A U.S. federal judge handed Sanofi and partner Regeneron a stunning loss with a ban on sales of their cholesterol-lowering drug Praluent in the U.S. after a jury said it infringed Amgen’s patent for rival drug Repatha. But the judge left them some wiggle room with 30 days to appeal, and appeal they will, the partners said today.
In a release Friday, Sanofi said it and Regeneron proclaimed their intent and made clear Praluent will remain on the market in the U.S. when the battle royale continues. Analysts also said the injunction might be staid longer during the appeal.
"We will immediately appeal today's ruling, along with the jury's earlier finding upholding the validity of Amgen's patents," Sanofi General Counsel Karen Linehan said in the statement. "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."
The injunction was not entirely a surprise, because Judge Sue Robinson had threatened to block Praluent sales unless the parties struck a royalty agreement after a Delaware jury in March sided with Amgen, ruling that Sanofi and Regeneron’s PCSK9 inhibitor infringed patents on Repatha. Rather than negotiate, Sanofi and Regeneron asked Robinson to overturn the verdict, but on Tuesday she said no and on Thursday issued the ban.
Bernstein analyst Ronny Gal in a note said some investors have asked if Amgen would "dare" force Praluent off the market. He said he has no doubt that Amgen would. But “given the final outcome of the case on appeal is uncertain, there may be room for a settlement, maybe.”
Jefferies analysts were more skeptical, pointing out to clients that the appeals court that will hear the matter has not been very open to arguments that removing a drug from the market will harm the public. “As a result of the ruling, we are removing all value from Praluent starting in 2018,” they wrote.
So far U.S. sales have not been anywhere near the levels analysts had initially predicted for the new class of cholesterol drug. Analysts once predicted that Repatha and Praluent would bring in a combined $3 billion in sales by 2022. But sales have been slow out of the gate, with Repatha hitting $40 million in the third quarter of last year while Praluent brought in just $38 million.
Sales have been stifled by several factors. So far the drugs are approved only for patients with genetic conditions or for those patients who can’t tolerate other drugs for lowering cholesterol, like statins. They also have to be injected. More importantly, they cost about $14,000 a year compared with the pennies per pill that generic statins cost. As a result, payers require pre-approval before they can be prescribed.