11 November 2021
Adalvo is delighted to announce that we successfully completed our Pivotal BE study of Nintedanib 100mg & 150mg soft gel capsules. We are now moving ahead into dossier completion, and will proceed with regulatory submission, upon exclusivity expiry.
Our product has been developed based on two reference brands: Ofev® 100mg & 150mg soft gel capsules which is indicated for the treatment of Idiopathic Pulmonary Fibrosis and Vargatef 100mg & 150mg soft gel capsules which is indicated in the treatment of Non-Small Cell Lung Cancer. Both brands sell at around $2.4bn annually, at a global level, combined. (according to IQVIA)
Our development is fully driven by Alvogen and is being developed at our Lotus site, Alvogen's Taiwanese state-of-the-art facility.
Based on our positive results, we expect to be amongst the first-to-file / first-to-market companies in all our major markets, with both indications.