Celadon Pharmaceuticals PLC Successful Update to Home Office Licence (9563S)
15 March 2023 - 2:01AM
UK Regulatory
TIDMCEL
RNS Number : 9563S
Celadon Pharmaceuticals PLC
14 March 2023
Celadon Pharmaceuticals Plc
("Celadon" or the "Company")
Successful Update to Home Office Licence
Approval and Licence in place for commercial sale of GMP
pharmaceutical cannabis
London, 14 March 2023 - Further to the announcement dated 16
January 2023, Celadon Pharmaceuticals Plc (AIM: CEL) , a UK-based
pharmaceutical company focused on the research, cultivation,
manufacturing and sale of breakthrough cannabis-based medicines,
announces that its current Home Office licence has been
successfully updated to allow the commercial sale of its high
<DELTA>9-tetrahydrocannabinol ("THC") product, following the
Company's recent registration as a Good Manufacturing Practices
("GMP") manufacturer by the UK Medicines and Healthcare products
Regulatory Agency ("MHRA").
Highlights
-- Receipt of updated Home Office licence enables Celadon to
commence the commercial supply of its GMP pharmaceutical cannabis
product
-- GMP registration is understood to be the first such
registration of a UK pharmaceutical facility for high THC cannabis
active pharmaceutical ingredient ("API") since the legalisation of
medical cannabis in 2018
-- GMP registration and a Home Office licence are required in
order to sell high-THC medicinal cannabis in the UK
-- Celadon becomes one of a small number of companies globally
with the capability to produce an EU-GMP grade high-THC cannabinoid
API
As set out in the 16 January 2023 announcement, Celadon notified
the Home Office to request an update to its existing licence to
reflect its GMP status. Celadon has today received confirmation
from the Home Office that it has updated the Company's current
licence to reflect Celadon's new GMP status. Celadon now holds a
Home Office licence that enables it to commercially supply its GMP
pharmaceutical cannabis product to third parties.
The Directors believe Celadon has now become one of a limited
number of companies globally with the approvals in place to
cultivate and manufacture EU-GMP grade high-THC medicinal cannabis
and is understood to be the first for high-THC API in the UK since
medicinal cannabis was legalised in 2018. Within the UK, patients
prescribed medicinal cannabis are reliant on imported product,
often facing lengthy delays and high costs, and by becoming a
UK-based producer, Celadon is in a prime position to alleviate the
issues currently faced by patients.
James Short, Chief Executive Officer of Celadon said:
"Following our milestone GMP certification, our updated Home
Office licence now gives Celadon the opportunity to pursue revenue
through the sale of our medicines, and to becoming a partner of
choice in the pharmaceutical cannabis sector.
It has been a great start to 2023 for Celadon and we continue to
work hard to get our products to market and, most importantly, to
the patients that need our medicines most."
Enquiries:
Celadon Pharmaceuticals Plc
James Short Via Powerscourt
Arthur Wakeley
Canaccord Genuity Limited (Nominated
Adviser and Broker)
Bobbie Hilliam / Andrew Potts / Patrick
Dolaghan +44 (0)20 7523 8000
Powerscourt Group
Sarah MacLeod / Nick Johnson / Sam Austrums
/
Ibrahim Khalil +44 (0)20 7250 1446
About Celadon Pharmaceuticals Plc
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 is EU-GMP
approved and comprises indoor hydroponic cultivation, proprietary
GMP extraction and manufacturing and an analytical and R&D
laboratory. Celadon's Home Office licence allows for the commercial
supply of its GMP pharmaceutical cannabis product. 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.
For further information please visit our website
www.celadonpharma.co.uk
This announcement contains inside information for the purposes
of article 7 of the Market Abuse Regulation (EU) 596/2014 as
amended by regulation 11 of the Market Abuse (Amendment) (EU Exit)
Regulations 2019/310. With the publication of this announcement,
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