BTC Health Limited (ASX:BTC) has announced that its wholly owned investee company, BTC Pharma Pty Ltd, has signed an exclusive distribution agreement with UK-based CNX Therapeutics Limited for Sativex® (nabiximols) oromucosal spray in Australia and New Zealand, with first-year sales expected at around $250,000.

Key Points

  • BTC Pharma signed an exclusive distribution agreement with CNX Therapeutics for Sativex® in Australia and New Zealand
  • Sativex is one of only two medicinal cannabis products registered on the Australian Register of Therapeutic Goods
  • The agreement has an initial term of five years, with an option to extend for a further two years by agreement
  • No upfront or milestone payment is payable to CNX Therapeutics under the agreement
  • Sativex is not expected to have a material effect on BTC's FY27 results

Sativex Product and Therapeutic Indication

Sativex is a prescription medicine made from standardised extracts of the cannabis plant. Each spray delivers a measured dose of THC and CBD in near-equal amounts, absorbed through the lining of the mouth. The product is indicated for moderate to severe spasticity due to multiple sclerosis in patients who have not responded adequately to other anti-spasticity medications. Treatment is initiated by a neurologist or rehabilitation physician, with a clinical review after four weeks. Only patients who show a clinically significant improvement continue treatment. Sativex has been approved in New Zealand since 2010 and registered in Australia since 2012.

Agreement Terms and Responsibilities

Under the distribution agreement, BTC Pharma will become the marketing authorisation holder in both Australia and New Zealand, taking responsibility for regulatory compliance, pharmacovigilance, medical information, market access and sales. CNX Therapeutics will continue to manufacture and supply Sativex from the United Kingdom. The agreement carries an initial term of five years, with an option to extend by a further two years by agreement, and is on commercial terms described as typical for distribution agreements of this nature. No upfront or milestone payment is payable to CNX under the arrangement.

Commercial Outlook and Transition Plans

Sativex is prescribed privately in both Australia and New Zealand and is not subsidised under the Pharmaceutical Benefits Scheme or by PHARMAC. At current prices, BTC expects Sativex sales of around $250,000 in the first full year of supply by BTC Pharma. The product is not expected to have a material effect on BTC's FY27 results. BTC Pharma will work with CNX to transfer registrations and supply arrangements, with continuity of supply for existing patients stated as the first priority. Once the transition is complete, BTC Pharma intends to build engagement with neurologists, rehabilitation physicians and MS patient organisations.