Celadon Pharmaceuticals PLC Approval of GMP Registration by MHRA (7538M)
January 16 2023 - 1:00AM
UK Regulatory
TIDMCEL
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
<DELTA>9-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
/
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 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
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