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Sun Pharma and Philogen Ink a Licensing Deal for Nidlegy™

Sun Pharmaceutical Industries Limited, a leading global pharmaceutical company, and Philogen S.p.A, a pioneering biotechnology firm, have recently announced their licensing agreement to market Nidlegy™ (Daromun), Philogen's specialty product, in Europe, Australia, and New Zealand territories.



The Groundbreaking Product: Nidlegy™

Nidlegy™, an innovative anti-cancer biopharmaceutical, is currently in Phase III clinical trials. Philogen is developing it to treat both melanoma and non-melanoma skin cancers. It is a unique blend of two active ingredients, L19IL2 and L19TNF, which are independently manufactured and mixed before intralesional administration.

Nidlegy™ Composition

The L19 antibody in Nidlegy™ is specific to the Extra Domain B of Fibronectin, a protein that is expressed in tumors and certain other diseases but is 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 treating locally advanced melanoma, and in Phase II clinical trials for treating High-Risk Basal Cell Carcinoma and other non-melanoma skin cancers.

Key Elements of the Licensing Agreement

Under the agreement, Sun Pharma will have exclusive rights to commercialize Nidlegy™ for skin cancer indications in the territories of Europe, Australia, and New Zealand. Philogen will conclude pivotal clinical trials for the product in Europe, seek Marketing Authorization with the regulatory authorities, and handle the manufacture of commercial supplies.

Responsibilities of the Partners

Sun Pharma will lead commercialization activities. Post-commercialization economics will be shared between the two partner companies in approximately a 50:50 ratio. Further financial terms were not disclosed.

Philogen will retain the Intellectual Property rights for Nidlegy™ for other territories and indications other than skin cancers.

Sun Pharma's Perspective

Hellen De Kloet, Business Head - Western Europe and ANZ, Sun Pharma, expressed her delight about the partnership with Philogen for Nidlegy™. She stated that this partnership aligns with Sun Pharma's 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,” said Hellen De Kloet.

Philogen's Perspective

Prof. Dr. Dario Neri, CEO and CSO of Philogen, also shared his enthusiasm about the collaboration with Sun Pharma. He added that this collaboration will focus on the commercialization of Nidlegy™, a new immunotherapy that promises to enhance the therapeutic options for patients suffering from melanoma and non-melanoma skin cancers.

"Both companies are committed to the development and commercialization of Nidlegy™, making it widely available to patients who may benefit from it,” commented Prof. Dr. Dario Neri.

About Sun Pharmaceutical Industries Ltd.

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 enable it to deliver high-quality products at affordable prices, trusted by customers and patients in over 100 countries across the world.


About Philogen S.p.A

Philogen is an Italian-Swiss company active in the biotechnology sector, specializing in the research and development of pharmaceutical products for the treatment of highly lethal diseases. Their main therapeutic strategy is tumor targeting, which uses ligands capable of selectively delivering very potent therapeutic active ingredients to the tumor mass, sparing healthy tissues.

For more details, you can visit their website.

Final Thoughts

This partnership between Sun Pharma and Philogen brings hope for patients suffering from skin cancers, as Nidlegy™, an innovative product, is now one step closer to being accessible to patients across Europe, Australia, and New Zealand. The collaboration underscores both companies' commitment to improving patient outcomes and addressing unmet medical needs.

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