==== Amgen (AMGN) cholesterol drug cuts heart attack, stroke, but not enough to quell value debate

• New cholesterol Repatha drug lowers heart attack risk, but costs $14,000 a year A long-acting cholesterol medicine cut the risk of having a heart attack or some other serious problems by 15 to 20 percent in a big study that's likely to spur fresh debate about what drugs should cost.
• Amgen's study, known as Fourier, found no difference between Repatha patients and those taking benign placebos in terms of cardiovascular death. Repatha, however, cut down on the risk of heart attack by 27%, stroke by 21% and coronary revascularization by 22%.
• The drug was launched in 2015 and is approved for patients deemed to be at a high risk of suffering a cardiovascular event because, for instance, they have previously had a stroke or heart attack.
• There are roughly 10m people in the US who still have dangerously high levels of cholesterol despite taking a statin, according to Amgen. 
• Price: $14,000 a year for the medicine, which is intended to be taken for life, against just a few cents a day for a generic statin. 
• Repatha works by blocking the interaction between the PCSK9 protein and the LDL receptor. Doing so cuts down on the "bad" LDL cholesterol in the blood. Praluent, from Regeneron (REGN) and Sanofi (SNY), has a similar mechanism.

Repatha cut the combined risk of heart attacks, strokes and heart-related death by 20 percent compared with a placebo in patients already on high doses of cholesterol-lowering statins, such at Lipitor. Most trial subjects had had a prior heart attack or stroke.

Separately, Repatha cut heart attacks by 27 percent and stroke by 21 percent. In the second year of the study, the results were more pronounced, with a 35 percent reduction in heart attack risk and a 24 percent decrease in stroke risk.

"Just like in statin trials the benefit appeared to grow over time," said Dr. Marc Sabatine, the study's lead researcher, who presented the data at the American College of Cardiology scientific meeting in Washington.

"As a clinician this is very big news. We have another tool to significantly reduce heart attacks and stokes. That's a big win," said Sabatine from Brigham and Women's Hospital in Boston.

There was no difference in cardiovascular death in the two groups, which may disappoint some investors. Researchers said that may be due in part to the study's length, with a median duration of 26 months.

Longer term, Sabatine said, there could be a reduction in deaths as well.

The trial's primary composite goal included need for artery clearing procedures and hospitalization due to chest pains from angina in addition to heart attack, stroke and death. On that measure, the overall risk reduction was 15 percent, primarily due to no difference from placebo in angina hospitalizations.

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Repatha and rival Praluent, from Regeneron Pharmaceuticals and Sanofi, work by blocking the PCSK9 protein that prevents LDL being removed from the blood.

Repatha costs just north of $14,000 per year. Regeneron and Sanofi's Praluent costs $500 more.

Due to the high rejection rate, sales have been anemic - just $58 million for Repatha and $41 million for Praluent in the fourth quarter.

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The results of Amgen's Fourier study could be telling for drugs from rival companies, and showed up in stock action Friday. Shares of rival The Medicines Company (MDCO) dove nearly 21% at one point but settled back for an 8% loss. Nearly half of analysts see Medicines Company's cholesterol drug, Inclisiran, as having a cardiovascular benefit.


Esperion (ESPR) stock tumbled more than 30% at one point, but recovered somewhat and closed down 20.2. Only 6% of analysts expect its cholesterol drug, bempedoic acid, to have a cardiovascular benefit, according to investment bank RBC.