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欧洲基因疗法先驱UniQure在美增设工厂

来源:生物谷 2013-08-03 18:03

2013年8月3日讯 /生物谷BIOON/ --欧洲基因疗法先驱UniQure公司日前宣布将在美国Lexington增设一处生产基因疗法产品的工厂以与其位于荷兰阿姆斯特丹的工厂互补并拓展其业务。这次计划,公司得到了投资公司多大1000万美元的投资。该处工厂将计划用于生产治疗腺病毒相关病毒基因疗法所需要的药物。

UniQure公司是第一个开发出获得通过了的基因疗法的公司。在2012年11月,公司开发的治疗脂蛋白脂酶缺乏症的基因疗法Glybera获得欧盟批准。虽然该疗法尚未获得FDA通过,但公司CEO表示公司计划于未来的12个月到18个月内使其获得FDA批准。(生物谷Bioon.com)

详细英文报道:

UniQure has scored capital and talent to build out 55,000 square feet of manufacturing space for production of gene therapies. The planned Lexington, MA, facility is expected to complement existing manufacturing capacity at its home base in Amsterdam.

The biotech company, which makes the first approved gene therapy in the West, has reeled in $10 million in venture debt from Hercules Technology Growth Capital to support construction at the Lexington site. Lance Weed, who previously oversaw Amgen's ($AMGN) construction of a drug-production facility in Woburn, MA, will start work on Sept. 1 as uniQure's vice president of U.S. operations.

UniQure's Lexington facility is expected to manufacture therapies that use adeno-associated virus (AAV) gene therapies, which deliver healthy genes into cells to treat diseases. In November 2012, the company won European Union approval for Glybera, a gene therapy for the extremely rare disease lipoprotein lipase deficiency (LPLD). The company does not have FDA approval of Glybera, but last month uniQure CEO J?rn Aldag said his company would clarify its plans for getting the therapy approved in the U.S. in the next 12 to 18 months.

The company aims to use the added manufacturing capacity to become a major player in gene therapy, and the Lexington facility would help establish the group as a go-to partner in the field, able to produce plenty of supplies for clinical trials and commercialization. In addition to gene therapy for LPLD, the biotech group wants to use the approach to develop treatments for hemophilia, hearing loss, Parkinson's disease and Sanfilippo syndrome.

"The construction of this facility represents our commitment to establishing a global, fully integrated gene therapy company as we continue to build on our leadership position in the field of AAV-based gene therapy products," Aldag said in a statement.

 

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