The UK-company is based on the development, production and sale of the medicines and agreed two commercial contracts on May 24 and September 5.
The supply of product follows the successful completion of the company’s latest harvest from its UK-based facility, which is being used to fulfil its commercial contracts.
Periodic invoicing has now commenced for both contracts, the first of which is worth a minimum of £3 million of revenue, with up to £1.2 million of revenue anticipated for the second contract.
Celadon signed another commercial contract on November 16 with a leading European medicinal cannabis company. This latest contract has the potential to generate revenue to Celadon of up to £26 million over three years, with the first deliver anticipated in the second half of next year (2024).
James Short, chief executive officer of Celadon said: “The first supply of our pharmaceutical-grade product is a very significant milestone for both Celadon and the wider industry. It has taken four years of hard work from our incredible team to get here.
“Having achieved our licenses and secured our initial commercial contracts, today demonstrates that we are successfully supplying product and realizing revenue.”
Under current laws, safeguards for patients are maintained by specifying that cannabis-based products for medicinal use in humans may only be supplied in specified circumstances. The product must either be a medicinal product with a marketing authorization under applicable medicines legislation, an investigational medicinal product supplied for use in the course of a clinical trial.
If an unlicensed medicine not supplied during a clinical trial, a so-called ‘special’ meeting the requirements for ‘specials’ set out in the Human Medicines Regulations 2012 and supplied in accordance with a prescription by a specialist doctor.
For Celadon, these three initial sales contracts follow its receipt of Good Manufacturing Practices (GMP) registration from the Medicines and Healthcare products Regulatory Agency (MHRA) in January 2023, and subsequent update to Celadon’s Home Office license in March 2023.
Short added: “Celadon’s focus on the highest standards of product quality is essential to meeting the high expectations of our customers, as well as building trust in the UK’s medical cannabis market. Pleasingly, we are already seeing strong levels of demand for our product and, supported by the high barriers to entry for new producers, we remain confident in our long-term growth prospects.”
NHS guidelines for prescribing state that there is no restriction in law for which indications cannabis-based products (CBPM) for medicinal use may be prescribed.
When prescribing CBPMs, it is a clinical decision to determine the most appropriate treatment option for a patient. The guidelines also say that those who prescribe will need to consider the patient’s values and preferences, their clinical condition, other medicines, the clinical evidence of efficacy and safety for the indication being considered, and the suitability of other licensed medicines.
There is the most evidence of clinical effectiveness in intractable nausea and vomiting, multiple sclerosis related spasticity and severe treatment-resistant epilepsy where licensed products are now available.