Dalbavancin: Dossier Readiness In Q4 2022

13 April 2022

As we strengthen our injection product pipeline, we are pleased to provide a status update on our development of Dalbavancin. The development of this complex niche generic is progressing very well. Both our EU and US dossiers will be complete by Q4 2022 and we will progress with filing in early 2023. We believe we will be among the few players able to offer a dossier for both target regions, within Day-1 filing.

Our 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 $180mio globally in 2021, with Global 3Y CAGR at +40%, 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.

Disclaimer: Dalbavancin which is subject to patent protection is currently not offered or made available in countries where patents are in force