REG - Animalcare Group PLC - Daxocox receives positive opinion from CVMP in EU
RNS Number : 6321PAnimalcare Group PLC18 February 2021ANIMALCARE 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
Jenny Winter, Chief Executive Officer
Chris Brewster, Chief Financial Officer
Media relations
+44 (0)1904 487 687
communications@animalcaregroup.com
Stifel Nicolaus Europe Limited
(Nominated Adviser & Joint Broker)Ben Maddison
Fred Walsh
Nick Adams
+44 (0)20 7710 7600
Panmure Gordon
(Joint Broker)
Corporate Finance
Freddy Crossley/Emma Earl
Corporate Broking
Rupert Dearden
+44 (0)20 7886 2500
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