F2G Ltd, a UK Biotech developing novel therapies for life threatening fungal infections, has announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products has granted orphan drug status to its lead clinical candidate, F901318, for the treatment of invasive Aspergillosis and rare mould infections caused by Scedosporium species.
Orphan drug designation will allow F901318 up to ten years market exclusivity following market authorisation in the EU.
F901318 is the first member of a novel class of systemic antifungal agents targeting life threatening mould infections and acting through a completely novel cellular target.
F901318 is being developed for both intravenous and oral formulations and will enter Phase II clinical development in mid-2017.
Dr John H. Rex, Chief Medical Officer, F2G Ltd, said: “Given the global acknowledgement of increasing resistance of moulds to the azole antifungal class, we are delighted that the EMA has granted orphan drug status to F901318. We believe this agent will offer important therapeutic options to clinicians treating these deadly infections.”
Receiving the European orphan drug designation for F901318 offers certain benefits and incentives, including marketing exclusivity, that are strategically important from a regulatory and commercial perspective
Ian Nicholson, Chief Executive Officer, F2G Ltd, added: “Receiving the European orphan drug designation for F901318 offers certain benefits and incentives, including marketing exclusivity, that are strategically important from a regulatory and commercial perspective. The positive decision of the EMA orphan drug committee is further validation of F901318 and our development program as we look forward to accelerating our Phase II clinical programme this year. ”