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Apremilast Film-Coated Tablets: DCP Status Update

16 June 2022

Adalvo is pleased to announce that our dossier for Apremilast Film-Coated Tablets is complete and our DCP submission is scheduled for January 2023. 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 these timelines, we believe we will be among the first companies to file in Europe.

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