Amgen Files For Repatha In The U.S., EU For Expanded Use

Biotech major Amgen, Inc. (NASDAQ:AMGN) announced that it submitted regulatory applications for its PCSK9 inhibitor, Repatha in both the U.S. and EU. The submissions seek to include data from a phase III cardiovascular outcomes study (FOURIER) showing significant reductions in myocardial infarctions and strokes compared with the current best therapy alone.

The company submitted a supplemental biologics license application (sBLA) to FDA and a variation to the marketing authorization at European Medicines Agency (EMA) for Repatha. Data from the study showed that Repatha lowers LDL-C or bad cholesterol to unprecedented low levels, resultsing in meaningful cardiovascular benefit in patients with clinically evident atherosclerotic cardiovascular disease.

The study demonstrated that Repatha treatment led to a 15% reduction in primary endpoints of risk of major adverse cardiovascular events (MACE), including hospitalization for unstable angina, coronary revascularization, heart attack, stroke or cardiovascular death.

Notably, Repatha gained an FDA approval in Aug 2015, for treatment of patients, incapable of managing their LDL cholesterol at acceptable levels. It is approved in over 50 countries, including the U.S., Japan, Canada and overall, 28 member countries of the European Union for the given indication.

Amgen’s share price movement shows the stock to outperform the Zacks classified Medical - Biomedical and Genetics industry so far this year. The stock gained 9.6% compared to industry’s increase of 2.8% during the period.

Regarding the FOURIER study data, Repatha significantly reduced risk of hard MACE (heart attack, stroke or cardiovascular death) by 20% compared to the standard treatment with statin therapy. For individual components, risks of heart attack, stroke and coronary revascularization were nominally reduced by 27%, 21% and 22%, respectively, with Repatha.

However, Repatha did not show any improvement in cardiovascular death risk, which has raised investor concerns.

Meanwhile, a monthly administration of single-dosing option for Repatha (Pushtronex) is approved in the U.S. and the EU, thus making it the first and only PCSK9 inhibitor to have a monthly single-dose delivery option.

Better to remind investors that in Jan 2017, Amgen has announced granting of permanent injunction by the U.S. District Court in Delaware against infringement by Sanofi (NYSE:SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) for two patents that it owned for Repatha.

This decision bans Sanofi and Regeneron from selling Praluent during the term of the two patents, which describe and claim monoclonal antibodies of PCSK9. Regeneron and Sanofi however have appealed against the ruling in a higher court.

The appeals court granted their request to stay (suspend) the permanent injunction, pending the outcome of the appeal. Praluent’s ban could in turn drive sales for Repatha.

Zacks Rank & Key Picks

Amgen currently carries a Zacks Rank #3 (Hold). A better-ranked stock in healthcare sector includes VIVUS, Inc. (NASDAQ:VVUS) , that flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’ loss per share estimates diminished from 50 cents to 39 cents for 2017 in last 30 days. The company posted positive earnings surprises in all four trailing quarters with an average beat of 233.69%.

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