Sun Pharmaceutical Industries Limited (Sun Pharma) and Philogen S.p.A. (Philogen) have entered an exclusive global commercialisation, licensing, and supply agreement for Fibromun (L19TNF), an advanced anti-cancer immunotherapy. According to the agreement, Sun Pharma will hold exclusive global rights to commercialise Fibromun, while Philogen will lead clinical trials, seek regulatory approvals, and handle manufacturing.
Fibromun is currently in late-stage registration trials for soft tissue sarcoma and glioblastoma, two aggressive cancers with limited treatment options and significant unmet medical needs. The collaboration highlights a shared commitment to advancing cancer care. Sun Pharma and Philogen have agreed to split post-commercialisation economics, with Sun Pharma receiving 55 per cent and Philogen 45 per cent. Additional financial details were not disclosed.
Dilip Shanghvi, Chairman and Managing Director of Sun Pharma, expressed confidence in Fibromun’s potential, saying, “The development of Fibromun has been promising, and we believe it could become an important treatment option for soft tissue sarcomas and other cancers that currently have few effective therapies. This partnership strengthens our oncology pipeline, particularly in alignment with our work in skin cancer treatments. We are eager to bring this therapy to patients globally.”
Philogen’s CEO and CSO, Prof. Dr. Dario Neri, also emphasised the positive clinical data. “We are pleased to expand our partnership with Sun Pharma. Data from our trials has demonstrated that Fibromun holds significant therapeutic promise, particularly in treating glioblastoma, where some patients have experienced long-lasting anti-tumor responses,” Neri stated. He further noted that an independent monitoring board had recommended the continuation of the Phase III trial for soft tissue sarcoma following a pre-planned interim analysis, reflecting the drug’s positive results thus far.
This collaboration marks the second between Sun Pharma and Philogen. Earlier, in May 2023, both companies partnered to commercialise Nidlegy, a treatment for locally advanced melanoma, across Europe, Australia, and New Zealand. The first Marketing Authorisation Application (MAA) for Nidlegy has already been submitted to the European Medicines Agency (EMA).
As Sun Pharma expands its oncology portfolio, the company aims to make Fibromun widely available to patients worldwide, providing a crucial treatment option in areas of high unmet need.
(ANI)