Pharma, R&D

Praluent Odyssey: Regeneron/Sanofi gun for market breakout with first-ever mortality benefit — and a big price discount

Few drug rivalries have been carried out with more direct, hand-to-hand fighting than the scrap over the PCSK9 market. Marginal as the market is now, the combined forces of Regeneron and Sanofi allied against Amgen have nevertheless punched it out in court and the playing field in the devout belief that billions are at stake. And all three have had to struggle with a payers’ backlash against the two drugs they’re selling.

Now Regeneron/Sanofi are launching a full scale assault, armed with new data from the 18,924-patient Odyssey Outcomes study highlighting groundbreaking evidence of a mortality benefit for Praluent that they believe will give them an edge. And they’re following through by dramatically marking down the public price they are proposing to charge for payers willing to finally dismantle the hurdles they’ve erected to stop their members from taking their cholesterol treatment.

Just as Amgen won kudos for its work to convince payers to do the same with money-back guarantees, this new round marks the industry’s increasing willingness to negotiate over what it charges — a trend that is creating a sea change over some drugs that have to survive in a competitive scene.

First, here’s the long-awaited Odyssey Outcomes data, released at the American College of Cardiology’s scientific meeting in Orlando.

Researchers say they have conclusive evidence that Praluent not only significantly reduced the number of cardio incidents experienced by patients on the LDL drug, with the vast majority also on high-intensity statins, they also have a clear reduction in deaths — the goal that eluded Amgen when it floated their Fourier data last summer.

— Looking at MACE (Major Adverse Cardiac Events) among patients with an LDL level over 100 mg/dL, there was a drop of 3.4 points between the placebo arm and Praluent rates — 14.9% to 11.5%, a risk reduction of 24%.

— For CV death the rate dropped from 4.2% to 2.9%.

— And for all-cause deaths the decrease was 5.7% to 4.1%, with a 1.7 point drop; a 29% drop in risk.

To put it another way, for every 1,000 patients who met this profile and were on drug, 17 people would still be alive. And that, say the partners, should be the telling difference for payers.

To drive that message home, Sanofi today has agreed to cut their price of Praluent to $4,460 to $7,975 a year for payers who are willing to stop throwing up roadblocks to this drug, dropping to a price that on the low end is not much higher than the $10-a-day cost of the old generation of statins before they went generic. At the high end, it still marks a sharp drop from the $14,000 wholesale price that had been the market standard used to peg discounts against.

“Too many patients in urgent need of additional treatment options on top of statins have faced tremendous hurdles to gain access to this important medicine. We are prepared to change this by improving access and affordability, eliminating these burdensome barriers for high-risk patients in need,” said Sanofi CEO Olivier Brandicourt in a statement. “We will begin working with payers to ensure that high-risk patients have appropriate access. This is the right thing to do for patients.”

That was not an easy concession for Sanofi, but these drugs are earning only a fraction of what analysts had expected.

At this point, there’s virtually no question that these drugs work as billed, slashing LDL levels safely. In fact, many analysts would also tell you that they are remarkably similar. Perhaps they were a little too similar for a judge who once ordered Regeneron and Sanofi to yank their drug during their court battle with Amgen over the patents involved. That ruling was overturned, but the legal fight continues.

Regeneron/Sanofi are coming out with a differentiated profile now, though, after Amgen hustled its Repatha outcomes data out last year, trumpeting significant reductions in cardio events but no mortality benefit. And payers remained unimpressed.

Why did Odyssey Outcomes succeed on that mortality score?

Bob Pordy, the vice president of cardiovascular and metabolism therapeutics at Regeneron, says you can mark that down to the fact they focused on a group of ACS patients who were by far at the highest risk, with a significantly longer duration of treatment in the study.

“Odyssey Outcomes studied Praluent in the highest risk patients,” echoes Jay Edelberg, Sanofi’s head of cardio development. “They remain at high risk of recurring heart attacks. By studying these highest risk patients, we were able to demonstrate reductions in MACE and a reduction in mortality.”

While most of the attention in the cholesterol market has centered on the two PCSK9 drugs, the two key companies aren’t alone here. Esperion CEO Tim Mayleben has made it clear that they plan to charge under $4,000 for their late-stage cholesterol pill, now in late-stage development. That price point may not look like so much of a bargain now. And The Medicines Company has been putting all their eggs in one RNAi basket on LDL cholesterol as well, which may also face altered prospects.

This kind of public discussion about retail drug prices is a remarkable change for an industry that has benefited enormously by keeping their true prices as opaque as possible. But now data aren’t enough, as payers find new ways to put some distance between themselves and the mass market drugs that threaten to eat into their margins.

Now you also have to publicly compete on the sticker price, on occasion.

Image: Sanofi CEO Olivier Brandicourt on January 31, 2018  Aleksey Nikolskyi/Sputnik via AP

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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