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Amgen's Repatha Meets Primary Endpoint in Phase III Study
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Biotech major, Amgen, Inc. (AMGN - Free Report) announced positive data from a phase III study evaluating its PCSK9 inhibitor, Repatha in patients who were receiving apheresis to help control their low-density lipoprotein cholesterol (LDL-C).
Data from the study showed that Repatha (subcutaneous) significantly reduced the need for apheresis, thereby meeting the study’s primary endpoint. The study also met its secondary endpoints. No new safety concerns were identified while the overall incidence of treatment-emergent adverse events in this study was comparable among both the arms. Full results from the study are expected at a future medical meeting.
Apheresis, an invasive procedure similar to dialysis, is a painful, time-consuming and costly one for cholesterol patients. The positive data show that Repatha, if approved for the indication, can prove to be alternative option for reducing bad cholesterol.
Amgen’s shares rose 23.8% this year so far, comparing favorably with an increase of 10.2% for the Zacks classified Biomed/Genetics industry.
Note that 2017 is proving to be a good year for Repatha.
Last month, Amgen announced that Repatha met the primary composite endpoint as well as the key secondary endpoints in a phase III cardiovascular outcomes study (FOURIER). The highly awaited top-line data from the study showed that Repatha was effective in reducing the risk of cardiovascular events (like cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke and others) in patients with clinically evident atherosclerotic cardiovascular disease. Importantly, there was no new safety finding in the trial. However, not much detail was given as the company will present detailed data from the study at the 2017 American College of Cardiology conference to be held in March.
Uptake of Repatha, which gained FDA approval in Aug 2015, has not been very encouraging so far. The commercial success of Repatha depends on the outcomes data, which looks good so far.
In Jan 2017, Amgen announced that the U.S. District Court in Delaware granted it permanent injunction against infringement by Sanofi (SNY - Free Report) and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) for two patents owned by Amgen for Repatha. The 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, 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 of Repatha.
Shares of Celgene rose 27% in the past one year while earnings estimates for 2017 rose 1.9% in the past 60 days.
Zacks' 2017 IPO Watch List
Before looking into the stocks mentioned above, you may want to get a head start on potential tech IPOs that are popping up on Zacks' radar. Imagine being in the first wave of investors to jump on a company with almost unlimited growth potential? This Special Report gives you the current scoop on 5 that may go public at any time.
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Amgen's Repatha Meets Primary Endpoint in Phase III Study
Biotech major, Amgen, Inc. (AMGN - Free Report) announced positive data from a phase III study evaluating its PCSK9 inhibitor, Repatha in patients who were receiving apheresis to help control their low-density lipoprotein cholesterol (LDL-C).
Data from the study showed that Repatha (subcutaneous) significantly reduced the need for apheresis, thereby meeting the study’s primary endpoint. The study also met its secondary endpoints. No new safety concerns were identified while the overall incidence of treatment-emergent adverse events in this study was comparable among both the arms. Full results from the study are expected at a future medical meeting.
Apheresis, an invasive procedure similar to dialysis, is a painful, time-consuming and costly one for cholesterol patients. The positive data show that Repatha, if approved for the indication, can prove to be alternative option for reducing bad cholesterol.
Amgen’s shares rose 23.8% this year so far, comparing favorably with an increase of 10.2% for the Zacks classified Biomed/Genetics industry.
Note that 2017 is proving to be a good year for Repatha.
Last month, Amgen announced that Repatha met the primary composite endpoint as well as the key secondary endpoints in a phase III cardiovascular outcomes study (FOURIER). The highly awaited top-line data from the study showed that Repatha was effective in reducing the risk of cardiovascular events (like cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke and others) in patients with clinically evident atherosclerotic cardiovascular disease. Importantly, there was no new safety finding in the trial. However, not much detail was given as the company will present detailed data from the study at the 2017 American College of Cardiology conference to be held in March.
Uptake of Repatha, which gained FDA approval in Aug 2015, has not been very encouraging so far. The commercial success of Repatha depends on the outcomes data, which looks good so far.
In Jan 2017, Amgen announced that the U.S. District Court in Delaware granted it permanent injunction against infringement by Sanofi (SNY - Free Report) and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) for two patents owned by Amgen for Repatha. The 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, 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 of Repatha.
Amgen currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the pharmaceutical sector is Celgene Corporation with a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Shares of Celgene rose 27% in the past one year while earnings estimates for 2017 rose 1.9% in the past 60 days.
Zacks' 2017 IPO Watch List
Before looking into the stocks mentioned above, you may want to get a head start on potential tech IPOs that are popping up on Zacks' radar. Imagine being in the first wave of investors to jump on a company with almost unlimited growth potential? This Special Report gives you the current scoop on 5 that may go public at any time.
One has driven from 0 to a $68 billion valuation in 8 years. Four others are a little less obvious but already show jaw-dropping growth. Download this IPO Watch List today for free >>