Medical cannabis company Zelira Therapeutics (ASX: ZLD) has committed to a binding five-year agreement with US-based company Cardiovascular Solutions of Central Mississippi (CVSCM) to develop and commercialise products to treat symptoms associated with peripheral arterial disease (PAD) and diabetic neuropathies (DPN).
PAD is a circulatory condition in which narrowed arteries reduce blood flow to the limbs and DPN is a type of nerve damage that can occur in diabetes patients.
Despite acknowledging that it was too soon for the commercial impact of the new contract to be clear, Zelira declared that the deal had the “potential to create a future long-term revenue stream” for the company.
Moreover, Zelira said the deal would help its continued evolution towards becoming a revenue generative commercial company by expanding and complementing its strategic interests in cardiovascular indications while maintaining focus on the global launch of its proprietary Zenivol and HOPE products.
As part of the agreement, Zelira has agreed to grant an exclusive licence to CVSCM to manufacture and sell its proprietary formulations in the US with all future products developed under this agreement to be based on “CBD and other cannabinoids” derived from hemp.
Zelira said it intends to use its existing expertise to develop products providing novel and proprietary therapeutic options with potentially improved efficacy and better tolerability to target a significant an unmet need in addressing PAD and its debilitating complications.
Under the agreement, Zelira will receive a non-refundable upfront licencing fee, with royalties to be received on the commercialised products that follow.
Both companies have confirmed that if they can make developmental progress, they will look to “rapidly commercialise” these products in significant global markets with CVSCM retaining exclusive US marketing rights and Zelira retaining rights for all other markets.
Importantly, Zelira confirmed that all product development and commercialisation costs in the US will be borne by CVSCM.
“There has been significant progress in the understanding of the molecular mechanisms of cannabinoid action that target multiple medical conditions,” CVSCM chief executive officer Dr Foluso Fakorede said.
“A number of these cannabinoid-based medicines are approved by the US Food and Drug Administration’s (FDA) on the basis of scientific evidence. Our mission is to promote the prevention and treatment of cardiovascular disease in all patients and to achieve health equality for marginalised communities through implementation of applications that address unmet needs,” Dr Fakorede added.
Diabetes has become a global public health crisis costing around US$326 billion in healthcare costs every year.
According to the US Center for Disease Control, as many as 30% of people in the US will develop diabetes by 2050 with two debilitating complications of the disease being the development of what’s known as “atherosclerosis” – a build-up of plaque inside arteries – which ultimately leads to greater incidence of PAD and DPN.
Furthermore, PAD is the leading cause of non-traumatic amputations and triggers a series of other conditions that further reduce patient survivability and raising healthcare cost burdens.
Of the 30 million Americans that currently suffer from diabetes, one out of three over the age of 50 are expected to develop PAD.
Globally, it is estimated that the prevalence of peripheral arterial disease is 200 million, according to a Global Burden of Disease survey published in 2016.
“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,” Zelira chief executive officer and managing director Dr Oludare Odumosu said.
“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,” he said.