Adalvo announces successful Pivotal BE outcome of Apremilast

29 March 2022

We are pleased to announce that we have now completed our Pivotal BE program for Apremilast Film-Coated Tablets. This product has been developed in collaboration with one of our strategic partners.

Our product has been developed based on the reference brand Otezla Film-Coated Tablets, which is indicated in the treatment of Psoriatic Arthritis and Psoriasis, and currently represents one of the few comfortable and compliant oral treatments for this disease. The brand sold approximately $3.5bn globally in 2021, having a significant growth potential with Global 3Y CAGR at 15%, according to IQVIA.

Based on our positive result we now progress with dossier completion, and we believe we will be among the first companies to file in Europe, which is expected on day 1, as soon as regulatory exclusivity expires.