Real-world evidence company Emerald Clinics (ASX: EMD) has hauled in a significant new client in the form of Spectrum Biomedical UK (SBUK), the UK-based subsidiary of the world’s largest cannabis company Canopy Growth, to develop a real-world evidence (RWE) system in the UK.
The agreement supplements an existing relationship Emerald has established with Spectrum Therapeutics, Canopy Growth’s Australian subsidiary. In November 2019, the parties announced an agreement under which Emerald would collect clinical outcome data for up to 500 patients using Spectrum Therapeutics products in Australia.
The SBUK relationship also leverages the data platform and remote patient monitoring capabilities being deployed by Emerald in Australia and the US, both in clinical monitoring applications and for population health monitoring with its recently announced Openly initiatives.
Openly is a digital tool designed for organisations to quickly roll out a simple, easy-to-use self-monitoring tool to its team of patrons – whether it be travellers, company employees or returning students – via their mobile device.
Openly captures key vital signs, symptoms and other risk information to identify infection at its earliest stage. The tool attempts to capture and store RWE and real-world data (RWD) to improve clinical analysis of various drugs.
Real-world evidence of increasing relevance in healthcare decisions
Developed as a result of US healthcare reforms in 2016 as part of the 21st Century Cures Act, RWD and RWE are playing an increasing role in healthcare decisions.
For starters, the US Food and Drug Administration (FDA) uses RWD and RWE to monitor post-market safety and adverse events and to make regulatory decisions.
Also, the entire healthcare community is using various data sources to support coverage decisions, develop guidelines and decision support tools for use in clinical practice.
Furthermore, medical product developers are using RWD and RWE to support clinical trial designs including large simple trials, pragmatic clinical trials and observational studies to generate innovative, new treatment approaches.
According to medical professionals, the use of computers, mobile devices, wearables and other biosensors to gather health data has been rapidly accelerating and opens the door to better clinical trial design and more advanced studies that leverage the larger volume of data.
Improving clinical trials
Spectrum Biomedical UK was established in 2018 and provides access to cannabis-based medicinal products to UK patients with unmet clinical needs. It is the UK-focused, biopharmaceutical arm of Canopy Growth, a diversified cannabis, hemp and cannabis device company with operations in more than 12 countries.
Under the terms of the deal, Emerald will deliver an “RWE asset” focused on the safety and clinical outcomes for cannabis-based medicines produced by SBUK.
Emerald will be responsible for collecting specific data points including de-identified patient information, use of concomitant medicines, prescribed usage and diagnoses, and a range of patient-reported outcome measures.
Collated data will then be provided to SBUK to guide and strengthen its treatment development programs, Emerald said.
“We are honoured to embrace this opportunity to work with Spectrum Biomedical UK and the Canopy growth team to realise the potential for a real-world evidence asset, which will help to progress the commercialisation and regulatory acceptance of its medicinal cannabis products,” Emerald chief executive officer Dr Michael Winlo said.
“The evidence and data gathered by Emerald is of exceptional quality and depth, and therefore relevant to licensed producers, regulators, prescribers and importantly, the end patient.”
“We expect to generate more deals with corporate partners to deliver on our IPO goals and to expand our unique RWE model globally,” he added.
In commercial terms, Emerald stands to receive an upfront design and development fee of £150,000 (A$270,000), in addition to a £300 (A$542) per patient fee.
Both parties have agreed to cap fees as part of their initial contract at £400,000 (A$723,000) with Emerald given two years to deliver on the contract.
As part of the contract with SBUK, Emerald said it will maintain independence in how it delivers the clinical care to patients, allowing the ability to establish a UK-based clinic or partner with existing services.
According to industry analysis published by Prohibition Partners, the UK medicinal cannabis market is on course to reach £1 billion (A$1.8 billion) by 2024 with more than 340,000 patients accessing cannabinoid-based medicines.
“Cannabinoid-based medicines continue to be an important alternative for patients who have exhausted conventional therapies and through careful monitoring, remain a significant source of real-world data for exploration of novel interventions for a range of clinical indications including pain, insomnia and post-traumatic stress disorder,” Emerald medical director Dr Alistair Vickery said.