Chiesi and Gossamer Bio Collaborate Globally on Seralutinib for Pulmonary Arterial Hypertension and Respiratory Conditions

Chiesi Farmaceutici and Gossamer Bio have announced a strategic global collaboration to develop and commercialize seralutinib, a promising treatment for pulmonary hypertension. This partnership aims to leverage Chiesi’s expertise in respiratory medicine and Gossamer’s proficiency in developing pulmonary hypertension therapies.

As part of the agreement, Gossamer will receive $160 million for development reimbursement and could potentially earn up to $146 million in regulatory milestones and $180 million in sales milestones. Additionally, the companies will share commercial profits equally in the U.S., splitting global development costs. Outside the U.S., Chiesi will have exclusive rights to develop, manufacture, and commercialize seralutinib, and Gossamer will receive mid-to-high teens royalties on net sales.

The collaboration is set to accelerate ongoing efforts in pulmonary arterial hypertension (PAH) and launch new initiatives for pulmonary hypertension associated with interstitial lung disease (PH-ILD). A Phase 3 trial for seralutinib in PH-ILD is planned for mid-2025, complementing the ongoing Phase 3 trial in PAH. This move could potentially provide a groundbreaking treatment for patients globally.

Giuseppe Accogli, CEO of Chiesi Group, expressed enthusiasm about the partnership, highlighting its potential to bring innovative therapies to patients worldwide. He emphasized Chiesi’s commitment to using innovation for global health improvements. Similarly, Faheem Hasnain, CEO of Gossamer, noted that the collaboration would significantly bolster their investment in seralutinib, particularly for conditions with high unmet medical needs like PH-ILD.

Seralutinib is an inhaled inhibitor targeting PDGFRα/β, CSF1R, and c-KIT, designed for delivery via a dry powder inhaler. It showed positive results in the Phase 2 TORREY Study for PAH, leading to the initiation of the Phase 3 PROSERA Study in 2023. The upcoming global Phase 3 trial in PH-ILD will further evaluate seralutinib's potential to treat various indications with high unmet medical needs.

Under the agreement terms, Gossamer will continue to lead the global development of seralutinib for PAH and PH-ILD, covering the costs for the PROSERA Study. In the U.S., both companies will share commercial profits and losses equally, with Gossamer overseeing U.S. commercialization efforts, including 50 percent of commercial activities and sales booking for PAH and PH-ILD. Chiesi will lead U.S. commercialization for any additional indications and will handle global commercialization outside the U.S., paying Gossamer royalties on net sales.

Chiesi is committed to advancing research and developing innovative treatments for respiratory diseases, which aligns with its strategic goals. This collaboration enhances Chiesi’s research and development portfolio, supporting its mission to address unmet medical needs and provide transformative healthcare solutions.

Chiesi Group is an international biopharmaceutical company focused on respiratory health, rare diseases, and specialty care. With a mission to improve quality of life and act responsibly towards the community and environment, Chiesi became a Benefit Corporation in several countries, emphasizing its commitment to creating shared societal value. Certified as a B Corp since 2019, Chiesi aims to achieve Net-Zero greenhouse gas emissions by 2035. Headquartered in Parma, Italy, Chiesi has over 7,000 employees and operates 31 affiliates worldwide, with significant research and development centers in various countries.

Gossamer Bio is a clinical-stage biopharmaceutical company dedicated to developing and commercializing therapies for pulmonary arterial hypertension, aiming to improve patient lives and become a leader in the industry.