EC grants orphan drug designation to Philogen SpA for the treatment of soft tissue sarcoma.

Release Date: 28-Nov-2016

Philogen SpA, a clinical stage biological company dedicated to develop and commercialize immunology and immune-oncology protein therapeutics, declared that European commission has granted orphan drug designation to L19TNF - a non-covalent trimer of tumor necrosis factor (TNF) fused to an antibody specific to the extra-domain B of fibronectin in single-chain variable fragment format - for the treatment of soft-tissue sarcoma. Soft tissue sarcoma is estimated to affect approximately 2.8 in every 10,000 people in Europe and possess 5year survival rate of 58% for patients suffering from STS.



The EC decision is based on a recommendation by the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP). Orphan Drug Designation is granted for medicinal products that are intended for the diagnosis, prevention or treatment of rare diseases affecting less than 5 in 10,000 people in the European Union (EU). The Orphan Medicinal Product status of L19TNF entails a number of incentives, including 10-year market exclusivity once the product receives marketing authorisation.


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