Regeneron Pharmaceuticals, Inc. REGN and Sanofi SNY announced positive data from a phase III study (ODYSSEY ESCAPE) on its cholesterol-lowering drug, Praluent, for the treatment of patients with heterozygous familial hypercholesterolemia (HeFH).
The placebo-controlled phase III study evaluated patients with HeFH, whose cholesterol levels required chronic, weekly or bi-weekly apheresis therapy. Data from the study demonstrated that patients who added Praluent to their existing treatment regimen, showed a 75% reduction in the frequency of their apheresis therapy in comparison to placebo. Moreover, about 63% of patients treated with the drug did not require apheresis, compared to zero percent of patients in the placebo arm. Detailed results from the study will be presented at future medical congresses.
We note that Praluent is currently approved in the U.S. as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of low-density lipoprotein (LDL) cholesterol. The drug is also approved in the EU for the treatment of adults with primary hypercholesterolemia (HeFH and non-familial) or mixed dyslipidemia. For the full year, Praluent generated sales of $11 million.
We remind investors that earlier this month, Regeneron and Sanofi announced that they strongly disagree with a U.S. District Court jury verdict that the asserted claims of two of Amgen, Inc. AMGN patents for antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) were valid. They believe these Amgen patent claims are invalid in the U.S. patent infringement lawsuit and plan to appeal the judgment. The companies further noted that the decision has not affected their ability to sell their PCSK9 inhibitor, Praluent.
Regeneron currently holds a Zacks Rank #5 (Strong Sell), while Sanofi has a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is AMAG Pharmaceuticals, Inc. AMAG, with 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 >>
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
Be the first to comment