Zent2U is delighted to announce the successful completion of the pivotal bioequivalence trial that was conducted under fasting conditions. Our trial was carried out on Apremilast 30mg film-coated tablets (Zentiva) and Otezla® 30mg film-coated tablets (Amgen) and our endpoints perfectly matched the necessary bioequivalence parameters.
The completion of this bioequivalence study enables us to reach a significant milestone in terms of development. We will progress into manufacturing registration batches and compilation of EU dossiers which will be available for review in October 2021.
This target date is giving sufficient time for registration filing on the data exclusivity expiry date in January 2023. We believe that having a dossier in place in 2021 grants Zent2U and its partners the great position to register this dossier in all major European markets at the earliest possible time, and therefore launch the product indicated for psoriasis and psoriatic arthritis on Day 1 after patent expiry.
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Tomas PilarcikKey Account Manager
Thomas KoeneHead of Growth Partnerships
Head of Communications
ZENTIVA GROUP, a.s.
U kabelovny 529/16, Dolní Měcholupy, 102 00 Prague 10
Mobil: (+420) 727 873 159