Under the agreement, TasAlk will have exclusive rights to manufacture Zelira’s Insomnia and HOPE™ medicinal cannabis formulations initially in the Asia Pacific region for the first year and then on a semi-exclusive basis for the subsequent three years.
In Australia, all products will be supplied to patients under the Australian Government TGA Special Access Scheme (SAS).
Shares have been as much as 14% higher to A5.1 cents intra-day and have risen from A2.2 cents at close on March 23.
On-track for launch
The agreement with TasAlk ensures that Zelira remains on-track to launch both the Insomnia and HOPE™ formulations in Australia in the September quarter of 2020.
Once launched, these efforts are expected to transform Zelira into a fully commercial, revenue-generating company in the US and Australia.
Partnering with world-leading manufacturer
Managing director Dr Richard Hopkins said: “We’re delighted to be partnering with TasAlk, one of the world’s leading manufacturers of pharmaceutical-grade plant-derived medicines.
“The agreement reaffirms our commitment to bring our clinically validated products to market in 2020.”
TasAlk chief executive officer Ross Murdoch said: “This agreement aligns with our business model and expertise in providing clinical trial materials.
“It provides the foundation for a long-term partnership that has potential to open up supply opportunities in major world markets for Zelira’s products.”
The manufacture and analytical method for the Insomnia product is under technical transfer to TasAlk from a European GMP manufacturer that supplied material for the recent insomnia clinical trial.
This will ensure TasAlk can achieve rapid commercial-scale production while guaranteeing consistent high-quality products.
Zelira’s experience with the launched HOPE™ product line in the US market is expected to accelerate the manufacture of the HOPE product by TasAlk and represents a major stepping-stone to commercialising the HOPE™ formulations in ex-US markets.
The company recently announced that its proprietary Insomnia formulation, ZTL-101, had successfully met primary and secondary clinical endpoints for safety and efficacy in a Phase 1a/2b clinical trial targeting patients with chronic insomnia.
Its HOPE™ franchise was developed to address patient symptoms associated with Autism Spectrum Disorder. In the US, the franchise was launched in Pennsylvania in May 2019 under Ilera Healthcare, which holds the licence for the state.