Amgen Wins Trial Against Regeneron and Sanofi for Cholesterol Drug Patents, Appeal Likely

Published: Mar 18, 2016

Amgen Wins Trial Against Regeneron and Sanofi for Cholesterol Drug Patents, Appeal Likely
March 17, 2016
By Mark Terry, BioSpace.com Breaking News Staff

Thousand Oaks, Calif.-based Amgen announced yesterday that a jury in Delaware district court came down on the company’s side, defending Amgen’s two patents being contested by Paris-based Sanofi and its partner, Tarrytown, N.Y.-based Regeneron Pharmaceuticals .

Ultimately, the jury ruled that two of Amgen’s patents on its cholesterol drug Repatha were valid. Sanofi and Regeneron have a cholesterol drug, Praluent, that uses a similar mechanism of action.

“This decision is the first step in this ongoing litigation,” wrote Sanofi and Regeneron in a statement, “and does not impact Praluent (alirocumab) Injection or our ability to deliver it to physicians and patients at this time.”

Basically, Sanofi and Regeneron were claiming that Amgen’s patents for antibodies that targeted PCSK9 were so broad as to be meaningless. Both companies’ drugs were approved in the summer of 2015 by the U.S. Food and Drug Administration (FDA).

Although some analysts feel the drugs have the potential to be blockbusters because of their effectiveness at reducing cholesterol in patients who have difficult-to-control cholesterol, the uptake has been slow primarily due to their prices, which are around $14,000 annually. The current standard treatment for high cholesterol is statins, which typically cost about $50 per month, and are considered to be very effective in most patients. Additional trials are also pending to connect the dots between lowering cholesterol and also cutting the risk of heart attacks and strokes.

Sue Robinson, the U.S. District Judge who presided over the trial, will make a decision on whether to issue a permanent injunction preventing Sanofi/Regeneron from selling Praluent. A more typical response would be to force the two companies to pay royalties to Amgen on sales of Praluent. That decision is scheduled for March 23 to 24. Sanofi/Regeneron has stated that it plans to appeal the most recent jury verdict.

“A permanent injunction is unlikely,” said Tim Race, an analyst with Deutsche Bank in a research note. “However, the likelihood of settlement has now increased substantially with Sanofi and its partner Regeneron potentially forced to pay royalties.”

It was noted by Mark Schoenebaum, an analyst with Evercore ISI, that in 2012 Regeneron settled a patent dispute with Roche /Genentech over an eye drug, and agreed to pay a five-percent royalty. If that same figure were applied to Amgen, it would, as reported by Xconomy, “present about $106 million of Regeneron’s U.S. alirocumab sales in 2020.”

Regeneron and Sanofi coughed up $67.5 million in 2014 for a voucher that pushed the FDA review of alirocumab up, giving it a little bit of a head start against Amgen. Amgen’s lawsuit was filed in 2014 and both drugs hit the market in the U.S. and Europe last summer.

“This increases the likelhood of a settlement,” wrote Michael Yee, an RBC Capital Markets analyst in a note to clients “where Sanofi/Regeneron may owe a 5-10 percent royalty to Amgen. However, today’s ruling is only a first step.”

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