Biopharmaceutical company Gossamer Bio and Italian pharma Chiesi Group have announced a potential $486m global collaboration and licensing deal to develop Seralutinib.

Seralutinib is an inhaled PDGFRα/β, CSF1R, and c-KIT inhibitor. It is designed to be administered through dry powder inhaler to potentially treat pulmonary hypertension (PH).

The therapy is currently in late-stage PROSERA study which started in 2023. It was based on a positive readout of the Phase 2 TORREY trial in pulmonary arterial hypertension (PAH) patients.

Additionally, both firms plan to launch a worldwide Phase 3 registration trial for PH associated with interstitial lung disease (PH-ILD) by mid-2025. Gossamer and Chiesi will also assess Seralutinib`s efficacy in other areas with unmet medical needs.

Under the deal, Gossamer Bio and Chiesi Group will develop and commercialise Seralutinib in PAH, PH-ILD & other indications.

Gossamer Bio co-founder, chairman and CEO Faheem Hasnain said: “This partnership with Chiesi allows us to meaningfully deepen and rapidly accelerate our investment in Seralutinib as a potential treatment for PAH, PH-ILD, and other indications of high unmet medical need.”

According to the terms of the agreement, the biopharmaceutical company will lead the global development of seralutinib for PAH and PH-ILD.

Development costs will be split evenly between the companies, except for the PROSERA Study, where Gossamer will bear the financial responsibility alone.

In the US, commercial profits and losses will be shared equally between the companies. Gossamer Bio will spearhead commercialisation efforts and manage sales for PAH and PH-ILD in the US, with both parties contributing equally.

However, the Italian drug maker will take the lead in commercialising Seralutinib for additional indications in the US.

Outside the US, Chiesi will hold exclusive commercialisation rights for Seralutinib and will pay Gossamer a royalty in the mid-to-high teens range based on net sales.

Gossamer will receive a $160m development reimbursement from Chiesi. In addition, the biopharmaceutical firm is entitled to get $146m in regulatory milestones and $180m in sales milestones.

Chiesi Group CEO Giuseppe Accogli said: “Seralutinib is a potential paradigm-shifting therapy in PAH and PH-ILD, and we could not be more excited to partner with Gossamer to develop and bring this therapy to patients worldwide.”