Agreement to develop and commercialize products that target symptoms associated with peripheral arterial disease and diabetic neuropathies.
Zelira Therapeutics Ltd (ASX:ZLD), a global leader in the development of clinically validated cannabis medicines, is pleased to announce it has entered into a binding product development agreement with USA based Cardiovascular Solutions of Central Mississippi (CVSM) to target symptoms associated with Peripheral Arterial Disease (PAD), associated ischemic neuropathies including Diabetic Neuropathies (DPN).
Our mission is to promote the prevention and treatment of cardiovascular disease in all patients and to achieve health equality for marginalized communities through the implementation of applications that address unmet needs.Dr Foluso Fakorede, CEO of CVSCM
The products to be developed by Zelira under this agreement will be based on CBD and other cannabinoids derived from hemp. These products 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.
Under the Agreement, Zelira will receive a non-refundable upfront licensing fee, with royalties to be received on the commercialized products that result from the Agreement. If successful, Zelira and CVSCM will look to rapidly commercialise these 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 license 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.
In America, diabetes is a public health crisis, costing $326 billion dollars per year, according to the American Diabetes Association. By the year 2050, it is projected that 1 in 3 Americans will have diabetes according to a recent analysis from the Centers for Disease Control1. Racial and ethnic minorities have the highest prevalence and the greatest burden of complications compared to Caucasian Americans. Two debilitating complications of diabetes are the development of atherosclerosis leading to PAD and DPN.
PAD is the leading cause of non-traumatic amputations. For the 30 million Americans who suffer from diabetes, 1 out of 3 over the age of 50 will develop PAD2. Based on 2016 Global Burden of Disease, it is estimated that the global prevalence of the peripheral arterial disease is 200 million. That represents 25.6% of the global burden of cardiovascular disease. Neuropathic symptoms and impairment increase with disease severity of PAD and diabetes – both areas with documented unmet therapeutic needs.
Associated diabetic neuropathy can also have substantial consequences for patients. Diabetic neuropathy is the most common complication associated with diabetes, which has a lifetime prevalence of 50-70%.
DPN is also a leading cause of disability due to foot ulcerations, gait disturbances; fall risks and can potentially lead to infection and limb amputation. Both amputations and chronic neuropathic pain lead to poor quality of life, loss of productivity to society, high mortality rates comparable to cancer, the significant economic burden to health care systems, and functional limitations caused by symptoms of their underlying diseases. A major complication associated with amputation is that 95% of amputees suffer from chronic pain syndromes.
According to the Centers for Disease Control and Prevention (CDC), type 2 diabetes is responsible for about 90% of diabetes cases due to insulin resistance. High blood sugars damage the vessel walls (capillaries) decreasing the ability to supply nutrients and oxygen to the nerves. When the nerves are damaged, it interferes with the ability to send appropriate signals to the body hence producing wide-ranging symptoms from numbness to constant disabling pain. These patients suffer in isolation, isolated by the physical and financial pain that this silent disease inflicts on them and their families.
Dr Foluso Fakorede, CEO of CVSCM said: "We are delighted to partner with Zelira, one of the world's leading clinical medical cannabis companies, to pursue new and effective treatment options for PAD and Diabetes associated peripheral neuropathies. There has been significant progress in the understanding of the molecular mechanisms of cannabinoid action that target multiple medical conditions. A number of these cannabinoid-based medicines are approved by the U.S 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 marginalized communities through the implementation of applications that address unmet needs."
Dr Oludare Odumosu, CEO & Managing Director USA for Zelira 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. Dr Fakorede and the CVSCM team have led the way in reducing rates of amputations in the Mississippi area through intervention and education on the risks and burden of PAD. Zelira is proud to bring our scientific product development expertise to this unmet need and expands our reach into new indications and markets."
- The Company cannot, at this stage, fully quantify the impact of the contract will have on the price of its securities.
- The Company does not expect, that by itself, the upfront licence fee element of the Agreement will have a material impact on its operations for the financial year ended 30 June 2021, but the Agreement has the potential to create a future long term revenue stream for the Company in addition to its HOPE™ and Zenivol™ products.
- As is usual in agreements, the Agreement is terminable mutually or when one party fails to perform. However, in all instances, the Company continues to own 100% of its intellectual property and the products it develops under this Agreement and keep the non-refundable upfront fees it receives.
- This transaction continues the evolution of the Company from a non-revenue generating company (the Company had no revenue as of 1 January 2020) towards a revenue-generating commercial company.
Disclaimer: Past performance is not an indicator of future performance.
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