SYDNEY: Emerald Clinics Limited, a leader in the collection and clinical translation of Real-World Evidence technologies, has been engaged by Spectrum Biomedical UK (SBUK), the UK subsidiary of the world’s largest cannabis company Canopy Growth, to develop a Real-World Evidence system in the United Kingdom (UK).

Under the agreement Emerald will design and deliver a Real-World Evidence asset focused on the safety and clinical outcomes for cannabis-based medicines produced by SBUK.

Emerald will be responsible for the collection of specific data points including de-identified patient information, use of concomitant medicines, prescribed usage and diagnoses, and a range of patient reported outcome measures. These data will then be provided to SBUK to guide and strengthen their treatment development programs.

“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,” said Emerald CEO Dr Michael Winlo.

“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.”

Emerald will receive a design and development fee upfront of £150,000 (A$270,000), in addition to a £300 (A$542) per patient fee. The total fees as part of this initial contract are capped at £400,000 (A$723,000) and Emerald will have 24 months to deliver on the contract from commencement. As part of the contract with SBUK, Emerald 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.

Spectrum Biomedical UK was established in 2018 and is focused on providing access to cannabis-based medicinal products to UK patients with unmet clinical needs. It is the UK-focused, biopharmaceutical arm of Canopy Growth, a world-leading diversified cannabis, hemp and cannabis device company with operations in more than 12 countries.

“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 PTSD”, said Emerald Clinics Medical Director Dr Alistair Vickery.

Industry analysis from Prohibition Partners has forecast the UK medicinal cannabis market could reach almost £1 billion by 2024 with more than 340,000 patients accessing cannabinoid-based medicines.

The agreement with SBUK builds on the existing relationship Emerald has established with Spectrum Therapeutics, the Australian arm of Canopy growth. In November 2019 the parties announced an agreement under which Emerald collects clinical outcome data for up to 500 patients using Spectrum Therapeutics products in Australia.