Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and Sanofi (SNY - Free Report) announced that an independent Data Monitoring Committee (DMC) has recommended the continuation of the phase III ODYSSEY OUTCOMES study on their PCSK9 inhibitor, Praluent. While the DMC’s recommendation followed the completion of a second pre-specified interim analysis, the committee will continue to examine the ongoing safety and efficacy of Praluent as planned.
The multi-center, randomized, double-blind, placebo-controlled ODYSSEY OUTCOMES study is being conducted to evaluate the effect of Praluent on cardiovascular (CV) events in high-risk patients. Patients who entered the study experienced a heart attack or unstable angina requiring hospitalization within a year of enrolment, and were unable to control LDL cholesterol despite being treated with maximally tolerated statins and other lipid-lowering therapies.
Had Praluent demonstrated an overwhelming efficacy at the interim stage, the DMC would have recommended early conclusion of the study, giving Regeneron and Sanofi an edge in the PCSK9 sales market, which also has Amgen Inc.’s (AMGN - Free Report) Repatha. Regeneron and Sanofi will now have to wait until the final data readout in order to get the much needed sales boost, which an early conclusion could have provided. ODYSSEY OUTCOMES is expected to be complete in 2017. Regeneron’s shares were down 3.7% on the news.
REGENERON PHARM Price
Prospects of PCSK9 inhibitors, a new class of cholesterol-lowering treatments with blockbuster potential, had gained instant popularity before hitting the market last year. However, sales of both Praluent and Repatha have failed to impress as the drugs are facing significant payer utilization management restrictions in the U.S. and limited market access in Europe.
All the three companies believe that positive CV outcomes data will help drive sales of this class of treatments. Amgen expects to report top-line data from its outcomes study FOURIER in the first quarter of 2017.
Earlier this week, Amgen announced detailed results of the phase III GLAGOV coronary intravascular ultrasound imaging study on Repatha. Data showed that Repatha, when added to optimized statin therapy, resulted in a statistically significant regression of atherosclerosis in patients with coronary artery disease. Results were presented at the American Heart Association Scientific Sessions and published in the Journal of the American Medical Association.
While Regeneron is a Zacks Rank #2 (Buy) stock, Sanofi carries a Zacks Rank #3 (Hold).
A Stock to Consider
Anika Therapeutics Inc. (ANIK - Free Report) is a favorably placed stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has gained 18% year to date.
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