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III期试验成功—Medicines耗资$2.4亿收购ProFibrix

来源:生物谷 2013-08-06 08:05

2013年8月6日讯 /生物谷BIOON/ --Medicines公司今天公布了生物制剂Fibrocaps的关键性III期临床试验FINISH-3的数据,该项试验在美国和西欧的65个站点开展,涉及719例患者,在4个不同的手术适应症脊柱外科、肝切除、软组织剥离、血管手术中,均达到了所有主要和次要止血疗效终点。

Fibrocaps是荷兰生物技术公司ProFibrix开发的一种生物制剂,这是一种干粉外用配方的纤维蛋白原和凝血酶,开发用于手术过程中,帮助止血。

公布FINISH-3试验数据的同时,Medicines宣布,支付9000万美元收购ProFibrix公司的所有资产,Fibrocaps获EMA及FDA监管批准后,还将支付高达1.4亿美元的监管里程碑和销售里程碑款项。今年6月,Medicines已支付1000万美元的选择权付款,根据FINISH-3试验的数据,是否收购ProFibrix公司。

ProFibrix也开发了一款互补的干粉喷雾给药装置,来帮助外科医生准确地应用Fibrocaps。最近ProFibrix开发的无菌生物止血交付系统及其配件的设计、开发、制造、控制质量管理体系获得了ISO 14385:2003认证。欧洲CE认证申请及FDA 510k审查正在进行中。

Medicines计划于2013年第四季度向欧洲药品管理局(EMA)提交Fibrocaps的上市许可申请(MAA),2014年第一季度向FDA提交Fibrocaps的生物制品许可申请(BLA)。

Medicines公司相信,若获得批准,Fibrocaps在主要市场的年销售额将超过3亿美元。(生物谷Bioon.com)

英文原文:Medicines Co. wraps $240M deal to buy ProFibrix following PhIII success

The Medicines Company has swooped in to buy out the Dutch biotech ProFibrix, chipping in $90 million in cash on top of a $10 million option anted up in June as Phase III data on a lead surgical therapy loomed. And the buyer has agreed to pay up to $140 million more for a set of unspecified milestones.

The Medicines Company ($MDCO) is landing Fibrocaps in the deal, an easy-to-use dry-powder formulation of fibrinogen and thrombin that can be used to stop bleeding during surgery, a process referred to as hemostasis. In their release today the companies noted that the lead biologic hit all primary and secondary endpoints on four surgical indications: spinal surgery, hepatic resection, soft tissue dissection and vascular surgery. Investigators recruited 719 patients for the Phase III study.

The plan now is to file for EU approval in the fourth quarter of this year, with an FDA application following in the first quarter of 2014, ProFibrix CEO Jan Ohrstrom tells FierceBiotech. And The Medicines Company believes it can earn more than $300 million a year on the product, provided it wins key approvals.

"The company was founded in 2007 with an A round from Index Ventures," adds Ohrstrom. Phase I was run in 2008 and investigators are now wrapping a 5-year clinical program, with more work scheduled on laparoscopic surgery as well as a pediatric program. The CEO says more indications are also being "toyed with," but he declined to elaborate. The company's lab in Leiden will stay operational, says Ohrstrom, the former chief medical officer of ZymoGenetics. ProFibrix currently has 25 employees in Leiden and Seattle, where it has a clinical development site.

"Subject to regulatory approval, we believe Fibrocaps can become an important hemostatic product--complementary to Recothrom (Thrombin, topical [Recombinant])," says Clive Meanwell, the CEO at The Medicines Co. "We anticipate leverage of our work with U.S. surgery centers and entry into the European market. … ProFibrix also has a proprietary recombinant fibrinogen development program which potentially allows us to create the world's first recombinant thrombin and recombinant fibrinogen combination products. We plan to integrate the ProFibrix team with our existing Recothrom team--expanding our activities in surgery in pursuit of our purpose which is to save lives, alleviate suffering and improve the economic efficiency of leading hospitals worldwide."

The market for hemostatic products has been busy with new developments for years. Just a few weeks ago Omrix Biopharmaceuticals won a recommendation from the CHMP in Europe for the sealant matrix Evarrest, which also combines fibrinogen and thrombin. But The Medicines Company is hoping that ProFibrix's off-the-shelf technology will quickly win converts.

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