‘Between A Rock And A Hard Place,’ Court Issues Injunction To Halt Praluent Sales

Regeneron and Sanofi have opportunity to appeal or to reach resolution with Amgen after district judge delays imposition of permanent injunction for 30 days in PCSK9 patent case.

Finding that Amgen Inc. has suffered irreparable harm from Sanofi and Regeneron Pharmaceuticals Inc.’s marketing of Praluent (alirocumab), a competitor to Amgen’s PCSK9 inhibitor Repatha (evolocumab), and that monetary damages are inadequate, a district court judge issued a permanent injunction to block US sales of Praluent.

However, in her Jan. 5 order, Delaware District Judge Sue Robinson delayed imposition of the injunction for 30 days to allow defendants the opportunity to appeal and request expedited review of the ruling by the Federal Circuit, “and/or to encourage the parties to reach an appropriate business resolution.”

The judge noted that both parties have spent billions of dollars and over a decade of work to bring their respective products to market and each would suffer hardships if she ruled for the other. She also said that the public generally is better served by having a choice of available treatments.

“Therefore, the court finds itself between a rock and a hard place, i.e., being a patent holder and a verdict winner should be a meaningful factor in the balancing test, but taking an independently developed, helpful drug off the market does not benefit the public.”

Regeneron and Sanofi announced that they will appeal the injunction, which prevents the marketing, selling or manufacturing of Praluent in the US during the term of two Amgen patents, both of which expire on Aug. 22, 2028. They will also appeal the jury verdict upholding the validity of the patents.

“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,” Sanofi Executive VP and General Counsel Karen Linehan said in a release.

Competition For Insurer Contracts, Formulary Positions

Amgen filed suit against Sanofi and Regeneron in October 2014 alleging infringement of patents covering Repatha. Prior to a jury trial the defendants stipulated to infringement of certain claims of the patents and in March a jury issued a verdict that the patents are valid. (Also see "Praluent Fate Uncertain After Amgen Wins PCSK9 Patent Battle" - Pink Sheet, 16 Mar, 2016.)

On Jan. 3, Judge Robinson denied Sanofi and Regeneron’s motions for a new trial and for a judgment as matter of law regarding the patents’ written description and enablement. (Also see "Brand vs. Brand Patent Battles Heat Up, Focus On Big Drug Classes" - Pink Sheet, 4 Jan, 2017.)

Repatha and Praluent, which lower LDL cholesterol in a select group of patients, are the only therapeutics in the PCSK9 inhibitor market. Amgen filed for approval of Repatha on Aug. 27, 2014 and received approval in August 2015. Sanofi and Regeneron filed for approval in November 2014 and used an orphan drug priority review voucher to obtain FDA approval in July 2015.

In assessing irreparable harm, Robinson noted that Amgen alleged it has been forced to compete with the defendants for contracts with insurers and exclusive formulary positions, particularly since the defendants were first to market. And Amgen said it was further harmed by defendants’ marketing of Praluent as “The First U.S. FDA-Approved PCSK9 Inhibitor.”

Sanofi and Regeneron argued that Repatha would have faced pricing pressures even without competition from Praluent.

Both drugs were priced at about $14,000 per year, a sum that has been criticized by payers and clinicians. As a result, both products have struggled to get off the ground in the US and Europe. (Also see "PCSK9 Inhibitors' First Birthday Brings Sluggish Sales And More Bad Press" - Scrip, 16 Aug, 2016.)

The PCSK9 inhibitors are approved for higher risk populations, such as patients with cardiovascular disease and genetic conditions predisposing them to very high cholesterol, like heterozygous familial hypercholesterolemia. But the sponsors hope to expend labeling with improved cardiovascular outcomes data from ongoing trials.

Repatha’s US sales for the nine months ended Sept. 30 were $65m and $18m in the rest of the world. Praluent’s net product sales for the same period were $75.7m.

Jefferies analysts said in a note that they estimate peak sales of $3.25bn for Praluent, with $750m peak tied to the current label and a further $2.5bn potential if the product gains a CV mortality claim in the future. Their estimated impact to Sanofi revenues and core earnings per share assumes that about 60% of peak sales would occur in the US in the long term and that Sanofi would be able to mitigate some of the profit impact through reduction of its sales, general and administrative expenses spend in the US.

In another note, Evercore ISI analyst John Scotti said Regeneron could take an 8% hit to its discounted cash flow if the permanent injunction stands, halting US sales of Praluent. He said Amgen would benefit from a 3% boost to its earnings per share for every $500m in additional annual Repatha sales, based on analyst estimates of sales for the PCSK9 inhibitors, which assume positive cardiovascular outcomes trial results this year.