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     121  0 Kommentare Gossamer Bio and Chiesi Group Announce Transformative Global Collaboration to Develop and Commercialize Seralutinib in PAH, PH-ILD & Other Indications - Seite 2

    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 need.

    Under the terms of the agreement, Gossamer will continue to lead global development of seralutinib in PAH and PH-ILD, and 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 commercialization and book sales for PAH and PH-ILD in the US, with both companies contributing 50 percent of commercial efforts. Chiesi will lead US commercialization in additional indications. Chiesi will have the exclusive right to commercialize seralutinib outside of the US and will pay Gossamer an escalating mid-to-high teens royalty on net sales. Chiesi will pay Gossamer $160 million as a development reimbursement. Additionally, Gossamer will be eligible to receive up to $146 million in regulatory milestones and $180 million in sales milestones.

    Conference Call and Webcast

    Gossamer’s management team will host a conference call and live audio webcast to discuss the partnership today, May 6th, at 8:30 a.m. EDT.

    The live audio webcast may be accessed through the “Events / Presentations” page in the “Investors” section of the Company’s website at www.gossamerbio.com. Alternatively, the conference call may be accessed through the following:

    Date / Time: May 6, 8:30am EDT
    Domestic Dial-in Number: 1-800-285-6670
    Conference Reference: Gossamer Bio Announcement Presentation
    Live Webcast: https://edge.media-server.com/mmc/p/5y35ojfx

    A replay of the audio webcast will be available for 30 days on the “Investors” section of the Company’s website, www.gossamerbio.com.

    About Gossamer Bio

    Gossamer Bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary hypertension. Its goal is to be an industry leader in, and to enhance the lives of patients living with, pulmonary hypertension.

    About Chiesi Group

    Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment.

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    Gossamer Bio and Chiesi Group Announce Transformative Global Collaboration to Develop and Commercialize Seralutinib in PAH, PH-ILD & Other Indications - Seite 2 Gossamer Bio, Inc. (“Gossamer”) (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary hypertension, and Chiesi Farmaceutici S.p.A (“Chiesi Group”), …