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Baxter血液病新药BAX111三期临床研究成功

来源:生物谷 2014-04-18 08:54

2014年4月17日讯 /生物谷BIOON/ --Baxter公司最近宣布公司在血液病药物研发领域再下一城,公司开发的BAX111在治疗一种罕见出血紊乱--血管性血友病的临床三期研究中完成了实验预期目标。根据Baxter公司的数据显示在治疗血管性血友病过程中受试志愿者对这种药物的反应率达到了100%。Baxter公司表示将在今年晚些时候披露该研究所有细节并希望在今年底完成向FDA的申请并获得孤儿病药物认证。与此同时,公司还计划着手开始研究BAX111作为预防出血药物的可能性。如果BAX111能够获得FDA的批准,它将成为Baxter公司血液病药物组合中另一种重要成员。

目前Baxter公司还在想FDA申请开始一种血液药物BAX855的临床三期研究。

虽然Baxter公司目前以血液病药物著名,不过近年来这家生物制药公司仍然开始涉足另外的领域,如与Onconova等公司开发抗癌药物等。(生物谷Bioon.com)

详细英文报道:

Baxter ($BAX) charted another late-stage success in its growing hemophilia franchise, posting positive top-line results for an orphan bleeding disorder treatment.

In a Phase III trial, Baxter's investigative BAX 111 met its primary efficacy endpoint of treating bleeding episodes in patients with von Willebrand disease, an inherited bleeding disorder. The drug is a recombinant version of the von Willebrand coagulation factor, which is either insufficient or defective in patients with the eponymous disease. The trial tested 111 both as a stand-alone therapy and in tandem with Baxter's hemophilia-treating Advate, finding that the drug worked on demand in 100% of patients who experienced bleeds during the study. The company intends to reveal the full results at a medical congress later this year.

Baxter expects to file for FDA approval for the orphan drug by the end of 2014, and the company plans to kick off a study to determine whether 111 can reduce bleeding rates when used as a prophylaxis.

If 111 wins the agency's blessing, it'll join Baxter's multibillion-dollar bleeding franchise led by the treatments Advate and Feiba. The company is planning to file an FDA application for the Phase III factor VIII treatment BAX 855 this year, and Baxter is working through Phase III for a factor VIIa treatment and Phase I for a hemophilia gene therapy, pipeline drugs the company believes present a roughly $2 billion global opportunity.

Meanwhile, Baxter is preparing to split its sprawling med tech operation from its hemophilia-focused pharma business. By mid-2015, the company expects to consolidate its dialysis-dominant device segment under the old company name and spin out its drug business under an as-yet-undisclosed moniker, installing bioscience boss Ludwig Hantson as CEO of the planned $6 billion new company.

Baxter's biopharma future isn't entirely hemophilia-dependent. The company has expanded into hematology and oncology through partnerships with Onconova ($ONTX) and Cell Therapeutics ($CTIC), and Baxter has its eye on biosimilars, teaming up with Coherus BioSciences to develop a copy of Amgen ($AMGN) and Pfizer's ($PFE) blockbuster Enbrel with plans to file for FDA approval in 2016.

 

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