Sanofi/Regeneron's Praluent Cuts Bad Cholesterol in Studies

Sanofi SNY and partner Regeneron Pharmaceuticals, Inc. REGN announced that their PCSK9 inhibitor, Praluent, significantly reduced bad cholesterol in two late-stage studies, which evaluated it in patients with diabetes and hypercholesterolemia.

In the first study - ODYSSEY DM-INSULIN - when Praluent was given in combination with maximally tolerated doses MTD of statins, it led to a significant reduction in bad cholesterol (LDL-C), thereby meeting the primary endpoint in the study.

In the second study - ODYSSEY DM-DYSLIPIDEMIA - the combination of Praluent and statins was found to be superior to usual care in reducing non-high-density lipoprotein cholesterol (non-HDL-C), another measure of bad cholesterol. The data were presented at American Diabetes Association (ADA).

So far this year, Sanofi's share price has risen 19%, better than a 10.8% increase for the Zacks classified Large-Cap Pharma industry.

Diabetes patients are at high risk of cardiovascular disease. According to Sanofi's press release, nearly 70% of diabetes patients over the age of 65 die from some form of heart disease. The positive data provided from these studies demonstrate the efficacy and safety of Praluent in this high cardiovascular risk group of patients.

Sales of PCSK9 inhibitors like Praluent and Amgen, Inc.'s AMGN Repatha have failed to impress as the drugs are facing significant payer utilization management restrictions in the U.S. Nevertheless, both companies are conducting cardiovascular (CV) outcomes studies. Positive CV outcomes data should help boost sales as it would broaden their use.

Praluent's potential to demonstrate CV benefit in patients who have experienced an acute coronary syndrome is being evaluated in the ongoing ODYSSEY OUTCOMES study. Last year, an independent Data Monitoring Committee (DMC) recommended Sanofi and partner Regeneron to continue with the study as planned instead of stopping it early.

Earlier this year, Amgen reported data from a phase III cardiovascular outcomes study (FOURIER) on Repatha, showing significant reductions in myocardial infarctions and strokes. Though data from the study looks good, it is not very clear if payers will be willing to improve access to Repatha based on this data.

Amgen is expected to file a regulatory application to include FOURIER data on Repatha's label by mid-2017.

Sanofi currently has a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here. Another stock worth considering in the large-cap pharma sector is Bayer Aktiengesellschaft BAYRY with the same rank as Sanofi.

Shares of Bayer have risen 27.6% this year while estimates for both 2017 and 2018 have risen around 2% in the past 30 days.

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