Sun Pharma and Philogen sign global licensing agreement for Fibromun

Sun Pharmaceutical Industries and Philogen S.p.A. have announced a global licensing agreement for the commercialisation of Philogen’s specialty product, Fibromun. Fibromun, an anti-cancer immunotherapy, is being investigated in registration trials for the treatment of soft tissue sarcoma and glioblastoma.

Under the terms of the agreement, Sun Pharma will have exclusive worldwide rights to commercialise Fibromun. Philogen will complete ongoing pivotal clinical trials, pursue marketing authorisation with regulatory authorities, and manage the manufacturing of commercial supplies. Sun Pharma will be responsible for all commercialisation activities. The post-commercialisation economics will be shared, with Philogen receiving 45 per cent and Sun Pharma 55 per cent. Further financial details were not disclosed.

Dilip Shanghvi, Chairman and Managing Director of Sun Pharma, stated, “Fibromun’s progress through development has been quite encouraging, and it has the potential to be an important option for treatment of soft-tissue sarcomas and other cancers with significant unmet medical needs. This partnership expands our clinical pipeline into oncology in alignment with our current portfolio in skin cancers. We keenly look forward to providing this treatment option globally in due course of time.”

Professor Dr Dario Neri, CEO and CSO of Philogen, added, “We are pleased to extend our collaboration with Sun Pharma, a leading global pharmaceutical company, from our existing partnership on Nidlegy to Fibromun. This collaboration will focus on the global commercialisation of Fibromun, a new immunotherapy that has the potential to serve patients with soft tissue sarcoma and certain malignant forms of brain tumours, such as glioblastoma, for which limited therapeutic alternatives exist. Our group has published data reflecting the promising therapeutic activity of Fibromun in glioblastoma, inducing long-lasting anti-tumour responses in a subset of patients.”

Dr Neri further commented that an independent monitoring board had evaluated the safety and efficacy data of a Phase III clinical trial in soft tissue sarcoma and recommended continuing the study as per protocol. Both companies are committed to the development and global availability of Fibromun for patients who may benefit from it.

In a previous agreement on May, 30, 2023, Sun Pharma and Philogen announced an Exclusive Distribution, License, and Supply Agreement for the commercialisation of the specialty product Nidlegy in Europe, Australia, and New Zealand. The first Marketing Authorisation Application for Nidlegy has been submitted to the European Medicines Agency for the treatment of locally advanced, fully resectable melanoma in the neoadjuvant setting.