The developer of clinically validated cannabinoid-derived medicines has entered into the necessary manufacturing and distribution agreements and has also finalised branding and packaging details.
It has engaged one of Australia’s leading healthcare agencies, which specialises in outsourced sales solutions, to support the company’s Australian launch of all three products.
This phase marks a major milestone for Zelira as it accelerates its transition from a purely research-based organisation to become a revenue-generating company.
Zelira is undertaking product development programs targeting specific conditions and human clinical trial programs focused on insomnia, autism and opioid reduction in patients with chronic non-cancer pain.
This work is carried out in partnership with world-leading researchers and organisations including Curtin University in Perth, Western Australia; the Telethon Kids Institute in Perth; the University of Western Australia, in Perth; St Vincent’s Hospital in Melbourne, Australia; and the Children’s Hospital of Philadelphia in the US.
Zelira’s commercialisation plans are focused on the launch of up to five different products into global markets in the second half of 2020.
These include the Zenivol™ and HOPE™ range of products in Australia, an aged care formulation, which is expected to launch at the end of the year in the US and a new over-the-counter (OTC) product line that will launch in the US in the next quarter.
The company has developed two proprietary formulations (HOPE™), which have already been launched and generating revenues in Pennsylvania.
Zelira continues to progress discussions with third parties aimed at licensing its products, including HOPE™ and Zenivol™, in the US.
Products for vascular diseases
In July 2020, the company entered into a binding product development agreement with US-based Cardiovascular Solutions of Central Mississippi (CVSCM) to target symptoms associated with Peripheral Arterial Disease (PAD) and Diabetic Neuropathies.
Products which will be developed under this agreement will be based on CBD and other cannabinoids derived from hemp.
They will provide novel and proprietary therapeutic options with potentially improved efficacy and better tolerability to target a significant unmet need in addressing the epidemic of PAD and its debilitating complications.
CVSCM will be granted an exclusive licence to manufacture, sell and otherwise commercialise Zelira’s proprietary formulations in the USA.
Zelira's CEO and managing director USA Oludare Odumosu said: “Our partnership with CVSCM is in line with our mission to target indications where cannabinoid-based medicines can be used as safe, effective and accessible options.
“This collaboration represents the first of its kind in this field and allows us to focus on the impact of PAD on quality of life for patients.
“Zelira is proud to bring our scientific product development expertise to this unmet need and expands our reach into new indications and markets."
Under the agreement, Zelira will receive a non-refundable upfront licensing fee, with royalties to be received on the commercialised products that result from the agreement.
If successful, Zelira and CVSCM will look to rapidly commercialise the products in significant global markets with CVSCM retaining exclusive marketing rights to the USA market and Zelira retaining rights for all other markets, ex-USA.
The efficacy of the products will be assessed by CVSCM in relevant patient groups in a real-world setting.
All product development and commercialisation costs in the USA will be borne by CVSCM. Zelira exclusively owns all products developed under this agreement.
The licence granted by Zelira to CVSCM for the USA market, with regards to the commercialisation of products developed under this agreement, is for five years, in the first instance, renewable for additional five-year periods.
Asia-Pacific region sales
In May 2020, entered into an agreement with Tasmanian Alkaloids (TasAlk) - a global leader in the extraction and purification of high-value plant-derived products for the pharmaceutical industry - to supply Zenivol™ and HOPE™ in the Asia Pacific region.
Under the deal, TasAlk will have exclusive rights to manufacture and supply Zelira’s Insomnia and HOPE™ formulations initially in the Asia-Pacific region for three years.
In Australia, all products will be supplied to patients under the Australia Government TGA Special Access Scheme (SAS).
Zenivol for chronic insomnia
In April 2020, Zelira achieved a world first when it reported a successful outcome to its Phase 2A trial, which showed that its proprietary cannabinoid-derived drug Zenivol™ is an effective and safe treatment for people suffering chronic insomnia.
This outcome paves the way to launch Zenivol™ into global markets as the world’s most clinically validated cannabinoid-derived medicine for the treatment of chronic insomnia.
The study met its primary and secondary endpoints for safety and efficacy.
Treatment with Zenivol™ was shown to lead to significantly improve key insomnia symptoms, with treated patients showing 26% improvement in their Insomnia Severity Index (ISI) scores – a current standard for measuring effectiveness of insomnia treatments – while patients on the highest dose achieved a 36% improvement in symptoms.
Analysis of secondary endpoints showed treated patients slept significantly longer, went to sleep faster and went back to sleep sooner after waking.
Patients also reported significant improvement in quality of life measures including feeling rested after sleep, feeling less stressed, less fatigued and improved overall functioning.
Sports-related chronic pain study
In June, Zelira entered into a non-binding Heads of Agreement with Melbourne-based medical cannabis company Levin Growing Pty Ltd, now known as Levin Health Ltd, to develop a novel cannabinoid-based treatment for sports-related chronic pain experienced by retired professional and amateur athletes.
Levin will fund the trial while Zelira will be responsible for designing and co-ordinating the study.
Zelira will hold the marketing rights for North and South America with Levin retaining rights to all other world markets.
Profits will be shared equally between both companies.
The trial is expected to commence in 2021 following negotiation of a definitive agreement and finalisation of clinical trial protocols and necessary ethics approvals.
HOPE™ for autism
The pharmaceutical grade product line HOPE™, which was developed to address patient symptoms associated with Autism Spectrum Disorder, successfully launched in Pennsylvania and Louisiana.
Since entering the market, HOPE has shown strong revenue growth establishing itself as a top-selling cannabinoid-derived formulation product line in Pennsylvania.
It has laboratory capabilities to develop formulations in Pennsylvania and Louisiana with the ability to conduct clinical trials and is establishing a national footprint across the USA for the licensing of its products.
In early August, Zelira raised a total of A$8.75 million through the oversubscribed placement of 175 million shares at A$0.05 per share.
The placement received firm bids exceeding twice the intended amount and improves the company’s cash position to around A$10.35 million, before costs.
Funds raised will be used to accelerate Zelira’s plans to launch multiple products into global markets and to advance its planned clinical programs.