REG - Celadon Pharma. PLC - Approval of GMP Registration by MHRA

Celadon PharmaceuticalsAnnouncement

16/01/2023 07:00

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RNS Number : 7538M  Celadon Pharmaceuticals PLC  16 January 2023

 

Celadon Pharmaceuticals Plc

 

("Celadon" or the "Company")

 

Approval of GMP Registration by MHRA

 

London, 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 Midlands UK
facility has now been registered by the UK Medicines and Healthcare products
Regulatory Agency ("MHRA") for the Good Manufacturing Practice ("GMP")
manufacturing of its cannabis Active Pharmaceutical Ingredient (API).

 

Highlights

·      GMP registration understood to be the first such registration of
a UK pharmaceutical facility for high Δ9-tetrahydrocannabinol ("THC")
cannabis API since the legalisation of medical cannabis in 2018

·      Celadon becomes one of a small number of companies globally with
the capability to produce an EU-GMP grade high-THC cannabinoid API

·      GMP registration and a Home Office licence is required in order
to sell high-THC medicinal cannabis in the UK. Celadon has notified the Home
Office to request an update to its existing licence to reflect its GMP status

·      GMP registration follows the seven harvests and extractions
during 2022 and the MHRA inspection in Q4 2022

 

GMP is the globally recognised quality standard that is required to
manufacture pharmaceutical medicines for human use and clinical trials. It is
an essential requirement for the commercialisation of Celadon's medicinal
cannabis product, which will be supplied in oil form as an API.

 

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. In the
UK currently, patients prescribed medicinal cannabis are reliant on imported
product, often facing lengthy delays and high costs.

 

Celadon's API is manufactured using a proprietary combination of genetics,
extraction technology and indoor hydroponic cultivation. Utilising the most
advanced controlled environment cultivation allows Celadon to achieve
pharmaceutical-level consistency, quality and replicability, having done seven
successful harvests to-date, resulting in an EU-GMP-grade product suitable for
human use.

 

Celadon's GMP product and its ongoing R&D programme, make the Company a
partner a choice for leading universities, government bodies and global
pharmaceutical companies undertaking cannabinoid R&D and drug development.

 

Celadon will require receipt of confirmation from the Home Office that they
have updated its current Home Office licence before they will be able to
supply its GMP API to third parties. The Company is informing the Home Office
of the receipt of its GMP registration. Celadon's current Home Office licence
permits it to legally grow high-THC medicinal cannabis for the purpose of
producing test batches of cannabis oil to support its application to the MHRA;
during 2022, Celadon achieved seven successful harvests. Whilst there is no
guarantee that the Home Office will update the current licence, nor any
timeframe for this, the Directors are confident that the licence will be
updated in due course. The Company has worked closely with the Home Office for
four years, including securing updates to its licence, and had the
conversation about updating the licence for GMP at the Home Office's last site
inspection.

 

James Short, Chief Executive Officer of Celadon said:

"With the receipt of GMP registration, Celadon has joined a very select group
of cannabis-focused pharmaceutical companies globally. This is a tremendous
milestone for the Company given the significant capital and regulatory
requirements in this sector.

 

"Today's announcement is the culmination of four years of hard work. I would
like to thank the team and our loyal shareholders for their support and belief
in our vision as we continue our journey of putting the patient first in
ensuring they can access the cannabis-based medicines they so desperately
need."

 

 

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 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.

 

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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