Amgen gets block on sales of Repatha rival in Germany

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.