Regeneron Pharmaceuticals, Inc. REGN and its partner Sanofi SNY announced that 18-month data from a phase III study (n = 2,341) on their PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody, Praluent were published online in The New England Journal of Medicine.
The phase III ODYSSEY LONG TERM study compared the use of Praluent 150 mg every two weeks to placebo in patients who were at high cardiovascular (CV) risk and who were receiving maximally-tolerated statin therapy with or without other lipid lowering treatment. The study also included patients with heterozygous familial hypercholesterolemia.
At week 78, 56% reduction from baseline in low-density lipoprotein-cholesterol was observed in patients receiving Praluent as compared to placebo. Efficacy of Praluent remained consistent throughout treatment. At week 78, positively adjudicated pre-specified CV adverse events occurred in 4.6% patients on Praluent and 5.1% of patients on placebo. Fewer major cardiovascular events (including coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) observed with Praluent in post hoc analysis.
Regeneron and Sanofi are looking to get the candidate approved for the treatment of patients suffering from hypercholesterolemia. We remind investors that Regeneron and Sanofi had announced that the regulatory application for Praluent was accepted for priority review by the FDA. The FDA is expected to render a final decision by Jul 24, 2015. Meanwhile, the European Medicines Agency has also accepted the marketing authorization application for Praluent.
We remind investors that Amgen Inc. AMGN has filed a lawsuit against Sanofi and Regeneron in the U.S. District Court of Delaware. Amgen through this lawsuit is looking to prevent the manufacture, use and sale of Praluent.
Amgen is seeking FDA approval for its PCSK9 inhibitor, Repatha. Amgen was the first to submit a BLA for a PCSK9 inhibitor. We note that several other companies are also developing their own PCSK9 inhibitors.
Regeneron and Sanofi both currently carries a Zacks Rank #4 (Sell). Acorda Therapeutics, Inc. ACOR is a better-ranked stock in the health care sector sporting a Zacks Rank #1 (Strong Buy).