Legal

Sanofi, Regeneron win a crucial stay of execution on Praluent

Sanofi and Regeneron’s Praluent gets to stay on the market while the partners fight another day in court for the PCSK9 franchise.

Regeneron $REGN announced just after the market closed on Wednesday that the US Court of Appeals had granted a stay of a controversial decision in early January that Praluent violated Amgen’s patents on the rival PCSK9 cholesterol drug Repatha, warranting its removal from the market.

Without the stay, Praluent would have been jerked in two weeks, an extraordinarily rare move in biopharma, where patent fights are common.

According to the decision handed down today:

Rule 8(a)(2) of the Federal Rules of Appellate Procedure authorizes this court to grant a stay of an injunction pending appeal.

Our determination is governed by four factors, the first two of which are the most critical: (1) whether the movant has made a strong showing of likelihood of success on the merits; (2) whether the movant will be irreparably injured absent a stay; (3) whether issuance of the stay will substantially injure the other parties interested in the proceeding; and (4) where the public interest lies.

See Nken v. Holder, 556 U.S. 418, 434 (2009).

Without prejudicing the ultimate disposition of this case by a merits panel, we conclude based upon the papers submitted that a stay is warranted here.

Amgen says it has just begun to fight.

While we respect the Court’s decision in staying the injunction pending the appeal, Amgen remains confident in the validity of our patents and the correctness of the jury verdict and district court’s judgment.  We look forward to presenting our case on the lack of merit in Defendants’ appeal.

Now the focus shifts back to the clinic as Regeneron and Sanofi prep late-stage data on cardio outcomes, badly needed now that Amgen has declared its Phase III cardio study FOURIER a success.

There’s no data available yet, but Amgen reported that Repatha proved to significantly reduce the risk of cardio events in patients with clinically evident atherosclerotic cardiovascular disease. The drug also hit on an endpoint for cognitive function. That kind of evidence is essential if any of these players expect to earn more than the marginal sums they’ve seen so far from these two drugs. Without evidence of a real health benefit, insurers have been loathe to provide coverage. With it, they’ll find it hard to deny patients much longer.


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