Chiesi bets up to $486M on Gossamer pulmonary hypertension drug
Phase 3Phase 2Clinical ResultDrug ApprovalLicense out/in
Italian pharma Chiesi Farmaceutici has agreed to pay Gossamer Bio up to $486 million in milestones and other payments to jointly develop and commercialise seralutinib (GB002), the latter's experimental inhaled drug for pulmonary hypertension.
Upfront, Gossamer will receive $160 million from Chiesi as a development reimbursement payment. The biotech is also eligible for up to $146 million more if seralutinib hits regulatory milestones and $180 million tied to sales milestones.
The PDGFRα/β, CSF1R, and c-KIT inhibitorc-KIT inhibitor is designed to be delivered via dry powder inhaler. Gossamer has been developing the drug for pulmonary arterial hypertension (PAH), where a registrational Phase III trial called PROSERA is already underway. A top-line readout is expected in the fourth quarter of 2025, according to H. C. Wainwright analysts.
Expansion to PH-ILD
Under the deal, Gossamer and Chiesi now plan to launch a second Phase III trial of seralutinib in mid-2025 focused on pulmonary hypertension associated with interstitial lung disease (PH-ILD). Giuseppe Accogli, chief executive at Chiesi Group, said seralutinib could be a "paradigm shifting therapy" for both indications.
Data from the Phase II TORREY study, recently published in the Lancet Respiratory Medicine, showed a significant improvement with seralutinib compared to placebo on the primary endpoint of reduction in pulmonary vascular resistance (PVR) at 24 weeks, and other key measures such as right heart structure and function.
Under the agreed terms, Chiesi has exclusive rights to commercialise seralutinib outside the US and will pay Gossamer an "escalating mid-to-high teens royalty" on net sales in those territories. In the US, the companies will split commercial profits and losses evenly, with Gossamer leading commercialisation, including contributing 50% of commercial activities and booking of sales for both PAH and PH-ILD. Chiesi will lead US commercialisation for additional indications.
The deal comes shortly after Merck & Co. won an FDA approval for its drug Winrevair (sotatercept-csrk) in March, making it the first activin signaling inhibitor for PAH cleared in the US. For more, see Spotlight On: Winrevair approval could help Merck & Co. overcome its Keytruda issues.
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