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首页 » 阿斯利康 » 欧盟医药管理部门将表决是否加速阿斯利康卵巢癌药物olaparib审批流程

欧盟医药管理部门将表决是否加速阿斯利康卵巢癌药物olaparib审批流程

来源:生物谷 2014-10-15 12:57

2014年10月15日/生物谷BIOON/ --阿斯利康公司最近透露,鉴于公司开发的治疗卵巢癌药物olaparib的研究取得积极进展,欧洲医药管理部门的专家们已经同意于下周开始正式审核公司开发的这种抗癌药物并表决是否允许加速其审批过程。有分析人士预计这一药物一旦上市,其年最大销售额将可能达到20亿美元左右。如果这一审核获得通过,无疑是为olaparib的上市扫清了又一大障碍。不过此前在今年的六月份,美国管理部门的专家投票拒绝加速这一药物的研究。

olaparib是通过阻断癌细胞中一种相关细胞修复的酶来达到治疗特定基因突变型癌症患者的效果,目前,阿斯利康的研究人员也正在研究这种药物在联合治疗中所起的作用。而近年来,多种药物联合治疗方案已经隐隐上升为癌症治疗中的热门选择

今年五月以来,阿斯利康公司一直置身于辉瑞收购案的漩涡当中,为了避免被收购,阿斯利康公司不得不更加重视起研发项目的进行以提振投资人信心。同时,阿斯利康公司也顺势将研发部门的工作重心转移到癌症药物的研发上面。公司同时表示,到2023年癌症药物的销售将占据公司营业总额的75%之多。

而最近,阿斯利康公司的研发项目也是喜忧参半,一方面是公司终止了与Targacept公司在神经领域长达九年的合作,以失败告终(相关阅读:苦求9载无果,阿斯利康最终终止与Targacept合作);另一方面是公司开发的哮喘病药物benralizumab研究取得良好进展(相关阅读:阿斯利康呼吸类药物benralizumab治疗哮喘研究取得进展)。(生物谷Bioon.com)

详细英文报道:

AstraZeneca's cancer drug pipeline, already on a roll following promising clinical trial results, could get a further boost next week from a European green light for an experimental medicine against ovarian cancer.

European Medicines Agency experts will consider whether to recommend approval of olaparib at their regular monthly meeting, with a decision expected on Oct. 23 or 24, a company spokeswoman said.

A positive decision would be a fillip for a product that AstraZeneca has flagged as a potential $2 billion-a-year seller but which hit a road bump in June when a U.S. panel voted against its accelerated approval.

Olaparib blocks an enzyme involved in cell repair and is designed for patients with certain hereditary gene mutations. It also has promise in treating breast and gastric cancers, opening up a substantial market opportunity.

In addition, it is being tested in combination therapy, an approach widely seen as the future of cancer treatment because of the need to fight tumor cells on several fronts.

Cancer medicine is central to AstraZeneca's claims that it has a strong independent future, after fending off a $118 billion takeover bid from Pfizer in May.

As part of its defense, the British drugmaker set out a bullish set of forecasts for its drug pipeline and predicted that group sales would climb 75 percent by 2023.

While still seen as ambitious, that upbeat assessment is beginning to win over more analysts as the company makes good progress in its drug development programs.

Bank of America Merrill Lynch was the latest to trumpet AstraZeneca's drug pipeline on Tuesday, following a glowing report on its cancer medicines from Jefferies a day earlier.

Most interest is focused on the company's rapidly developing line-up of experimental immunotherapy treatments, which boost the immune system's ability to fight cancer. Research presented at a cancer congress in Madrid last month suggests AstraZeneca is in a strong position in this field.

Bank of America analysts said the drugmaker's "dramatic pipeline progression" had prompted them to increase peak risk-adjusted sales forecasts by $16 billion in the past 12 months.

A recent move by the U.S. Treasury to curb "inversion" deals that allow firms to escape high U.S. taxes by reincorporating abroad has recently deflated expectations of a renewed Pfizer bid and Bank of America sees only a "low probability" of a deal.

Jefferies, however, believes AstraZeneca remains one of the more viable inversion targets that Pfizer could contemplate.

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