Court bans US sales of Sanofi cholesterol drug

2017 could not have started worse for Sanofi – already under pressure due to falling insulin sales, a court has banned it from selling its cholesterol drug Praluent in the US, after finding it infringes patents held by rival Amgen.

The US District Court in Delaware granted a request for a permanent injunction prohibiting Sanofi and Regeneron from manufacturing, using, selling or offering Praluent (alirocumab) for sale in the US.

Sanofi and Regeneron have said they are to appeal, and will be able to sell Praluent for another four weeks or so, during which time they are allowed to file a motion for a suspension of the injunction.

The judge’s decision follows a jury verdict, which went against Sanofi, in March last year, in a trial on the validity of two patents protecting Amgen’s rival Repatha (evolocumab), which like Praluent is a PCSK9 inhibitor.

Sanofi got Praluent approved in the US in July 2015 for familial heterozygous hypercholesterolaemia, or patients with atherosclerotic heart disease requiring additional lowering of LDL-cholesterol.

The FDA approved Repatha a month later for the same uses, plus homozygous familial hypercholesterolaemia, and the two drugs have been duking it out on the market ever since.

Both companies are also conducting additional trials to see whether the drugs reduce cardiovascular events in high-risk patients.

Sales of both have been disappointing, falling short of investors’ expectations, as payers have been put off by the high price of both medicines.

Amgen said it can supply all potential Repatha patients and will work to ensure a smooth transition for patients who wish to switch.

Amgen’s CEO, Robert Bradway, said: “Sanofi and Regeneron admitted that they had infringed our patents, and the jury upheld our patents as valid. Protecting intellectual property is essential to our industry as it reinforces the incentives for the large and risky investments we make in innovation to bring forward new medicines to treat serious diseases.”

But Sanofi’s executive vice president and general counsel, Karen Linehan, said: “It is our longstanding position that Amgen's patent claims are invalid and that the best interests of patients will be greatly disserved by an injunction preventing access to Praluent."