Sun Pharmaceutical Industries Ltd.

Sun Pharmaceutical Industries’ partner Philogen S.p.A (Philogen) has voluntarily withdrawn the application for marketing authorization to the European Medicines Agency (EMA) for Nidlegy, a biological investigational medicinal product which is intended to be used for the neoadjuvant treatment of adult patients with locally advanced fully resectable melanoma. Philogen’s candidate Nidlegy is partnered with Sun Pharmaceutical Industries for the treatment of Skin Cancers in Europe, New Zealand and Australia.

Philogen's decision to withdraw the Marketing Authorization Application (MAA) was due to the timing of the availability of Chemistry Manufacturing and Controls (CMC) and additional clinical data to better characterize the benefit:risk profile in patients with locally advanced resectable melanoma. Provision of the CMC and clinical data were unlikely to be completed within the current allowed timeframe.

Sun Pharmaceutical Industries (Sun Pharma) is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.