Sun Pharma's Partner Philogen Withdraws Marketing Authorization Application for Nidlegy™ in European Union

Philogen S.p.A, Sun Pharmaceutical Industries Limited's partner for the treatment of skin cancers in Europe, New Zealand and Australia, has voluntarily withdrawn the Marketing Authorization Application (MAA) for Nidlegy™. The decision was due to the timing of the availability of Chemistry Manufacturing and Controls (CMC) and additional clinical data. Nidlegy™, a biopharmaceutical product for the treatment of skin cancer, is currently being investigated in Phase III clinical trials for locally advanced melanoma and in Phase II clinical trials for High-Risk Basal Cell Carcinoma and other non-melanoma skin cancers. Philogen remains confident in the favorable benefit-risk profile of Nidlegy™ and plans to resubmit an updated application.