Medlab, Arrotex to Fast Track S3 CBD
Biotech firm, Medlab, has signed a non-binding Heads of Agreement (HoA) with generic medicines group Arrotex Australia, to develop and distribute a Pharmacist-Only medicinal cannabis product.
With commercial terms set to conclude on or before 01 Jul, the companies are looking to develop a fast track for the clinical package required for final lodgement of an application with the Therapeutic Goods Administration (TGA) for “a near future Schedule 3” approval for Medlab’s NanoCBD.
Medlab CEO, Dr Sean Hall, described the HoA as “a major milestone for both the Australian market and the budding partnership between Medlab and Arrotex”.
"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,” he said.
Arrotex CEO, Dennis Bastas, said the company recognised the “significant opportunity the down schedule of CBD to Pharmacist-Only medicines schedule represents for both patients and pharmacists”.
“As the largest dispensary and over-the-counter supplier in Australia, we believe Arrotex is best placed to deliver this to community pharmacy,” he said.
“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 this space.”
Former Pharmacy Guild of Australia National President, Kos Sclavos, said the protocols being developed through the Medlab, Arrotex collaboration would ensure pharmacists dispense the specific CBD formulation for the approved indications.
“The protocols will also include referral pathways to doctors,” Sclavos said.
Source: Pharmacydaily.com.au, Thursday 17 February 2021
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