New Delhi [India], October 1 : Sun Pharmaceutical Industries Limited (Sun Pharma) and Philogen S.p.A (Philogen) announced a global exclusive commercialisation, licence, and supply agreement to commercialise Fibromun (L19TNF), Philogen's speciality anti-cancer immunotherapy product.
Fibromun is currently being investigated in registration trials for the treatment of soft tissue sarcoma and glioblastoma, both of which represent areas with significant unmet medical needs.
Under this agreement, Sun Pharma will hold exclusive global rights to commercialise Fibromun, while Philogen will continue conducting pivotal clinical trials, pursue marketing authorisation from regulatory bodies, and manufacture the product.
The two companies have agreed to share post-commercialization economics in a 45 per cent (Philogen) to 55 per cent (Sun Pharma) split. Financial details beyond these terms were not disclosed.
Fibromun is an innovative immunotherapy designed to target soft tissue sarcoma and glioblastoma, two forms of cancer that currently have limited therapeutic options.
According to Dilip Shanghvi, Chairman and Managing Director of Sun Pharma, "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."
He added, "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, stated, "We are pleased to extend our collaboration with Sun Pharma. Our data has shown that Fibromun has promising therapeutic activity, especially in glioblastoma, inducing long-lasting anti-tumor responses in some patients."
Neri added, "An independent monitoring board has also recommended the continuation of our Phase III clinical trial in soft tissue sarcoma following a pre-planned interim analysis. Both companies are committed to making Fibromun widely available to patients who may benefit from it."
This is the second collaboration between Sun Pharma and Philogen, following their May 30, 2023 agreement to commercialize Nidlegy, a specialty product aimed at treating locally advanced melanoma, in Europe, Australia, and New Zealand. The first Marketing Authorization Application for Nidlegy has already been submitted to the European Medicines Agency (EMA).
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