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武田和Protagonist Therapeutics宣布达成先进罕见血液学资产Rusfertide的全球许可与合作协议

Takeda and Protagonist Therapeutics Announce Global License and Collaboration Agreement for Rusfertide, an Advanced Rare Hematology Asset

PHARMA FOCUS ASIA 等信源发布 2024-02-01 14:58

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Takeda (TSE:4502/NYSE:TAK) and Protagonist Therapeutics, Inc., (Nasdaq: PTGX) have inked a global license and collaboration agreement for the development and commercialization of rusfertide, an investigational injectable hepcidin mimetic peptide designed to mimic the natural hormone hepcidin. Rusfertide is currently undergoing a pivotal Phase 3 trial, VERIFY, for the treatment of Polycythemia Vera (PV), a rare chronic blood disorder characterized by the overproduction of red blood cells, affecting approximately 160,000 patients in the U.S.

武田(东京证交所:4502/纽约证交所:TAK)和Protation Therapeutics,Inc.(纳斯达克:PTGX)已经签署了一项全球许可和合作协议,用于开发和商业化rusfertide,一种旨在模拟天然激素hepcidin的研究性可注射hepcidin模拟肽。Rusfertide目前正在进行一项关键的3期临床试验,用于治疗真性红细胞增多症(PV),这是一种罕见的慢性血液病,其特征是红细胞过量产生,影响美国约160000名患者。

and a similar number in Europe.As per the agreement's terms, Protagonist will receive an upfront payment of $300 million, along with potential additional payments linked to global development and regulatory milestones, as well as commercial milestones and royalties on ex-U.S. net sales. Protagonist will continue to handle research and development until the completion of the Phase 3 clinical trial and U.S.

在欧洲也有类似的数字。根据该协议的条款,主角将获得3亿美元的预付款,以及与全球发展和监管里程碑相关的潜在额外付款,以及前美国的商业里程碑和版税。S、 净销售额。PROTAGITOR将继续进行研究和开发,直到3期临床试验和美国。

regulatory approval. Takeda will take charge of ex-U.S. development and lead global commercialization efforts.Protagonist Therapeutics, expressed the company's belief in finding the right partner at the right time to maximize the impact of their innovation. The deal allows Protagonist to focus on completing Phase 3 while leveraging Takeda’s global commercialization capabilities.

监管批准。武田将负责ex-U。S、 发展并领导全球商业化努力。Protation Therapeutics表示,公司相信在正确的时间找到正确的合作伙伴,以最大程度地发挥创新的影响。该协议允许主角专注于完成第三阶段,同时利用武田的全球商业化能力。

Patel highlighted the strategic advantages of mitigating execution risks during the first-time commercial launch, optimizing timing, and enhancing the potential sales scope for rusfertide. Protagonist will maintain a 50:50 profit split in the U.S. market, allowing active participation in the commercial experience and economics.Takeda's U.S.

Patel强调了在首次商业发布期间降低执行风险、优化时间安排和扩大rusfertide潜在销售范围的战略优势。主角将在美国市场维持50:50的利润分配,允许积极参与商业体验和经济活动。武田的美国。

Business Unit, emphasized the strategic move as part of Takeda's rare disease strategy. Takeda aims to leverage its infr.

该业务部门强调这一战略举措是武田罕见病战略的一部分。武田的目标是利用其infr。