Sanofi, Regeneron offer price cut for cholesterol drug Praluent

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The group's analysis incorporated new clinical trial data released on Saturday showing that Praluent reduced a patient's risk of dying by 15% compared with placebo in a large trial of patients whose cholesterol exceeded medical guidelines despite already taking the standard treatment of statin drugs.

ICER often comes up with recommended prices that are far below those set by drug makers. REGN 0.27% and Sanofi SA said they will seek to renegotiate their contracts with insurers by offering rebates and discounts for the drug, called Praluent, that would bring its U.S.net price within a range of $4,500 to $8,000 annually per patient, down from its list price of $14,600.

Alirocumab was also associated with a 15 percent reduction in death from any cause, marking the first evidence that this relatively new class of drugs, called PCSK9 inhibitors, may extend lives. Despite their striking ability to lower gobs of LDL-C or "bad" cholesterol, their sales have been meager compared to Wall Street analysts' initial bullish multi-billion dollar projections; alirocumab tallied $194 million previous year worldwide, evolocumab $319 million. "Enough is enough. We're willing to work in their [price] range, providing that payers agree to reduce their burdensome barriers for patients".

Problems with patient access have been documented in numerous studies. Patients give themselves shots of the medicine once or twice a month.

Dr. Valentin Fuster, who critiqued the trial at the meeting but was not involved in the study, said the data show that what is considered normal LDL today may be too high. "It's so hard, I give up". "Many patients who have survived a recent heart attack or other coronary event are unable to reach an LDL cholesterol goal of less than 100 mg/dL, and have an urgent need for new therapeutic options due to their increased risk of another event". The study is the second of its kind-following a similar, 27,564-patient trial from Amgen past year.

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Patients with higher baseline LDL-C levels (at or above 100 mg/dL) experienced a more pronounced effect from the drug, which reduced the risk of MACE by 24 percent, and cut the risk of death from any cause by 29 percent.

Despite the widespread use of statins, heart disease remains the leading cause of death, according to the Centers for Disease Control and Prevention.

The drug, Praluent, also led to fewer deaths among high-risk patients, which could be the strongest argument for insurers to finally remove barriers that have severely constrained sales and frustrated physicians trying to get the medicine to patients. The high-risk group is the estimated 1.3 million people in the US and Europe who have had heart attacks or strokes and still can't get their LDL-C levels below 100 mg/dL of blood despite treatment with statins. "Really, it's not just a shame, it's nearly a crime to deny this drug to these patients who are at such high risk and will derive such a big benefit".

Ben Fidler is Xconomy's Deputy Biotechnology Editor.

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