On October 1, 2024 Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or associated companies, "Sun Pharma")) and Philogen S.p.A (BIT: PHIL) ("Philogen") reported that they have entered into a global licensing agreement for commercializing Philogen’s specialty product, Fibromun (L19TNF) (Press release, Philogen, OCT 1, 2024, View Source [SID1234646934]). Fibromun, an innovative anti-cancer immunotherapy, is being investigated in registration trials by Philogen for the treatment of soft tissue sarcoma and glioblastoma.
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Under the terms of the agreement, Sun Pharma will have the exclusive worldwide rights to commercialise Fibromun. Philogen will complete the ongoing pivotal clinical trials for the product, pursue Marketing Authorization with regulatory authorities, and manufacture commercial supplies. Sun Pharma will be responsible for commercialization activities. The two partner companies will share post-commercialization economics in about 45(Philogen):55(Sun Pharma) ratio. Other financial terms were not disclosed.
Dilip Shanghvi, Chairman and Managing Director of Sun Pharma, said, "Fibromun’s progress through development has been quite encouraging and it has 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."
Prof. Dr. Dario Neri, CEO and CSO of Philogen, commented: "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 commercialization of Fibromun, a new immunotherapy that has the potential to serve patients with soft tissue sarcoma and certain malignant forms of brain tumors (e.g., 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-tumor responses in a subset of patients. We have also announced that an independent monitoring board has evaluated safety and efficacy data of the pre-planned interim analysis of our Phase III clinical trial in soft tissue sarcoma and recommended continuing the study as planned by the protocol. In view of these promising developments, both companies are committed to the development and commercialization of Fibromun, making it widely available to patients who may benefit from it."
Previously, the two companies announced that on May 30, 2023, they entered into an Exclusive Distribution, License, and Supply Agreement for commercializing the specialty product Nidlegy in Europe, Australia and New Zealand. The first Marketing Authorization Application for Nidlegy has been submitted to European Medicines Agency (EMA) for the treatment of locally advanced, fully resectable melanoma in the neoadjuvant setting.
About Fibromun (L19TNF, onfekafusp alfa)
Fibromun is a biopharmaceutical product, proprietary to Philogen, studied for the treatment of advanced soft tissue sarcoma and glioblastoma. It consists of the L19 antibody genetically fused to Tumor Necrosis Factor (TNF). L19 binds selectively to the Extra Domain B of Fibronectin, a protein expressed in tumors (and other diseases) but absent in most healthy adult tissues. TNF is a cytotoxic cytokine with anti-tumor activity that is preferentially localized by the L19 antibody to neoplastic masses. L19TNF is administered via intravenous infusion. Late-stage clinical trials with registration potential are on-going in soft tissue sarcoma and glioblastoma. The product has pan-tumoral potential and could be explored for the therapy of other cancer types (e.g., lung, breast, colon, prostate cancers).