Zelira Therapeutics well-placed to capitalise on expanding global medicinal cannabis sector
Zelira Therapeutics Ltd (ASX:ZLD) (OTCQB:ZLDAF) (FRA:G1G) has strategically consolidated its operations to transfer the leadership of the company to its US-based team, with Dr Oludare Odumosu to assume the role of global managing director. With the successful launch of multiple proprietary products in Australia and the US, Zelira will focus on two key priorities for 2021. They are: Leveraging the competitive advantages of its products to generate revenues in global markets; and Continuing to progress clinical development of selected programs to unlock further value and better inform its marketing strategies. Zelira’s international footprint and exposure to international markets mean it is well-positioned to benefit from the rapidly expanding global medicinal cannabis sector. HOPE™ products In late October 2020, Zelira announced that its proprietary cannabinoid medicines, HOPE 1™ and HOPE 2™, were available for prescription to patients in Australia through the Therapeutic Goods Administration’s (TGA) Special Access Scheme and via Authorized Prescribers. HOPE™ is part of Zelira’s family of revenue-generating medicinal cannabis formulations. The products consist of two pharmaceutical-grade proprietary formulations developed as pharmaceutical-grade products targeting Autism Spectrum Disorder (ASD) as a disease indication. The products are now working their way through the TGA Special Access Scheme, via Authorized Prescribers into the market and patients. US distribution In December 2020, Zelira announced it has entered into a binding licensing agreement with Alternative Solutions LLC, a licensed grower, manufacturer and distributor of medical cannabis products in the District of Columbia (Washington DC) to manufacture and distribute Zelira’s HOPE™ products. Under the terms of the licensing agreement, Zelira will receive licensing fees and ongoing royalties from HOPE™ product sales in Washington DC. Washington DC has reciprocity with 32 other states in the US with approved medical cannabis programs – which expands access to patients registered in all the 32 states as they can legally purchase medical cannabis products at an approved dispensary in Washington DC. Autism observational trial Last year, the company launched an Observational Trial for HOPE targeting patients diagnosed with autism, which will be one of the largest of its kind ever undertaken. In November 2020, Zelira partnered with Emyria to undertake an observational trial in patients diagnosed with Autism Spectrum Disorder (ASD) treated with the HOPE range of products. The 150-patient observational trial will be one of the largest medicinal cannabis studies ever undertaken involving a specific range of products in patients diagnosed with ASD. The study design will facilitate strategic engagement with key stakeholders in the autism community and streamline patient access via Emyria’s national network of specialist medical clinics – Emerald Clinics. Under the terms of the agreement, Emyria will provide Zelira with real-world longitudinal data collected from ASD patients prescribed a HOPE™ product. Data will include patient’s efficacy and safety relating to co-morbidities, concomitant medications, dosing information and patient responses to HOPE™ treatment as measured using standard ASD clinical and behavioural endpoints. Subsequent to the announcement, ethics approval was obtained, which has cleared the path for recruitment to commence from January 2021. The company was encouraged by the significant number of expressions of interest that have already been lodged, suggestive that recruitment will progress rapidly. Future-focused In February, Zelira was appointed to the board of directors of the National Cannabis Roundtable (NCR) in Washington DC, US, and will be represented by Dr Odumosu. NCR is a non-partisan advocacy group focusing on federal cannabis reform in the US and as part of its reform agenda, it is seeking to remove federal restrictions that prohibit medical research involving cannabis and to allow companies to operate legally in the US-based cannabis industry. Zelira is committed to bringing breakthrough therapeutics to market and supports the need for a regulatory framework that will allow the research to expand and grow on a Federal/National level. Going forward the company‘s commercialisation plans are focused on generating revenues from the multiple products it has launched into the Australian and US market and continuing to launch new product lines. The company will also progress additional licensing discussions for HOPE™ and Zenivol™ in the US and look to conclude ongoing negotiations to expand the distribution of these products into other global markets, including Germany and the UK.