Regeneron Pharmaceuticals and Sanofi Grab Another Important Win

Source: Regeneron.

Investors in healthcare giants Regeneron Pharmaceuticals (REGN +0.00%) and Sanofi (SNY +0.00%) were given another reason to smile earlier today as the companies officially announced that the European Commission has granted them the right to begin marketing Praluent, their new cholesterol-lowering medication, for sale. 

News of an approval is always good, but investors largely yawned in reaction (in fact, the companies' share prices declined yesterday as part of a broader market sell-off), as they were rightly expecting an easy approval. Praluent has already been given the green light for use in the U.S., and the European Committee for Medicinal Products for Human Use, or CHMP, previously recommended that Praluent should get approval earlier in the year.

Praulent is the second drug in a new class of medicines known as proprotein convertase subtilisin/kexin type 9, or PCSK9, inhibitors that is now available for sale in the region. PCSK9 inhibitors have shown terrific clinical results for helping patients with hypercholesterolemia, or high levels of cholesterol in the blood. Many patients have been unable to reach their goals despite using lipid-lowering therapies such as statins, and it is this group that stands to benefit the most from PCSK9 inhibitors.

Huge problem = huge opportunity
High cholesterol is a very serious concern in Europe, as the World Health Organization estimates that 54% of Europeans have high cholesterol, which is the greatest prevalence in the world. Since high LDL-cholesterol levels are a significant contributor to cardiovascular disease, which itself is the leading cause of death worldwide, it appears that PCSK9 inhibitors could really help to improve health in the region.

While it has yet to be determined if Praluent can help to lower deaths from cardiovascular disease, the companies are currently running studies to determine if there is a link, and early results look quite promising. In pre-specified final analyses of their ongoing ODYSSEY study, serious cardiovascular events were reported in only 1.7% of patients taking Praluent, which compared very favorably to the 3.3% reported in patients taking a placebo instead.

While the official results won't be released until 2017, those early numbers certainly look quite promising, and they could lead to expanded labeling for PCSK9 inhibitors down the road.

Competition is about to get fierce
Of course, while this news is great for Regeneron and Sanofi shareholders, they certainly won't have the PCSK9 inhibitor market all to themselves. The first PCSK9 inhibitor to get approval in Europe was Repatha, a PCSK9 inhibitors that is marketed by biotech blue-chip Amgen, which managed to get approval in July of this year.

Both drugs have been priced aggressively -- the wholesale cost of using either of these drugs for a year is over $14,000. Understandably, many pharmacy benefit managers and insurers are very worried about what these drugs will do to levels of spending on healthcare, and they have been sounding the warning bells. Now that European countries have two approved drugs to pick from, it's likely they will argue hard for favorable pricing terms. Still, even if the drugmakers bend on pricing, the market opportunity looks so large that both drugs could still easily reach blockbuster status in the future.

Should you buy on the news?
This news was certainly expected and, arguably, priced into both stocks, so it's no surprise to see that neither stock reacted in a positive way to today's announcement. Still, an approval is an approval, and I think investors in either of these companies should be cheering the news. Given the bloodbath that biotech stocks in general have been experiencing the past few days, now might be a good time to add one of these stocks to your portfolio.