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Adalvo announces successful Pivotal BE results for Mirabegron

22 February 2023

We are pleased to announce our successful Pivotal BE results for Mirabegron prolonged release tablets. We will proceed with DCP submission, which is scheduled for June 2023.

This product has been developed in collaboration with one of our strategic partners, based on the reference brand Betmiga prolonged release tablets. It is indicated in the treatment of urgency, increased micturition frequency and urgency incontinence.

The brand sold approximately $3052 Mn globally in 2021, with a Global 3Y CAGR of 8%, according to IQVIA.

Based on our positive progress and clearly defined IP pathways, we believe that we will be ready for launch on Day-1 in all major markets.

Adalvo is one of the few Companies able to complete this very difficult development of a complex product in the generic pharma space, which further showcases our ability to bring differentiated products to our partners, strengthening Adalvo's presence in the Urology segment.