Philogen and Sun Pharma Announce EMA Validation of Nidlegy™ Marketing Application

Philogen S.p.A. and Sun Pharmaceutical Industries Limited have announced the European Medicines Agency (EMA) has validated the submission of the Marketing Authorization Application (MAA) for Nidlegy™. This submission, finalized on June 3rd and validated on June 20th, marks a significant milestone in bringing Nidlegy™ to patients with locally advanced, fully resectable melanoma.

"The validation of the dossier by EMA represents the first important milestone for the MAA review process," said Dario Neri, CEO and CSO of Philogen. "Our group is committed to working with EMA throughout the review process with the goal of making Nidlegy™ available to patients in need."

Nidlegy™, a biopharmaceutical product developed by Philogen, is designed for the treatment of skin cancer. It consists of two active ingredients, L19IL2 and L19TNF, which are combined and administered intralesionally. The product is currently under investigation in Phase III clinical trials for melanoma and Phase II trials for other skin cancers.

The pivotal Phase III study, a multi-center, randomized trial, demonstrated that Nidlegy™ met its primary endpoint. These promising results were presented at ASCO on May 31, 2024. The study involved 256 patients across 22 clinical centers in Germany, Italy, France, and Poland, comparing the efficacy and safety of intratumoral injections of Nidlegy™ followed by surgery, against surgery alone.

Philogen, headquartered in Siena with a research center in Zurich, specializes in developing innovative cancer treatments. Their strategy involves using ligands to deliver potent payloads directly to tumor cells, sparing healthy tissues.

Sun Pharma, a leading global specialty generics company, partners with Philogen to bring Nidlegy™ to markets in Europe, New Zealand, and Australia. Sun Pharma is the largest pharmaceutical company in India and a key player in the US and global markets.

As the review process continues, the data from the Phase III Nidlegy™ trial is expected to be published in a peer-reviewed scientific journal later this year.