REG - Celadon Pharma. PLC - Successful Update to Home Office Licence

Celadon PharmaceuticalsAnnouncement

14/03/2023 15:15

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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
Δ9-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 /             +44 (0)20 7250 1446

 Ibrahim Khalil

 

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
(http://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, this information is now considered to be in the public
domain.

 

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