PERTH: Zelira Therapeutics Ltd, a global leader in the development of clinically validated cannabis medicines, 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), a news release said.
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.
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 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”.