How Creso Pharma could benefit from TGA down-scheduling of CBD

Creso Pharma Limited (ASX: CPH; FRA: 1X8) is positioned to significantly benefit from a decision today by the Therapeutic Goods Administration (TGA) to down-schedule low dose cannabidiol (CBD) preparations from Schedule 4 (Prescription Medicine) to Schedule 3 (Pharmacist Only Medicine).

The landmark decision will allow low-dose CBD containing products, up to a maximum of 150 mg/day, up from 6omg a day, for use in adults that have been approved by the TGA, to be supplied over-the-counter by a pharmacist, without a prescription.

The decision also outlines additional limits on dosage form and packaging requirements, including pack size and child-resistant closures.

With regards to the TGA decision, it limits over-the-counter supply to only those products that are approved by the TGA and included on the Australian Register of Therapeutic Goods (ARTG).

The decision has been welcomed by the broader community, with Medical director and addiction specialist at CA Clinics Dr Mark Hardy saying, “This could potentially result in more Australians benefiting from the therapeutic properties of cannabis. However, the effects of low-dose CBD may be negligible for many chronically ill patients.

“Pharmacists would also still need to consult with consumers to ensure they’re aware of potential drug-drug interactions, as CBD can affect the way certain other medications are metabolised. Bottom line, consumers should consult their GP before taking over-the-counter products.”

Applications can now be lodged to the TGA by sponsoring companies for inclusion of Schedule 3 CBD preparations on the ARTG.

For Creso there is only upside.

Creso Pharma has an existing portfolio of CBD products that are currently available in Australia by prescription, including cannaQIX® 50 which is sold under the ‘LozaCan’ brand. Creso will immediately explore the requirements to sell this product, as well as the company’s other GMP-manufactured ranges, more broadly to Australian consumers.

The TGA decision will also allow Creso Pharma to expedite its Heads of Agreement (HOA) with leading natural, sustainable health and lifestyle brand supplier Martin & Pleasance Pty Ltd (M&P) (www.martinandpleasance.com) to bring Creso Pharma’s suite of cannabis-based products to the Australian market, as announced in December.

Martin & Pleasance has established reputation in natural medicines

Martin & Pleasance was established over 150 years ago and provides an extensive range of natural remedies and medicines to consumers.

The group is 100% Australian owned and operated and focuses on pioneering new and emerging products.

M&P’s leading brands include Harmony women’s health range, Ki-Immune range, Vital Nutritional Products, Schuessler Tissue Salts, Zen Joint & Pain relief, He Men’s health, as well as a comprehensive range of brands targeting consumers through various lifestyle stages and health conditions.

M&P has an extensive field force directly servicing over 4,000 pharmacies across Australia and New Zealand in addition to its online channels, grocery and practitioner suppliers.

The company also has direct interests in Canada and the UK, servicing key customers in the natural and mass channels with their brands.

Creso products to be sold under M&P brand in Australia and New Zealand

Under the non-binding agreement, the parties have confirmed their intention to negotiate and enter into a formal binding and exclusive Collaborative Agreement on or before 30 April 2021 under which it is envisaged that Creso Pharma will manufacture a range of cannabidiol products in Switzerland, which would be then sold under new and existing Martin & Pleasance brands in Australia and New Zealand.

Products expected to be sold include the company’s proprietary nutraceutical range in lozenge and tea form, which are all manufactured in a GMP-certified compliant facility.

In commenting on the significance of these regulatory changes and in particular the potential to add value for its shareholders, non-executive chairman, Adam Blumenthal said, “Today’s decision by the TGA is a major step forward for the Australian market, which we expect to grow rapidly in the near term.

"Australia has always been of considerable focus for Creso Pharma, and the company has been actively establishing its footprint through existing relationships in the country that it can leverage immediately.

"An example of this is our agreement with Martin & Pleasance, which we will now progress as quickly as possible to unlock value for our shareholders.

"We look forward to providing ongoing updates on our growth in Australia, as well as other key marketing initiatives, including Europe and North America in the coming weeks.”

After a flow of promising news in recent weeks, Creso Pharma’s share price closed at 30 cents last week, a long-term record and representative of a ten-fold gain in a fortnight.