Adalvo announces successful pivotal BE trial outcome of Drospirenone + Estradiol program

04 January 2021

We are happy to announce a positive pivotal PK outcome of our Drospirenone + Estradiol development which is our new milestone in creating Adalvo’s mission for a boutique portfolio containing complex and niche products. Adalvo is the only known developer of this asset which underpins our differentiated portfolio strategy.

Our bioequivalence study was carried out on Drospirenone 2mg + Estradiol 1mg film-coated tablet (Adalvo) and Angeliq® film-coated tablets (Bayer). Leveraging on our breakthrough results Adalvo will proceed to compile a generic dossier in the very near future. Having such a product in our basket is a great example of how to always aim for differentiated assets for our company.

Adalvo is targeting a generic and bioequivalent version of Angeliq® film-coated tablets that has been developed in collaboration with one of our third-party partners. Angeliq® is a hormonal drug sold by Bayer and is typically indicated for hormone replacement therapy for women in post-menopause. The brand is currently selling $70 million globally as reported by IQVIA.

Partner up now!

Adalvo is very excited about many other interesting products in development and the positive news on this product gives us even bigger reason to look forward to the bright future ahead of us. Please contact our BD Directors for your markets for further information. – FR, AT, CH, Nordics, GR, Canada, South Africa, Australia – MENA – ES, IT, DE, LATAM, – UK, PT, CEE CIS, RU, Brazil - APAC

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