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“We don’t want the noise about these drugs to be price,” says Leonard Schleifer, the chief executive and
founder of Regeneron. “We have to make sure that people get access to the drug for a fair price if they’re
insured, for free if they’re not insured, or at a discount if they’re under-insured.”
Praluent’s price is 46% higher than that forecast by Evercore ISI, an investment bank, and it is being approved
for a larger group of patients than many Wall Street analysts expected following a meeting convened by the
FDA to analyze the data on the drug. Some doctors argued its use should be restricted mainly to patients with
FH. But Mark Schoenebaum, Evercore ISI’s pharmaceutical analyst, says that investors were initially
disappointed because they had hoped the FDA would greenlight the drug for an even broader group. Regeneron
shares were down 2.5% in afternoon trading before they were halted pending news.
But doctors may prescribe the drug more widely than the label suggests. A survey of physicians published this
morning by Geoffrey Porges, an biotechnology analyst at investment bank Sanford C. Bernstein, found that they
would use the drug in 30% to 40% of patients who had already had heart attacks. He wrote that 2020 sales of
Praluent could be as high as $4.8 billion.
In the survey, doctors expressed a preference for Praluent. One advantage of Regeneron’s drug is that doctors
will be able to start it at a lower, 75 milligram dose.
Schleifer, who is a medical doctor and, incidentally, a billionaire thanks to his Regeneron stake, says that the
company expects that as many as 8 million people who don’t have their cholesterol well-controlled could be
candidates for Praluent. He emphasized, though, that until larger studies prove the drug prevents heart attacks
and strokes patients should always choose statins first. It will have sales representatives a
Insurance companies and pharmacy benefit managers, who help insurers and employers manage drug costs, are
going to do their best to restrict use of Praluent, though. Brennan, the CVS Caremark executive, says that he
expects patients will need to have medical records documenting that they have already taken statins. Those not
taking statins would need a blood test confirming that a statin caused elevations in muscle or liver enzymes, not
just complaints that they were achy. “We’re not trying to replace statins,” says Schleifer, the Regeneron CEO.
Most people who have muscle problems from statins do not have those elevated muscle enzymes, says Nissen,
the Cleveland Clinic cardiologist, who is conducting a clinical trial Amgen and Pfizer, which is also developing
a similar cholesterol drug. He says he has patients who are “desperate” to take a statin but who cannot tolerate
it because of muscle pain but do not have elevated muscle enzymes.

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"Dehspite significant progress over the last decades, high cholesterol remains a leading concern in the U.S. and
globally," said Olivier Brandicourt, M.D., Chief Executive Officer, Sanofi. "Praluent demonstrates the power of
the Sanofi and Regeneron alliance to deliver a first-in-class therapy in the U.S. for patients in need. Sanofi has a
strong cardiovascular heritage and dedication to these patients, and we look forward to working with other
regulatory authorities to make Praluent available to patients worldwide."
"We are grateful to the thousands of patients and investigators worldwide who participated in the ODYSSEY
clinical trial program," said Leonard S. Schleifer, M.D., Ph.D., Founder, President, and Chief Executive Officer,
Regeneron. "Praluent represents the culmination of more than a decade of tireless work to translate the genetic-
based discovery of PCSK9 into an innovative medicine that brings meaningful value to patients."
The approval of Praluent was based on data from the pivotal Phase 3 ODYSSEY program, which showed
consistent, positive results compared to placebo, which included current standard of care therapy (statins). In the
ODYSSEY LONG TERM trial which evaluated Praluent 150 mg every two weeks, Praluent reduced LDL

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