Shionogi and F2G have partnered to develop and commercialise the new antifungal agent olorofim – formerly F901318 – for invasive fungal infections in Europe and Asia.
F2G developed olorofim as a novel oral antifungal therapy to treat invasive aspergillosis (IA) and other rare mould infections that can cause life-threatening infections, where available treatments have been ineffective.
Olorofim is currently in a phase 2b open-label study, focusing on rare and resistant invasive fungal infections, including invasive aspergillosis, a fungal infection caused by the Aspergillus species of mould. It also covers azole-resistant strains, coccidioidomycosis and scedosporiosis (including lomentosporiosis).
The treatment has already been granted orphan drug status by the European Medicines Agency (EMA) and orphan drug status, Qualified Infectious Disease Product (QIDP) designation.
It is the first novel antifungal treatment created in the last 20 years and is the only medication of its kind to have been given a Breakthrough Therapy designation from the US Food and Drug Administration.
According to the terms of the deal, Shionogi will conduct the clinical trials and subsequent registration and commercialisation of olorofim for IA in Europe and Asia. F2G will receive an upfront payment of $100m from Shionogi and share development costs in global studies.
Addtionally, F2G will qualify for additional regulatory and commercial milestones of up to $380m, alongside royalties on net sales.
“By joining forces with Shionogi, we will be able to progress the development of olorofim with a partner that has a proven track record in both global drug development and business development to effectively deliver a potentially life-saving therapy to patients globally,” said CEO of F2G, Francesco Maria Lavino.
For most people, many of these moulds are harmless. However, Aspergillus is spread to humans through inhalation, and has the potential to cause a range of disease, especially to those who are immunocompromised.
Isao Teshirogi, CEO of Shionogi, said: “We will continue to address unmet medical needs in infectious diseases and work towards total care for this area. As part of this mission and through our partnership with F2G, we hope to be able to provide new antifungal drugs to patients to protect people’s health from life-threatening, invasive fungal infections.”