Amgen Sees Positive Results in Repatha Study -- 2nd Update

By Jonathan D. Rockoff 

Amgen Inc. said Thursday that a closely watched study found the biotech's new cholesterol-lowering drug Repatha reduced patients' risk of suffering heart attacks and strokes, results the company hopes will spur sales.

The company also said the study didn't identify any new safety concerns with Repatha's use.

Aside from saying the trial met its main goals, however, Amgen didn't give any details about its findings, saying it needed to wait until the results are presented at a meeting of heart doctors next month.

Repatha, approved in July, belongs to a new class of so-called PCSK9 cholesterol-lowering agents that were expected to transform care of heart patients.

Yet its use has been less than expected, as health-insurance plans have chafed at the drug's list price of more than $14,500 a year and opted to wait for clear data showing that its cholesterol reductions actually translate into positive health benefits.

Amgen reported Repatha had just $31 million in U.S. sales in the third quarter. Nearly two-thirds of patients can't get a Repatha prescription approved by an insurer, even after filing an average of five appeals, according to Amgen.

"Now that we have outcomes data, that we've demonstrated the product is safe and has an effect, we're interested in seeing" health plans approving use of Repatha in more patients, Amgen R&D Chief Sean Harper said in an interview.

The study tested Repatha against placebo in 27,500 subjects at high risk of cardiovascular events because, for instance, they had already suffered a heart attack or stroke.

"We've unequivocally demonstrated the connection between lowering LDL with Repatha and cardiovascular risk reduction," Dr. Harper said in an interview referring to LDL, or bad, cholesterol.

The results are the latest positive development for Amgen's Repatha program. Last month, a U.S. federal judge ruled that a rival PCSK9 agent, Praluent from Sanofi SA and Regeneron Pharmaceuticals Inc., infringed Repatha's patents.

Sanofi and Regeneron have appealed the decision, as well as the judge's order that would permanently block the sale of Praluent, according to Sanofi and Regeneron spokeswomen.

Separately, Sanofi and Regeneron are conducting an outcomes trial for Praluent, also to gauge whether the drug lowered the risk of heart attacks and strokes in subjects. The companies expect to report the data from their trial by the end of the year, a Sanofi spokeswoman said.

Write to Jonathan D. Rockoff at [e-mail]

(END) Dow Jones Newswires

February 02, 2017 16:52 ET (21:52 GMT)

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