Commercialization

Amgen scores positive PhIII cardio outcomes for its PCSK9 franchise drug Repatha

Sean Harper, Executive Vice President, Research and Development

Amgen got another round of good news for its PCSK9 franchise drug Repatha. Hot on the heels of a major patent fight victory over Sanofi and Regeneron, the big pharma company says investigators garnered positive top-line cardio outcomes data from their critical FOURIER trial.

There’s no data available yet, but the company reports that Repatha proved to significantly reduce the risk of cardio events in patients with clinically evident atherosclerotic cardiovascular disease. The drug also hit on an endpoint for cognitive function.

Amgen shares surged 3.4% in after-market trading.

Amgen has had high hopes for Repatha, but sales have lagged well behind initial expectations — Q3 2016 sales were only $40 million — as payers proved reluctant to cover the drug without some clear evidence of a cardio benefit. The question now is whether Amgen can translate its data, whatever they are, into greater coverage.

The level of benefits that Amgen was looking to achieve in Fourier, though “are relatively modest, and thus, impact on sales may not be ‘transformational,’” Baird’s Brian Skorney recently noted. Analysts will get a look at the details in March, during the American College of Cardiology annual meeting.

Noted Leerink’s Geoffrey Porges:

Investors will continue to ponder the impact of modest benefit (ie 15-20% risk reduction), compared to what consensus considers a more significant benefit (20-25%) reduction, and the possibility that the company achieved a materially better than consensus outcomes benefit (>25% risk reduction).

Amgen recruited 27,500 patients for this study, an indication of what they’re willing to invest to make this drug a blockbuster. The primary endpoint was the time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary endpoint was the time to cardiovascular death, myocardial infarction or stroke.

Just a few weeks ago Amgen scored a stunning courtroom win over Sanofi and Regeneron when a federal judge banned sales of the rival PCSK9 drug Praluent. The ruling, now being appealed, said that Amgen would suffer “irreparable harm” if the competition was allowed to continue after the two companies violated the patents used to protect Repatha.

Sanofi and Regeneron have their own outcomes study underway, with data due toward the end of the year.

“In the GLAGOV study, we demonstrated that Repatha has an effect on atherosclerosis, the underlying cause of cardiovascular disease. These FOURIER results show unequivocally the connection between lowering LDL cholesterol with Repatha and cardiovascular risk reduction, even in a population already treated with optimized statin therapy,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Cardiovascular disease remains the number one health burden in the world, and we look forward to sharing these outcomes data with the scientific community at the ACC 66th Annual Scientific Session.”


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