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Dossier Readiness for Dalbavancin Injection planned by end 2022

21 November 2022

As we strengthen our injection product pipeline, we are pleased to announce dossier readiness for Dalbavancin Injection will be complete by the end of 2022.  We now proceed to dossier submission at a global level, and submission dates are already scheduled in 2023, following data exclusivity. We believe we will be among 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) / Dalvance (US), from Allergan, 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 positive status 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, including the EU and US.