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Regeneron/Sanofi Present Positive Phase III Praluent Data
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and Sanofi (SNY - Free Report) announced detailed results from a completed placebo-controlled phase III study, ODYSSEY ESCAPE, which evaluated its PCSK9 inhibitor, Praluent, in patients with an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH), who required regular weekly or bi-weekly apheresis treatment.
Data from the study showed that Praluent, when added to existing therapy, reduced low-density lipoprotein cholesterol (LDL-C) roughly 50% from baseline in comparison to a 2% increase in the placebo arm. In addition, Praluent significantly reduced the need for apheresis treatment by 75% compared to placebo, thereby meeting the primary endpoint of the study.
Other key results of the study indicated that throughout the study, patients on Praluent witnessed significant reductions in their LDL-C starting week 6 (55% greater reduction compared to placebo), continuing until week 18 (46% greater reduction compared to placebo). On the safety front, a similar proportion of patients experienced adverse events in both the Praluent and placebo arms (76% for both groups).
ODYSSEY ESCAPE study data were presented at the European Society of Cardiology (ESC) Congress and were concurrently published in the European Heart Journal.
Considering that apheresis therapy is an invasive, time-consuming and expensive treatment for some of the most difficult-to-treat patients with very high cholesterol unable to achieve their cholesterol-lowering goals on any other therapy, the phase III study data are encouraging. These results indicate that Praluent can used for overall management of patients with HeFH undergoing regular apheresis therapy, with the potential to minimize the need for difficult apheresis treatments.
Meanwhile, Praluent’s potential to demonstrate cardiovascular (CV) benefit in patients who have experienced an acute coronary syndrome is being evaluated in the ongoing ODYSSEY OUTCOMES study.
Amgen Inc. (AMGN - Free Report) also presented data on its PCSK9 inhibitor, Repatha, at the ESC Congress. Data presented showed that Repatha consistently reduced LDL-C in patients across CV risk subgroups or with HeFH.
We note that sales of both Repatha and Praluent are yet to pick up with the drugs facing a difficult access and reimbursement environment among other factors. Nevertheless, positive CV outcomes data should help boost the drugs’ sales. Amgen expects to report top-line data from its Repatha outcomes study in the first quarter of 2017.
Regeneron is a Zack Rank #2 (Buy) stock, while Sanofi carries a Zack Rank #4 (Sell). ANI Pharmaceuticals, Inc. (ANIP - Free Report) is a well-placed stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy).
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Regeneron/Sanofi Present Positive Phase III Praluent Data
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and Sanofi (SNY - Free Report) announced detailed results from a completed placebo-controlled phase III study, ODYSSEY ESCAPE, which evaluated its PCSK9 inhibitor, Praluent, in patients with an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH), who required regular weekly or bi-weekly apheresis treatment.
Data from the study showed that Praluent, when added to existing therapy, reduced low-density lipoprotein cholesterol (LDL-C) roughly 50% from baseline in comparison to a 2% increase in the placebo arm. In addition, Praluent significantly reduced the need for apheresis treatment by 75% compared to placebo, thereby meeting the primary endpoint of the study.
Other key results of the study indicated that throughout the study, patients on Praluent witnessed significant reductions in their LDL-C starting week 6 (55% greater reduction compared to placebo), continuing until week 18 (46% greater reduction compared to placebo). On the safety front, a similar proportion of patients experienced adverse events in both the Praluent and placebo arms (76% for both groups).
ODYSSEY ESCAPE study data were presented at the European Society of Cardiology (ESC) Congress and were concurrently published in the European Heart Journal.
Considering that apheresis therapy is an invasive, time-consuming and expensive treatment for some of the most difficult-to-treat patients with very high cholesterol unable to achieve their cholesterol-lowering goals on any other therapy, the phase III study data are encouraging. These results indicate that Praluent can used for overall management of patients with HeFH undergoing regular apheresis therapy, with the potential to minimize the need for difficult apheresis treatments.
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Meanwhile, Praluent’s potential to demonstrate cardiovascular (CV) benefit in patients who have experienced an acute coronary syndrome is being evaluated in the ongoing ODYSSEY OUTCOMES study.
Amgen Inc. (AMGN - Free Report) also presented data on its PCSK9 inhibitor, Repatha, at the ESC Congress. Data presented showed that Repatha consistently reduced LDL-C in patients across CV risk subgroups or with HeFH.
We note that sales of both Repatha and Praluent are yet to pick up with the drugs facing a difficult access and reimbursement environment among other factors. Nevertheless, positive CV outcomes data should help boost the drugs’ sales. Amgen expects to report top-line data from its Repatha outcomes study in the first quarter of 2017.
Regeneron is a Zack Rank #2 (Buy) stock, while Sanofi carries a Zack Rank #4 (Sell). ANI Pharmaceuticals, Inc. (ANIP - Free Report) is a well-placed stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>