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Array BioPharma从诺华手中收回肿瘤药binimetinib授权

2014-12-08 13:29:17 来源:生物谷

2014年12月6日讯/生物谷BIOON/--Array BioPharma与诺华制药签订新协议,希望收回binimetinib(一种MEK抑制剂)三期临床试验的全球权益。

2010年,诺华获得了binimetinib的专属授权,在研发和商业化方面独享权益。

Binimetinib是专门针对癌症病人的激酶抑制剂,目前正在三期临床研发过程中,Array希望在2016年年初向监管部门提交审议议案。

在最新签订的协议中,Array有权从诺华得到8500万美元,并且诺华还会提供过渡监管、临床研发和制造方面的服务。此外,诺华还将为Array提供专利权和其它与binimetinib有关的财产权益。

Array的CEO Ron Squarer声称,收回binimetinib这一新型晚期抗癌药的全球权益,对Array而言是一个巨大的商业机会。此外,签订此项协议之后,Array在研发和销售方面就占据了强有力的优势地位。

然而,binimetinib的临床试验不受此项协议的影响,依然会照常进行。

在签署协议之后30个月,诺华依然持有所有临床和商业领域的binimetinib供应权。此次交易是在葛兰素史克收购诺华肿瘤部分之后发生的。

原文 Array BioPharma to regain global rights for binimetinib cancer drugfrom Novartis

Array BioPharma has signed a deal with Novartis International Pharmaceutical to regain worldwide rights for binimetinib, a MEK inhibitor in three Phase 3 trials.

Novartis had been granted exclusive license in 2010, to develop and commercialize binimetinib.

Designed specifically for cancer patients, the binimetinib is currently advancing in three Phase 3 clinical trials. Array intends to submit a proposal to regulatory authorities in the early 2016.

Under the latest deal, Array is entitled to receive around $85m and Novartis will provide transitional regulatory, clinical development and manufacturing services.

Novartis will also issue Array with patent and other property rights associated with the binimetinib.

Array BioPharma CEO Ron Squarer said: "Regaining full worldwide rights to binimetinib, an innovative late-stage oncology product, represents a tremendous opportunity for Array."

"With this agreement, we are in a strong position to successfully develop and commercialize binimetinib to the benefit of cancer patients," Squarer added.

Clinical trials, including the COLUMBUS, NEMO and MILO, involving binimetinib will have no impact with the arrangement and will continue as usual.

On Completion of the deal, Novartis will retain binimetinib supply for all clinical and commercial segments for around 30 months.

The transaction is subject to the completion of Novartis acquisition of oncology unit of Britain's GlaxoSmithKline (GSK).

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