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默克公司新推出的Keytruda注射剂在欧洲遭法院裁决阻挠Merck’s New Keytruda Shot Blocked in Europe After Court Loss

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默克公司位于新泽西州拉威的总部。摄影师:Christopher Occhicone/BloombergMerck headquarters in Rahway, New Jersey. Photographer: Christopher Occhicone/Bloomberg

止在多个欧洲国家销售其重磅抗癌药物可瑞达的新型皮下注射剂型,这一举措对这家制药商在专利即将到期之际努力拓展核心产品线的计划构成了阻碍。

Merck & Co. was blocked from selling a new injectable version of its blockbuster cancer drug Keytruda in several European countries, dealing a setback to the drugmaker’s efforts to extend its most important franchise ahead of looming patent expirations.

根据药物递送技术公司Halozyme Therapeutics Inc.发布的声明,一家荷兰法院裁定:默克的欧洲子公司须停止在比利时、丹麦、法国、爱尔兰、意大利、荷兰、瑞典及瑞士生产、销售或储存可瑞达的皮下注射剂型。目前Halozyme正就多项专利纠纷对默克提起诉讼。

A Dutch court ordered Merck’s European unit to stop manufacturing, selling or stocking the subcutaneous version of Keytruda in Belgium, Denmark, France, Ireland, Italy, the Netherlands, Sweden and Switzerland, according to a statement from drug delivery company Halozyme Therapeutics Inc., which has several suits underway against Merck.

Halozyme于周三透露,法院认定该产品侵犯了其持有的某项涉及皮下给药技术的专利。

The court found that the product infringed one of Halozyme’s patents covering technology used to deliver medicines under the skin, Halozyme said Wednesday.

周三纽约股市开盘时,默克股价变动不大。该公司暂未对置评请求作出回应。Halozyme的股价则上涨了2.1%。

Merck’s shares were little changed when markets opened in New York on Wednesday. The company didn’t immediately respond to a request for comment. Halozyme’s shares rose 2.1%.

随着可瑞达的核心专利将于本世纪20年代陆续到期,这一裁决令默克保护这款全球最畅销抗癌药物的战略面临更多变数。默克研发该皮下注射剂型(在美国以“可瑞达Qlex”为名销售),部分目的正是为了在价格更低的仿制药涌入市场前引导患者改用新剂型。

The ruling complicates Merck’s strategy for protecting Keytruda, the world’s top-selling cancer medicine, as its core patents begin expiring later this decade. Merck has developed the under-the-skin formulation, sold as Keytruda Qlex in the US, in part to shift patients away from the original intravenous version before cheaper copies arrive.

上个季度,可瑞达Qlex为默克贡献了4.63亿美元的营收,预计其未来有望成为一款年销售额达数十亿美元的重磅药物。

Merck reported $463 million in sales from Keytruda Qlex last quarter. It’s expected to become a multibillion dollar product.

相较于原静脉注射剂型所需的约30分钟输液时间,新剂型仅需几分钟即可完成注射,极大提升了患者与医生的使用便利性。默克预计,最终将有相当比例的符合条件的可瑞达患者转而使用新剂型。

The new injectable version can be administered in minutes, compared to about 30 minutes for the intravenous infusion, making it more convenient for patients and doctors. Merck has said it expects a significant portion of eligible Keytruda patients to eventually switch to the new formulation.

然而,这项技术也引发了默克与Halozyme之间的全球专利纠纷。后者专门向制药企业提供药物递送技术许可,并坚称默克的生产方式侵犯了自身的知识产权。目前Halozyme亦已在美国对默克提起诉讼。

However, the technology has put Merck into a global patent fight with Halozyme, which licenses its own drug-delivery technology to pharmaceutical companies and contends Merck’s approach infringes its intellectual property. Halozyme has also sued Merck in the US.

欧洲的这一决定并未影响原版静脉注射用Keytruda的销售。不过,对这种较新配方的限制可能会增加默沙东引导患者转用注射剂的难度。默沙东还在美国和其他地区对Halozyme的专利提出了异议。

The European decision doesn’t affect sales of the original intravenous Keytruda. Still, restrictions on the newer formulation could complicate Merck’s effort to move patients to the shot. Merck has also filed challenges to Halozyme’s patents in the US and elsewhere.