Sun Pharma Partners With Philogen's to Commercialize Skin Cancer Drug, Nidlegy in Europe, Australia & New Zealand

Sun Pharmaceutical Industries Limited (along with its subsidiaries and/or associated companies, "Sun Pharma") and Philogen S.p.A announced a licencing agreement for the commercialization of Philogen's specialty product, Nidlegy (Daromun), in Europe, Australia, and New Zealand. Nidlegy is a new anti-cancer biopharmaceutical being developed by Philogen for the treatment of melanoma and non-melanoma skin cancers. It is currently in phase III clinical trials.

Sun Pharma will have exclusive rights to commercialise Nidlegy for skin cancer indications in Europe, Australia, and New Zealand, according to the terms of the agreement. Philogen will conduct pivotal clinical trials in Europe, seek Marketing Authorization from regulatory authorities, and manufacture commercial supplies. Sun Pharma will be in charge of all commercialization activities. The two partner companies will split post-commercialization profits roughly 50:50. Other financial details were not provided.

Philogen will retain the intellectual property rights to Nidlegy in territories and indications other than skin cancers. "We are delighted to partner with Philogen for Nidlegy, a close to market, new immunotherapy treatment in skin cancers," said Hellen De Kloet, Sun Pharma's business head - Western Europe and ANZ. This collaboration is in line with our goal of providing patients with innovative products. We will be well-positioned to provide patient solutions across a broad spectrum of skin cancers in various disease stages with the expected addition of Nidlegy to our existing Odomzo franchise." Prof. Dr. Dario Neri, CEO and CSO of Philogen, commented: “We are pleased to establish a collaboration with Sun Pharma, a leading global pharmaceutical company, in the onco-dermatology space.

This collaboration will focus on the commercialization of Nidlegy, a new immunotherapy that brings promise to improve the therapeutic options for patients suffering from melanoma and non-melanoma skin cancers, high-risk conditions with unmet medical need. Both companies are committed to the development and commercialization of Nidlegy making it widely available to patients who may benefit from it.” Nidlegy is a biopharmaceutical product, proprietary to Philogen, designed for the treatment of skin cancer. It consists of two active ingredients, L19IL2 and L19TNF which are manufactured independently, and which are mixed prior to intralesional administration.

The L19 antibody is specific to the Extra Domain B of Fibronectin, a protein expressed in tumours (and other diseases) but absent in most healthy tissues. Interleukin 2 (IL2) and Tumour Necrosis Factor (TNF) are pro-inflammatory cytokines with anti-tumour activity. Nidlegy is currently being investigated in two phase III clinical trials for the treatment of locally advanced melanoma, and in phase II clinical trials for the treatment of high-risk basal cell carcinoma and other non-melanoma skin cancers. Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.

A vertically integrated business and a skilled team enables it to deliver high-quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Philogen is an Italian-Swiss company active in the biotechnology sector, specialized in the research and development of pharmaceutical products for the treatment of highly lethal diseases.