April 1, 2021: Zent2U announces completion of Sacubitril + Valsartan pivotal bioequivalence study.

Zent2U is happy to announce that after a successful pilot BE study conducted in 2020 we have recently completed also pivotal bioequivalence study. Our trial was carried out on Sacubitril + Valsartan film-coated tablets (Zentiva) and Entresto® film-coated tablets (Novartis®) and our endpoints perfectly matched required bioequivalence parameters.

Having clinical studies completed we reached a significant development milestone we‘ll progress into manufacturing of registration batches. We have successfully developed a technical solution that does not use the patented Sacubitril and Valsartan cocrystal and that will allow us and our customers to bring an Entresto® generic to the market at the earliest possible date. We expect to have the EU dossier completed and available for review by  Q4 2022. This target date is giving us and you sufficient buffer for European registration filing at data exclusivity expiry date in November 2023. We believe that having a dossier in place in 2022 grants Zent2U and its partners the great position to register the dossier in all major EU markets at earliest possible time and launch generic product to the cardiovascular blockbuster at day 1 after patent expiry.

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Media Contact

Mounira Lemoui
Head of Communications
ZENTIVA GROUP, a.s.
U kabelovny 529/16, Dolní Měcholupy, 102 00 Prague 10
Mobil: (+420) 727 873 159
E-mail: mounira.lemoui@zentiva.com