pills.
“It is a commercially viable platform that offers unique opportunities for partnering with some of the biggest players in the pharma industry.”