Nidlegy, currently in Phase III clinical trials, is a new anti-cancer biopharmaceutical which is being developed by Philogen for the treatment of melanoma and non-melanoma skin cancers. 

Sun Pharmaceutical Industries has entered into a licensing agreement for commercializing Philogen’s Nidlegy (Daromun) in the territories of Europe, Australia and New Zealand. 

Nidlegy, currently in Phase III clinical trials, is a new anti-cancer biopharmaceutical which is being developed by Philogen for the treatment of melanoma and non-melanoma skin cancers. 

Under the terms of the agreement, Sun Pharma will have exclusive rights to commercialise Nidlegy for indications of skin cancers in the territories of Europe, Australia and New Zealand. Philogen will complete pivotal clinical trials for the product in Europe, pursue Marketing Authorization with the regulatory authorities and manufacture commercial supplies. Sun Pharma will be responsible for commercialization activities. The two partner companies will share post-commercialization economics in about 50:50 ratio. Other financial terms were not disclosed. 

Philogen will retain the IP rights for Nidlegy for other 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. This collaboration is in line with our goal to bring innovative products to patients. With the expected addition of Nidlegy to our existing Odomzo franchise, we will be well-positioned to provide patient solutions across a broad spectrum of skin cancers in various disease stages,” says Hellen De Kloet, Business Head -Western Europe and ANZ at Sun Pharma, in a news release.

Prof. Dr. Dario Neri, CEO and CSO of Philogen, adds: “We are pleased to establish a collaboration with Sun Pharma, a leading global pharmaceutical company, in the oncodermatology 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 consists of two active ingredients, L19IL2 and L19TNF, which are manufactured independently and mixed prior to intralesional administration. The L19 antibody is specific to the Extra Domain B of Fibronectin, a protein expressed in tumors (and other diseases) but absent in most healthy tissues. Interleukin 2 (IL2) and Tumor Necrosis Factor (TNF) are pro-inflammatory cytokines with anti-tumor 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.