RNS REACH: Early Economic Analysis of 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.

early economic analysis of canpain feasibility study data

 

ENVIRONMENT

Celadon uses a highly controlled indoor cultivation environment in order to produce plants to the tightest pharmaceutical tolerances and cannabinoid content. Hydroponics is used to grow plants in a soilless substrate, with mineral salts dissolved into high quality filtered water and delivered direct to the roots of the plant. Micro-zoned sensors monitor every aspect of the environment in real time; from the room’s temperature, lighting cycles and humidity, to the plant’s mineral absorption and transpiration rates. This allows Celadon to build a data bank of optimal growing conditions for each strain, as well as adjust the room automatically.

TRACKING

Celadon has a bespoke “track and trace” system throughout the production process, providing complete transparency. Each plant is given a unique QR code, allowing it to be traced from its origins through to the final product. IOT boxes are used to automatically feed data into the system, from environmental data to the product’s weight, at each stage of production. This provides full visibility over the production process, as well as inventory tracking and accurate cost analysis which feeds into our accounting systems.

This will close in 0 seconds

Medical Cannabis Market, Transparency Market Research May 2022

This will close in 0 seconds

Stannard et al, (2016) Traditional opioids for chronic non-cancer pain: untidy, unsatisfactory, and probably unsuitable

This will close in 0 seconds

Stannard et al, (2016) Traditional opioids for chronic non-cancer pain: untidy, unsatisfactory, and probably unsuitable

This will close in 0 seconds

Stannard et al, (2016) Traditional opioids for chronic non-cancer pain: untidy, unsatisfactory, and probably unsuitable

This will close in 0 seconds

 

ENVIRONMENT

Celadon uses a highly controlled indoor cultivation environment in order to produce plants to the tightest pharmaceutical tolerances and cannabinoid content. Hydroponics is used to grow plants in a soilless substrate, with mineral salts dissolved into high quality filtered water and delivered direct to the roots of the plant. Micro-zoned sensors monitor every aspect of the environment in real time; from the room’s temperature, lighting cycles and humidity, to the plant’s mineral absorption and transpiration rates. This allows Celadon to build a data bank of optimal growing conditions for each strain, as well as adjust the room automatically.

TRACKING

Celadon has a bespoke “track and trace” system throughout the production process, providing complete transparency. Each plant is given a unique QR code, allowing it to be traced from its origins through to the final product. IOT boxes are used to automatically feed data into the system, from environmental data to the product’s weight, at each stage of production. This provides full visibility over the production process, as well as inventory tracking and accurate cost analysis which feeds into our accounting systems.

This will close in 0 seconds

Legalised in 2018

This will close in 0 seconds

Legalised in 37 States Limited Federal legalisation

This will close in 0 seconds

Legalised in 2016

This will close in 0 seconds

Legalised in 2016

This will close in 0 seconds

Legalised in 2016 Rapid growth to >200k patients (2019-21)

This will close in 0 seconds

Legalised in 2001

This will close in 0 seconds

BUSINESS DESCRIPTION

 

Celadon Pharmaceuticals Plc is a UK based pharmaceutical company focused on the research, cultivation, manufacturing, 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 operates to an EU-GMP standard and comprises indoor hydroponic cultivation, proprietary GMP extraction and manufacturing and an analytical and R&D laboratory. The Company's subsidiary, LVL, owns a MHRA conditionally-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 licenced cannabinoid medicine to treat children with Autism Spectrum Disorder.

This will close in 0 seconds

COUNTRY OF INCORPORATION/OPERATION

 

Celadon Pharmaceuticals Plc is incorporated in England and Wales and is listed solely on the London Stock
Exchange Alternative Investment Market (AIM), and is subject to the UK City Code on Takeovers and Mergers.

TIDM: CEL.L
ISIN: GB00BDQYGP38

There are no restrictions on the transfer of Celadon Pharmaceutical’s shares.

This will close in 0 seconds

AIM SECURITIES IN ISSUE

 

The following information is correct as at 29th September 2023.

The Company’s issued share capital comprises

61,669,773 ordinary shares

Each with a nominal value of 1 pence

So far as the Company is aware, 44.47% of its issued share capital is not in public hands.

This will close in 0 seconds

Scroll to Top