Italian pharma Chiesi Group announced Monday that it has signed a potential $486 million global collaboration and licensing deal with Gossamer Bio to develop the pulmonary arterial hypertension treatment seralutinib.

意大利制药公司Chiesi集团周一宣布，它已与Gossamer Bio签署了一项潜在的4.86亿美元的全球合作和许可协议，以开发肺动脉高压治疗药物seralutinib。

Under the deal, Gossamer will lead the global development of seralutinib in pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The drug is a PDGFRα/β, CSF1R, and c-KIT inhibitor that delivers a dry powder via an inhaler.

根据该协议，Gossamer将领导seralutinib在肺动脉高压（PAH）和与间质性肺病（PH-ILD）相关的肺动脉高压中的全球开发。该药物是PDGFRα/β，CSF1R和c-KIT抑制剂，可通过吸入器输送干粉。

San Diego-based biotech Gossamer will receive $160 million in development reimbursement and is eligible to receive up to $146 million in regulatory and $180 million in sales milestones. The biotech will also take the lead on commercialization and booking sales for the drug in PAH and PH-ILD in the U.S., with both companies providing 50% of the commercial efforts. .

总部位于圣地亚哥的biotech Gossamer将获得1.6亿美元的开发报销，并有资格获得高达1.46亿美元的监管费用和1.8亿美元的销售里程碑费用。该生物技术公司还将率先在美国的PAH和PH-ILD中进行药物的商业化和预订销售，两家公司都提供了50%的商业努力。。

Chiesi will lead the drug’s commercialization in the U.S. for other indications and get the exclusive rights to seralutinib outside of the U.S. The pharma will pay Gossamer an “escalating mid-to-high teens” royalty on net sales as well. Chiesi and Gossamer will split the development costs for the drug except the biotech is financially responsible for a Phase III trial of seralutinib in patients with PAH.

Chiesi将领导该药物在美国的其他适应症商业化，并获得seralutinib在美国境外的独家使用权。该制药公司还将向Gossamer支付净销售额“不断上升的中高青少年”版税。Chiesi和Gossamer将分摊该药物的开发成本，但生物技术公司在财务上负责对PAH患者进行seralutinib的III期试验。

The companies plan to initiate a global Phase III registrational study in PH-ILD in mid-2025..

这些公司计划在2025年年中启动PH-ILD全球第三阶段注册研究。。

“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,” Gossamer CEO Faheem Hasnain said in a statement. “We are particularly thrilled that this collaboration enables seralutinib to move directly into a Phase III trial in PH-ILD, an indication with a paucity of available treatments, and a disease which we believe seralutinib is specifically designed to address.”.

Gossamer首席执行官Faheem Hasnain在一份声明中表示：“与Chiesi的这种合作关系使我们能够有意义地深化并迅速加速我们对seralutinib的投资，作为PAH，PH-ILD和其他未满足医疗需求的潜在治疗方法。”。“我们特别高兴的是，这项合作使seralutinib能够直接进入PH-ILD的III期临床试验，这是一种缺乏可用治疗的迹象，我们认为seralutinib是专门针对这种疾病设计的。”。

Gossamer started seralutinib’s Phase III PAH trial last year after reaching its primary endpoint in a Phase II study in 2022. The Phase II study’s primary endpoint was a change from baseline to week 24 in pulmonary vascular resistance, a primary cause of pulmonary hypertension. However, the study did not reach the secondary endpoint of a six-minute walk distance, and both endpoints failed to meet statistical significance..

Gossamer在2022年的一项II期研究中达到其主要终点后，去年开始了seralutinib的III期PAH试验。II期研究的主要终点是肺血管阻力从基线到第24周的变化，肺血管阻力是肺动脉高压的主要原因。然而，这项研究没有达到六分钟步行距离的次要终点，两个终点都没有达到统计学意义。。

The six-minute walk distance is also a major point of investigation in the Phase III study. Nevertheless, Chiesi and Gossamer remain bullish about patients’ response to the drug and are optimistic about future development.

六分钟步行距离也是第三阶段研究的主要调查点。尽管如此，Chiesi和Gossamer仍然看好患者对该药物的反应，并对未来的发展持乐观态度。

“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 world-wide,” Chiesi Group CEO Giuseppe Accogli said in a statement.

Chiesi集团首席执行官Giuseppe Accogli在一份声明中表示：“Seralutinib是PAH和PH-ILD潜在的范式转换疗法，我们非常高兴能与Gossamer合作开发这种疗法并将其应用于全球患者。”。

Seralutinib’s development comes on the heels of Merck winning approval for Winrevair, the first FDA-approved activin signaling inhibitor for PAH, in March 2024. The drug targets an underlying cause of the disease. Merck gained access to Winrevair after acquiring Acceleron Pharma for $11.5 billion in 2021. .

Seralutinib的开发紧随默克公司于2024年3月获得Winrevair的批准，Winrevair是FDA批准的第一种用于PAH的激活素信号抑制剂。这种药物针对的是这种疾病的根本原因。在2021年以115亿美元收购Acceleron Pharma后，默克获得了Winrevair。