Amgen, Inc. (AMGN - Free Report) announced a new analysis from the phase III cardiovascular outcomes study (FOURIER) on its PCSK9 inhibitor, Repatha.
This analysis of a large cohort of patients with established atherosclerotic cardiovascular disease showed that there was a strong progressive relationship between lower achieved levels of LDL-C or “bad” cholesterol and a lower risk of cardiovascular events rates. This analysis suggests that the use of intensive LDL-C therapies such as Repatha in high-risk cardiovascular patients can safely reduce the risk of another cardiovascular event like heart attack, stroke or cardiovascular death.
This year so far, Amgen’s shares are up 17.5%, better than the 7.2% increase registered by the industry.
The results were presented at the European Society of Cardiology (ESC) Congress held in Spain and also published in The Lancet.
We remind investors that data presented from FOURIER in March this year had revealed that treatment with Repatha led to a significant reduction in myocardial infarctions and strokes.
Uptake of the drug, which gained FDA approval in Aug 2015, has not been very encouraging so far due to pricing and re-imbursement issues/payer restrictions. The FOURIER data holds the key to the commercial success of Repatha as it will broaden the use of the drug. Though data from the study looks good, it is not very clear if payers will be willing to improve access to Repatha based on this data.
Encouragingly, at the second quarter conference call, management said that Repatha holds 58% share of the PCSK9 segment in the U.S. and Europe, with share trends improving sequentially in both the markets in the quarter. Meanwhile, in the U.S., the new-to-brand share for Repatha was 70% in the second quarter. Management said that the presentation of the outcomes study data had a positive impact on Repatha share trends.
Amgen filed regulatory applications in both the U.S. and EU to include FOURIER data on Repatha’s label in Jun 2017. Last month, Amgen announced that the FDA has granted priority review foritsregulatory application seeking approval to include FOURIER data on its label. A decision from the agency is expected on Dec 2, 2017.
Sanofi (SNY - Free Report) and partner Regeneron Pharmaceuticals, Inc. (REGN - Free Report) also faced similar issues with their PCSK9 inhibitor, Praluent.
Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
A better-ranked pharma/biotech stock is Gilead Sciences, Inc. (GILD - Free Report) with a Zacks Rank #2 (Buy).
Shares of Gilead are up 4.3% so far this year while estimates for 2017 and 2018 have inched up almost 07% and 0.1%, respectively over the last 30 days.
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