Australian delivery for use under the Special Access Scheme is expected by Christmas 2019.
This is the third cannabinoid product Medlab has produced and like the previous two, it utilises Medlab’s proprietary delivery system NanoCelle and maintains all the rigours of quality in the manufacturing cycle.
Other countries that allow CBD from hemp instead of marijuana, specifically the US market, are being investigated with potential partners.
“Capabilities of NanoCelle delivery platform”
Medlab chief executive officer Sean Hall said: “NanoCBD is another example of the capabilities of Medlab’s patented NanoCelle delivery platform
“The order is the start of global expansion for the product, with opportunities in the USA to follow.
“Once manufactured, NanoCBD will be available in Australia under SAS.”
Local and global commercial opportunities
NanoCBD is a standardised formulation containing 16.67 milligrams per millilitre cannabidiol from hemo, as an active ingredient, in a sub-micron spray applied to the oro-bucal membrane.
NanoCBD has local and global commercial opportunities, allowing for expanded commercial reach where hemp products have been legalised.
Like Medlab’s other two cannabis products NanaBis and NanaBidial, NanoCBD is made under either an Australian (TGA) or US (FDA) approved drug manufacturer to ensure quality and consistency in the formulation.
Three business divisions
Pharmaceuticals is one of three Medlab divisions, along with the Nutraceuticals business and the Medlab technologies group focused on commercialising NanoCelle.
Medlab’s core objective for the Pharmaceutical division is to achieve a drug registration with approved health claims, for example, NanaBis where it continues to make progress through the phase-two clinical trial at Royal North Shore.
Trial progress and the pursuit of drug registration will underwrite a global opportunity in pain management.
Patient data and revenue
In conjunction with the drug registration process, Medlab continues to exercise numerous other paths of commercialisation including product sales in compassionate access schemes such as the Australian TGA SAS category B scheme and other over-the-counter opportunities globally.
These initiatives provide valuable patient data and revenue.
The Pharmaceutical approach uniquely differentiates Medlab from others in the cannabis sector, which are not exposed to the rigours of clinical trials, manufacturing at licenced drug facilities, or oversight and scrutiny from the TGA, FDA and the EMA.
Medlab’s portfolio of potential clinical claims now include:
NanaBis – cancer pain, but also showing very encouraging data in neuropathic pain;
NanaBidial – seizures and chemotherapy-induced nausea and vomiting; and
NanoCBD – inflammation, anxiety.