Acalabrutinib连获三罕见病适应症,阿斯利康40亿美元收购立马见效!

  • 阿斯利康,收购,股权
  • 生物谷

2016年3月8日讯去年12月阿斯利康花费巨资40亿美元收购私营药企Acerta Pharma BV55%股权,现在看来是非常明智的,因为其关键药acalabrutinib收获欧洲药监局授予孤儿药资格,其估计上市后销售峰值可达50亿美元!

Acalabrutinib在欧洲连连告捷,已经连续收获三个孤儿药适应症,分别针对慢性淋巴细胞白血病(CLL)/小淋巴细胞淋巴瘤(SLL)、套细胞淋巴瘤(MCL)和淋巴浆细胞性淋巴瘤。孤儿药是被授予治疗罕见疾病的药物,在欧洲罕见病的定义是不足万分之五的人群患病。

阿斯利康医药总裁Sean Bohen称,欧洲药监局授予acalabrutinib三个个孤儿药适应症充分体现了公司合并Acerta的“长远战略”眼光。公司在治疗各种血癌方面已有清晰的战略,那就是开发一流的药品。

Acalabrutinib是第二代布鲁顿氏酪氨酸激酶(BTK)抑制剂,该药物可以通过永久性结合BTK来发挥作用,BTK是一种特殊蛋白的一部分,而这种特殊蛋白可以从CLL细胞表面将信号传递细胞核中的基因,从而促进癌细胞生存和生长,通过阻断BTK,药物acalabrutinib就可以抑制CLL细胞的生长信号,直至促进癌细胞死亡。

Acalabrutinib的早期临床数据结果也令人欣喜。最近发表在新英格兰医学杂志上的I/II期临床试验结果显示,慢性淋巴细胞白血病患者用药应答率达到了95%,而慢性淋巴细胞白血病是成人白血病中最为常见的一种。

其良好的临床效果使其有望成为治疗CLL的重磅药,并和由艾伯维公司和罗氏公司联合开发的Venetoclax进行有力竞争。该药物是一种实验性B细胞淋巴瘤因子-2(BCL-2)抑制剂。BCL-2是一种可阻止一些细胞(包括淋巴细胞)凋亡的蛋白,该因子在发生于淋巴结、批准和免疫系统其他器官中的癌细胞高度表达。venetoclax旨在选择性抑制BCL-2因子的功能,恢复细胞的通讯系统,让癌细胞自我毁灭,以达到治疗肿瘤的效果。

如果Acerta Pharma的抗癌药物得到了美国和欧洲监管当局的批准,那么阿斯利康可以行使其30亿美元购买Acerta Pharma剩余45%股权的权利。

为实现2023年年销售额450亿美元目标,阿斯利康正在寻求重磅药物。通过企业兼并与收购获得新药可以帮助公司跨过专利悬崖和仿制药竞争的泥潭。阿斯利康面临重磅胃药埃索美拉唑Nexium和降脂药物瑞舒伐他汀钙Crestor的专利悬崖,但是同时公司治疗非小细胞肺癌药Tagrisso也于去年12月获批上市,而Acalabrutinib也将成为补强其新药管线的一员猛将。

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