Celadon Pharmaceuticals Regulatory News (CEL)

Celadon Pharmaceuticals Plc

("Celadon", the "Group" or the "Company")

Early Economic Analysis of CANPAIN Feasibility Study Data

London, 7 March 2024 - Celadon Pharmaceuticals Plc (AIM: CEL), a UK-based pharmaceutical company focused on the development, production and sale of breakthrough cannabis-based medicines, is pleased to announce the results of an early economic analysis of the data collected as part of the feasibility study for its fully approved chronic pain clinical trial ("CANPAIN").

The analysis was undertaken by York Health Economic Consulting ("YHEC"), which provides consultancy and research services in health economics. The findings of YHEC's analysis are as follows:

- Patients on the feasibility study recorded an almost 50% (49.6%) reduction in pain scores in the first month of using cannabis-based medicines, with this reduction in pain being sustained throughout the three-month study.

- Patients saw a significant improvement in their mean quality of sleep scores of 1.6 points (p=0.01) and a reduction in the use of opioids and associated medicines.

- When assessed using the economic framework recommended by NICE, adding cannabis-based medicines to the Standard of Care was found to deliver a cost-effective solution and, depending on the price point, a cost saving to the National Health Service ("NHS")

- Patients' quality-adjusted life years also increased.

Background

In October 2018, the UK's National Institute for Health and Care Excellence ("NICE") issued a call for evidence to evaluate the safety and clinical efficacy of cannabis-based medicines for use in humans. In response, Celadon drew up plans for its own clinical trial, which it called CANPAIN. In August 2023, following a three-month feasibility study, the NHS Research Ethics Committee approved the CANPAIN trial for up to 5,000 patients.

After completing the feasibility study, Celadon commissioned YHEC to carry out a comprehensive and independent review of the data generated, and to construct an early economic model. YHEC's findings underscore the safety, tolerability and effectiveness of Celadon's cannabis-based medicines when delivered via an inhalation device for individuals suffering from non-cancer chronic pain.

These findings, which will be built on by the additional data generated by the forthcoming CANPAIN trial, offer a solid foundation for Celadon's engagement with NICE, the NHS and private health insurers in relation to the reimbursement of the cost of cannabis-based medicine treatment. The data represents a significant step towards fulfilling the unmet needs of the millions of patients living with chronic pain in the UK, providing a potential alternative to current treatments (including opioids).

Celadon remains committed to advancing healthcare solutions that improve quality of life and reduce healthcare costs, and looks forward to the commencement of its CANPAIN trial, which will provide the opportunity to further demonstrate the value of its cannabis-based medicines in chronic pain management.

James Short, CEO of Celadon Pharmaceuticals Plc, commented:

"We are incredibly proud to announce these highly encouraging results, which show just how beneficial cannabis-based medicines could be to millions of patients across the UK, whose needs are currently going unmet. This positive data gives us even greater confidence in our forthcoming clinical trial, which will involve up to 5,000 patients and see General Practitioners permitted to prescribe cannabis-based medicines. Once completed, the NHS will have a proven and cost-effective alternative for managing chronic pain, which we are confident will break down the barriers to prescriptions in the UK.

"Our research has also identified additional conditions that could benefit from cannabis-based medicines, significantly expanding the potential patient pool well beyond our initial estimates of 8 million people in the UK alone. This broader scope underscores the transformative potential of our work, and is a momentous opportunity for Celadon, the NHS, and most importantly, for patients. As far as we are aware, this is the only known trial responding directly to the government's call for more comprehensive data on cannabis-based medicines. I would encourage my colleagues across the industry to follow our lead and gather the clinical data required to support NHS prescriptions of cannabis-based medicines."

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About Celadon Pharmaceuticals Plc

Celadon Pharmaceuticals Plc is a UK-based pharmaceutical company focused on the development, production and sale of breakthrough cannabis-based medicines. Its primary focus is on improving quality of life for chronic pain sufferers, as well as exploring the potential of cannabis-based medicines for other conditions such as autism. Its 100,000 sq. ft UK facility is EU-GMP approved and comprises indoor hydroponic cultivation, proprietary GMP extraction and an analytical and R&D laboratory. Celadon's Home Office licence allows for the commercial supply of its pharmaceutical-grade cannabis product. The Group owns an approved clinical trial using cannabis-based medicinal products to treat chronic pain in the UK. Celadon also has a minority interest in early-stage biopharma Kingdom Therapeutics, which is developing a licensed cannabinoid medicine to treat children with Autism Spectrum Disorder.

For further information please visit our website www.celadonpharma.com