Bayer and Cytokinetics, Incorporated (Nasdaq: CYTK), a late-stage specialty cardiovascular biopharmaceutical company, today announced they have entered into a collaboration and license agreement for the exclusive development and commercialization of aficamten in Japan, subject to certain reserved development rights of Cytokinetics. Aficamten is a cardiac myosin inhibitor for the potential treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM).

拜耳和后期心血管专科生物制药公司 Cytokinetics, Incorporated (Nasdaq: CYTK) 今天宣布，双方已达成合作和许可协议，在日本独家开发和商业化阿菲卡汀，但须遵守 Cytokinetics 保留的某些开发权。阿菲卡汀是一种心脏肌球蛋白抑制剂，可用于治疗阻塞性和非阻塞性肥厚型心肌病 (HCM) 患者。

This collaboration agreement leverages Cytokinetics’ broad development program for aficamten and Bayer’s regional capabilities and expertise in the development and commercialization of specialty cardiology diseases of unmet need for the benefit of patients in Japan.

该合作协议利用 Cytokinetics 针对阿菲坎汀的广泛开发计划和拜耳在开发和商业化尚未满足需求的专科心脏病疾病方面的区域能力和专业知识，以造福日本患者。

Under the joint development plan, Bayer intends to conduct a Phase III clinical trial in Japanese patients with obstructive HCM and Cytokinetics will expand ACACIA-HCM, the ongoing global Phase III clinical trial of aficamten in patients with non-obstructive HCM, into Japan, to support the potential marketing authorization of aficamten in Japan for Bayer and CEDAR-HCM, its ongoing study for a pediatric population of patients with obstructive HCM.

根据联合开发计划，拜耳计划在日本阻塞性 HCM 患者中开展一项 III 期临床试验，而 Cytokinetics 将把正在进行的阿菲卡汀针对非阻塞性 HCM 患者的全球 III 期临床试验 ACACIA-HCM 扩展到日本，以支持拜耳在日本获得阿菲卡汀的潜在营销授权，以及支持其正在进行的针对阻塞性 HCM 儿科患者人群的研究 CEDAR-HCM。

Earlier this year, aficamten has received Breakthrough Therapy designations for the treatment of symptomatic obstructive HCM from the U.S. Food & Drug Administration (FDA) as well as the National Medical Products Administration (NMPA) in China.

今年早些时候，aficamten 获得了美国食品药品监督管理局 (FDA) 和中国国家药品监督管理局 (NMPA) 颁发的治疗症状性阻塞性 HCM 的突破性疗法认定。

“We are very excited by the potential of aficamten as seen in previous studies and look forward to bringing this treatment option to Japanese patients as soon as possible,” said Juergen Eckhardt, M.D., Head of Business Development and Licensing at Bayer’s Pharmaceuticals Division. “This collaboration underscores our mission to bring transformative treatments to patients with high unmet cardiovascular needs by leveraging our extensive drug development expertise from early discovery through regulatory approval, life cycle management and commercialization.”

拜耳制药部门业务开发和许可主管 Juergen Eckhardt 医学博士表示：“正如之前研究中所看到的，我们对阿菲卡汀的潜力感到非常兴奋，并期待尽快将这种治疗方案带给日本患者。”“此次合作凸显了我们的使命，即利用我们丰富的药物开发专业知识，从早期发现到监管审批、生命周期管理和商业化，为心血管需求未得到满足的患者提供变革性治疗。”

“As we pursue commercialization of aficamten in the U.S. and Europe, we are pleased to enter into this partnership with Bayer to leverage their cardiovascular commitment and expertise to potentially bring aficamten to an even greater number of patients suffering from HCM,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “This important regional deal follows on our rich history of collaborations to expand potential access to our innovative science.”

Cytokinetics 总裁兼首席执行官 Robert I. Blum 表示：“在我们寻求在美国和欧洲实现阿菲卡汀商业化的同时，我们很高兴与拜耳达成这一合作，利用拜耳对心血管的承诺和专业知识，将阿菲卡汀带给更多 HCM 患者。这项重要的区域协议延续了我们丰富的合作历史，旨在扩大我们创新科学的潜在应用范围。”

Under the terms of the agreement, Cytokinetics will receive an upfront payment of €50 million and is eligible to receive up to an additional €90 million upon the achievement of milestones through commercial launch, including €20 million which are near-term. Cytokinetics is also eligible to receive up to €490 million in commercial milestone payments upon the achievement by Bayer of certain sales milestones, and tiered royalties on net sales of aficamten in Japan.

根据协议条款，Cytokinetics 将获得 5000 万欧元的预付款，并有资格在通过商业发布实现里程碑后获得最多 9000 万欧元的额外付款，其中包括 2000 万欧元的近期付款。在拜耳实现某些销售里程碑后，Cytokinetics 还有资格获得最多 4.9 亿欧元的商业里程碑付款，以及日本 aficamten 净销售额的分级特许权使用费。