Intervacc - Strangvac receives positive CVMP opinion

CVMP recommending approval of Strangvac in the EU Expect endorsement by the European Commission in Q3 Process for potential approval in the UK on-track A positive opinion paving the way for full approval… Based on its dossier including 102 horses and ponies, the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending approval of Strangvac within the EU. This is in-line with our expectations as we have estimated a 90% likelihood of approval. After a positive opinion it usually takes ~30 days to get final approval (max 67 days) by the European Commission (EC). … expecting full approval by the EC in Q3 Final EU approval in Q3’21 is set to enable access to one of Intervacc’s primary markets, with some 6 million horses where the company estimates that between 30-60% of horses are currently on vaccination programs such as equine influenza.

As we have covered in previous research, Intervacc have already established an exclusive distribution agreement with Dechra Pharmaceuticals to commercialise Strangvac in Europe-ex Nordics and Baltics where Intervacc will market and sell Strangvac directly. Positive opinion for use in the UK expected in July Intervacc notes that the process towards the approval of Strangvac for use in the UK is on-track and the company anticipates receiving a positive opinion before the end of July. The company also continues its preparations for marketing authorisation of Strangvac in the US.

The company expects a few local studies on horses to be required in the US, and that local production of the drug product (“fill finish”) may help the process. Aided by regulatory consultants, Intervacc estimates that the whole process will take ~18 months, implying potential US approval in late 2022.