Animalcare Group PLC Daxocox receives positive opinion from CVMP in EU (6321P)
February 18 2021 - 10:43AM
UK Regulatory
TIDMANCR
RNS Number : 6321P
Animalcare Group PLC
18 February 2021
ANIMALCARE GROUP PLC
(the "Company" or the "Group")
Daxocox receives positive opinion from CVMP in Europe
18 February 2021. Animalcare Group plc (AIM: ANCR), the
international animal health business, has received a positive
opinion from the Committee for Medicinal Products for Veterinary
Use (CVMP) recommending a marketing authorisation for Daxocox
(enflicoxib) in Europe.
Daxocox is a novel COX 2 inhibitor and was filed for approval in
January 2020 for the treatment of pain and inflammation associated
with osteoarthritis (or degenerative joint disease) in dogs.
Following the CVMP's positive opinion, a marketing authorisation
decision from the European Commission is anticipated early in the
second quarter of 2021. If approved, the authorisation will be
valid in all member states of the European Union as well as Norway,
Liechtenstein and Iceland.
The equivalent regulatory review of Daxocox for the UK is
running largely in parallel with the European Union's schedule and
the Group expects a decision on UK marketing authorisation within
the same timeframe.
Jenny Winter, Chief Executive Officer said: "This is a hugely
important step in the journey to market for Daxocox, a product that
has the potential to play a leading role in the Animalcare growth
story. Subject to final approval, we plan to launch Daxocox across
European markets in the second half of 2021 and expect the product
to contribute to revenues before the end of the year."
The development programme for Daxocox is led and managed by the
Animalcare team under the pipeline project name, E-6087. Daxocox is
the sole property of Animalcare Group plc.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 596/2014.
About Animalcare
Animalcare Group plc is a UK AIM-listed international veterinary
sales and marketing organisation. Animalcare operates in seven
countries and exports to approximately 32 countries in Europe and a
further 16 worldwide. The Group is focused on bringing new and
innovative products to market through its own development pipeline,
partnerships and via acquisition.
For more information about Animalcare, please visit
www.animalcaregroup.com or contact:
Animalcare Group plc +44 (0)1904 487 687
Jenny Winter, Chief Executive Officer
Chris Brewster, Chief Financial
Officer communications@animalcaregroup.com
Media relations
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(Nominated Adviser & Joint Broker)
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(Joint Broker)
Corporate Finance
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Corporate Broking
Rupert Dearden +44 (0)20 7886 2500
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