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Adalvo announces successful dossier submission for Dalbavancin powder

24 February 2023

Adalvo is pleased to announce the successful EU dossier submission for Dalbavancin powder. This achievement further strengthens our infectiology product pipeline and positions Adalvo amongst the few players able to offer a dossier, within Day-1 filing.

This complex antibiotic niche product has been developed based on the reference brand Xydalba (EU), from Abbvie, and is indicated in the treatment of acute bacterial skin and skin structure infections. The product sold at $183mio globally in 2021, with Global 3Y CAGR at 22%, according to IQVIA.

The successful development of this product further highlights our ability to offer difficult-to-make, high-value products to our partners, as we venture into this niche antibiotic segment. We expect to launch this product on Day-1 in all major markets.

Adalvo is also preparing for Day- 1 filing of Dalbavancin in the US which is scheduled for May 2023.

We are also able to offer additional infectiology dossiers, as depicted below: