Chiesi Farmaceutici and Gossamer Bio Inc have entered into a global collaboration and license agreement to develop and commercialise seralutinib for the treatment of pulmonary hypertension.
The global collaboration combines the strengths of both Chiesi and Gossamer to support ongoing work in pulmonary arterial hypertension (PAH).
The work will accelerate the development of pulmonary hypertension associated with interstitial lung disease (PH-ILD), with the aim of expanding the seralutinib franchise to reach more patients with pulmonary hypertension worldwide.
Patients will benefit from Chiesi’s expertise in global respiratory, rare disease, and inhaled drug development and commercialisation. They will also benefit from Gossamer’s world-class PAH and PH-ILD development and commercialisation teams.
“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,” said Giuseppe Accogli, CEO of Chiesi Group.
“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,” said Faheem Hasnain, Co-Founder, Chairman and CEO of Gossamer.
Evaluating seralutinib
Seralutinib is an inhaled PDGFRα/β, CSF1R, and c-KIT inhibitor designed to be delivered via dry powder inhaler for the potential treatment of pulmonary hypertension.
Following the positive readout of the Phase 2 TORREY Study in patients with PAH, Gossamer initiated the Phase 3 PROSERA Study in 2023.
Gossamer and Chiesi plan to initiate a global Phase 3 registrational study in PH-ILD in mid-2025 and to evaluate seralutinib in additional indications of high unmet medical need.
Terms of the agreement
Under the terms of the agreement, Gossamer will continue to lead the global development of seralutinib in PAH and PH-ILD. The companies will evenly split development costs, except with respect to the PROSERA Study, for which Gossamer will remain financially responsible.
In the US, the companies will evenly share commercial profits and losses. Gossamer will lead US commercialisation, including contributing 50% of commercial activities and booking of sales for PAH and PH-ILD.
Chiesi will lead US commercialisation for additional indications. Chiesi will have the exclusive right to commercialise seralutinib outside of the US and will pay Gossamer an escalating mid-to-high teens royalty on net sales outside of the US.
Chiesi will pay Gossamer $160m as a development reimbursement.
Additionally, Gossamer will be eligible to receive up to $146m in regulatory milestones and $180m in sales milestones.
Chiesi: Advancing treatments for respiratory diseases
Chiesi is devoted to advancing research, exploration, and advancement of groundbreaking treatments in the field of respiratory diseases.
This collaboration introduces a significant and valuable addition to Chiesi’s research and development portfolio.
It aligns perfectly with the company’s strategy of bringing innovative treatments to patients with unmet needs and supporting the healthcare community through transformative solutions.
