Novo Holdings Portfolio Company F2G enters strategic collaboration with Shionogi to commercialise its new antifungal agent Olorofim in Europe and Asia

• Deal value includes upfront payment of US$100 million with F2G eligible for additional regulatory and commercial milestones of up to US$380 million, as well as double-digit royalties on net sales and share development costs
• Validation of Novo Holdings’ strategy to identify and invest in promising European biotech opportunities

Copenhagen, Denmark

Novo Holdings A/S, a leading international life sciences investor, today announces that its portfolio company F2G Ltd. (F2G) has entered into a strategic collaboration with Shionogi & Co., Ltd. (Shionogi) to develop and commercialise its antifungal agent olorofim for invasive fungal infections, in Europe and Asia.

F2G is a UK, US and Austria based biotech company focused on the discovery and development of novel therapies to treat life-threatening invasive fungal infections. Novo Ventures, the venture capital team at Novo Holdings, has led and participated in a series of financings since 2016. Naveed Siddiqi, Senior Partner at Novo Holdings, serves as a Board Member of F2G and Eric Snyder, Partner at Novo Holdings, as Board Observer.

Olorofim is a novel oral antifungal therapy developed by F2G to treat invasive aspergillosis (IA) and other rare mold infections. Olorofim works through a unique mechanism of action, different from all existing classes of antifungals, exerting fungicidal activity through inhibition of the pyrimidine synthesis pathway. Olorofim represents the first truly novel antifungal class developed in the past 20 years and is the only antifungal medication to be awarded a Breakthrough Therapy Designation (BTD) for multiple indications by the US Food & Drug Administration (FDA).

The world market for antifungal agents is currently worth in excess of US$6 billion with consistent annual growth driven by year-on-year increases in the susceptible immune compromised patient population. Increases in cancer, organ transplants and use of potent drugs, including broad spectrum antibiotics has led to significant increases in fungal infections. Fungi are now recognised as a major issue in several respiratory conditions, being responsible for exacerbations of symptoms in asthma, COPD and bronchiectasis patients. This is likely to increase the use of antifungal drugs over the coming years. F2G believes that its novel agent, olorofim, and subsequent agents, will address some of the many challenges which face the treating physician and the patient with invasive fungal infections.

Olorofim is currently in a Phase 2b open-label study and Phase 3 randomized study (“OASIS”).

Naveed Siddiqi, Board Director of F2G and Senior Partner, Novo Holdings, said: “Globally there is a high unmet medical need for novel antifungal therapies that are active against resistant and refractory infections and also against pathogenic fungal species which have been difficult to successfully treat historically. F2G is developing a completely new class of antifungal agents called the orotomides.  The strategic collaboration with Shionogi is an exciting development for the Company as it offers the prospect of olorofim, once approved,  to reach even more patients around the world. This is Novo Ventures’ second anti-infective investment in 2022 that has attracted interest from partners in the pharmaceutical industry.”

Francesco Maria Lavino, Chief Executive Officer of F2G, said: “This collaboration will enable us to progress the development of olorofim with a regional partner.  Shionogi has a proven track record in both global drug development and business development and we look forward to working closely together while we now concentrate our efforts on the development and commercialisation of olorofim for the US market.”

Since January 2020, Novo Ventures has helped deploy over US$1.1 billion in life science investments.  The team consists of highly experienced investment professionals who operate from Copenhagen, Boston, London and San Francisco. The team advises on investments in early-stage startups through later stage crossover financings.  On the public side, the team helps catalyse IPOs and follow-on financings as well as participation in the open market.