Amgen gets block on sales of Repatha rival in Germany
Part of ongoing battle with Sanofi and Regeneron
Amgen has chalked up a win in its legal disputes with Sanofi and Regeneron over their cholesterol-lowering drugs, winning a sales injunction in Germany.
The Dusseldorf Regional Court found that Sanofi and Regeneron’s Praluent (alirocumab) infringed a European patent (No. 2,215,124) that covers Amgen’s rival drug Repatha (evolocumab), and promptly agreed to a block on the manufacture, sale and marketing of Praluent in Germany.
For the injunction to go into effect, Amgen must enforce it by posting a bond, according to Sanofi, which said for now Praluent remains on the market and that the judgment doesn’t affect any other European markets.
The company added it was disappointed with the decision and “continues to believe that patients and physicians should have a choice of cholesterol-lowering therapies in order to achieve optimal lipid-lowering for patients.”
The lawsuit over the intellectual property for the PCSK9 inhibitor drugs dates back to 2016 when Amgen filed its patent infringement complaint shortly after Repatha was approved for marketing. Praluent was the first of the two drugs to be approved in Europe.
It’s first blood to Amgen in the European patent battle, and Repatha’s developer also seems to be out in front in US litigation as well. It won an injunction against Repatha sales in the US in 2017, which was overturned by an appeals court later that year, but Sanofi and Regeneron have also negotiated with Amgen with a view agreeing a license deal to settle the disputes, but that effort was abandoned without a deal.
They also attempted to persuade the German authorities to issue a compulsory licence for Praluent, but that failed too.
Both antibody drugs are designed to be used in patients who struggle to control their cholesterol levels using statin drugs, or who have inherited disorders that cause elevated cholesterol.
They were also both tipped as having blockbuster potential when they were first launched. Since then however sales have struggled to grow, largely due to resistance by payers to the new costly drugs at a time when the statins market has become generic and commoditised.
Their developers have had to reduce prices dramatically to try to gain some traction, and are hoping that new clinical data showing they can improve cardiovascular outcomes will help build momentum.
Repatha posted sales of $141m in the first quarter of 2019, with Praluent trailing on $64m for the three-month period.
安进公司在与赛诺菲公司和 Regeneron 公司的降胆固醇药物的法律纠纷中取得了胜利，在德国赢得了销售禁令。杜塞尔多夫地区法院裁定赛诺菲和 Regeneron 的 Praluent (alirocumab) 侵犯了一项欧洲专利（2215124），涵盖了安进的竞争对手药物 Repatha (evolocumab)，并迅速同意对 Praluent 在德国的生产、销售和上市进行封锁。据赛诺菲称，为了使禁令生效，安进必须通过发行债券来执行禁令。赛诺菲表示，目前 Praluent 仍在市场上销售，判决并不影响任何其他欧洲市场。该公司补充说，它对这一决定感到失望，并且“继续认为患者和医生应该有一种降胆固醇疗法的选择，以便为患者达到最佳降脂效果。" 关于 PCSK9 抑制剂药物知识产权的诉讼可追溯到 2016 年，当时安进在 Repatha 获批上市后不久就提起了专利侵权诉讼。Praluent 是这两个药物中第一个在欧洲获批的。这是安进公司在欧洲专利争夺战中的第一把血，Repatha 的开发商似乎也在美国诉讼中走在了前列。它在 2017 年赢得了针对 Repatha 在美国销售的禁令，同年晚些时候被上诉法院推翻，但赛诺菲和 Regeneron 也与安进进行了谈判，以期就解决争端达成授权交易，但这一努力没有达成协议就被放弃了。他们还试图说服德国当局颁发 Praluent 的强制许可，但也失败了。这两种抗体药物被设计用于使用他汀类药物难以控制其胆固醇水平的患者，或者患有遗传性疾病导致胆固醇升高的患者。它们在首次上市时也被认为具有巨大潜力。然而，自那以后，销售额一直难以增长，这主要是由于在他汀类药物市场变得仿制和商品化之际，支付者对新的昂贵药物的抵制。他们的研发人员不得不大幅降价，以试图获得一些吸引力，并希望新的临床数据显示，他们可以改善心血管结局将有助于建立势头。Repatha 在 2019 年第一季度的销售额为 1.41 亿美元，Praluent 三个月的销售额落后于 6400 万美元。
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