Deal gives Shionogi access to BioVersys’ BV500 program targeting serious non-tuberculous mycobacterial infections

Japanese pharma company Shionogi has entered a global research and licensing agreement worth up to a potential CHF 484 million (€498 million) with Swiss biotech BioVersys to co-develop novel treatments for non-tuberculous mycobacteria (NTM) infections — a rare but increasingly prevalent disease with limited treatment options and growing drug resistance.

The agreement grants Shionogi access to BioVersys’ proprietary BV500 program and Ansamycin Chemistry platform, with the companies aiming to develop new therapies for patients facing difficult-to-treat mycobacterial infections. NTM diseases are increasingly recognised as a serious global health challenge, particularly for immunocompromised individuals and those with underlying lung conditions.

BioVersys will receive CHF 5 million (€5.15 million) in upfront and near-term research payments. If Shionogi exercises its exclusive license option, the Swiss biotech could earn an additional CHF 479 million (€493 million) in regulatory and commercial milestone payments, along with tiered royalties on future global sales.

The BV500 program has delivered several orally bioavailable lead candidates with broad-spectrum activity against NTM, including in vivo efficacy and a lack of cross-resistance with existing drug classes. The compounds, developed by BioVersys’ teams in Lille and Basel, have demonstrated strong preclinical potential and could represent a new class of therapeutics in the AMR space.

Marc Gitzinger, CEO and co-founder of BioVersys, commented: “This collaboration helps de-risk R&D while expanding the reach of our anti-infectives pipeline. Shionogi is a strong strategic partner, well-positioned to accelerate BV500 through clinical development and into global markets. Importantly, this partnership allows us to maintain financial discipline as we prepare to launch the Phase 3 trial for our lead program, BV100, later this year.”

John Keller, PhD, Senior Vice President at Shionogi, said: “We are pleased to join forces with BioVersys to address urgent unmet needs in infectious disease. The BV500 program has the potential to offer patients a best-in-class option for NTM infections, and we look forward to bringing our expertise to bear on its development.”

The collaboration builds on earlier work conducted within the SmartLab public–private partnership with the University of Lille and has benefited from support via the CF AMR Syndicate and the EU IHI-funded RespiriNTM programme. These partnerships will continue as the project advances.

The joint research team aims to deliver clinical candidates and back-up molecules during the initial phase of collaboration. Shionogi retains exclusive rights to license selected molecules for global clinical development and commercialisation.