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2022-05-17| Licensing

Shionogi, F2G Inks $480 Million Pact to Market Oral Antifungal in Europe and Asia

by Joy Lin
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Invasive fungal infections are considered a significant public health issue in Europe and many parts of the world. Changes in the environment drive the increasing prevalence of fungal diseases such as dermatophytosis and aspergillosis. According to Market Data Forecast, the antifungal drugs market in Europe alone was valued at $3.52 billion in 2022, and will have a CAGR of 3.4% to reach $4.16 billion in 2027. 

To address the rising need for antifungal treatments, Japanese pharma Shionogi and Novo Holdings portfolio company F2G have agreed on a deal to develop and market F2G’s oral antifungal olorofim in Europe and Asia. The deal is estimated to be worth $480 million.

 

Antifungal for Invasive Aspergillosis 

 

Olorofim is a leading compound in F2G’s pipeline of a new class of antifungal agents called orotomides. It is administered orally to treat invasive aspergillosis (IA), a potentially fatal disease that mainly affects the immunocompromised, as well as other rare mold infections. 

When existing antifungal therapies fail or are unsuitable for use due to drug interactions, side effects and tolerability, olorofim may come into play. The drug acts differently from current antifungals, killing fungal infections via the inhibition of the pyramiding synthesis pathway. 

F2G claims that olorofim is the first of its class to be developed in 20 years and is the only antifungal to be granted Breakthrough Therapy Designation for multiple indications by the US FDA. 

Olorofim is currently undergoing a Phase 2b open-label study and a Phase 3 randomized study dubbed “Oasis”.  

Related article: The FDA Issued its First Formal Warning to Companies Selling Delta-8 THC Products

 

Terms of the Deal 

 

Under the collaboration, Shionogi will conduct clinical trials, registration and marketing of olorofim for IA in Europe and Asia. Shionogi will pay F2G $100 million upfront and up to $380 million in milestones, as well as double-digit royalties on net sales of olorofim. 

“By joining forces with Shionogi, we will be able to progress the development of olorofim with a partner which 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 Francesco Maria Lavino, CEO of F2G. Lavino added that the company is preparing to commercialize olorofim in the US.

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