Malignant melanoma on the right upper medial back, marked for biopsy. Credit: Dermanonymous / commons.wikimedia.org.

Sun Pharmaceutical Industries has reached a licence agreement with Philogen for the commercialisation of Philogen’s Nidlegy (Daromun) in Australia, New Zealand and Europe.

Nidlegy is a new anti-cancer biopharmaceutical being developed to treat patients with melanoma and non-melanoma skin cancers. It is currently undergoing Phase III clinical studies.

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Nidlegy is composed of L19TNF and L19IL2, two active ingredients which are produced separately and then combined before being administered via the intralesional method.

Philogen CEO and CSO Professor Dr Dario Neri stated: “This collaboration will focus on the commercialisation 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.”

Sun Pharma has been granted exclusive commercialisation rights for Nidlegy in the three countries for the treatment of skin cancers.

Philogen will hold intellectual property rights for Nidlegy in other territories and indications, excluding skin cancers.

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It intends to conclude pivotal clinical studies for Nidlegy in Europe and to seek marketing authorisation from the regulatory authorities.

The company will also be involved in the manufacture of commercial supplies.

Sun Pharma will take responsibility for the commercialisation of the product.

Post-commercialisation costs will be split equally between the two companies.

Sun Pharma Western Europe and ANZ business head Hellen De Kloet stated: “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.”