Biopharmaceutical company Regeneron Pharmaceuticals (REGN 0.63%) has grown into a $50 billion-market cap behemoth thanks to the strong sales of its blockbuster drug Eylea, which treats several blindness-causing retinal conditions. However, the company may soon have another blockbuster drug on its hands, as the FDA will be making a decision about the approval of cholesterol-lowering medicine Praluent later this month.
In partnership with fellow healthcare giant Sanofi, the company submitted Praluent for FDA approval in January of this year, and the application was granted priority review status. A target date of July 24th, 2015, was set for a decision.
The company has a strong reason to believe the FDA will give Praluent the green light. In June, the Endocrinologic and Metabolic Drugs Advisory Committee at the FDA recommended the approval of the drug. While a recommendation does not always lead to an approval, it certainly is a positive sign.
The LDL problem
High cholesterol levels are a huge problem in the U.S., and the Centers for Disease Control and Prevention estimates that more than 73 million Americans have high levels of LDL -- the bad type of cholesterol. Less than half of adults with high LDL cholesterol are currently receiving treatment to lower their levels.
Even among patients currently taking medication, many are still falling short of their goals. In the U.S. alone, there are 11 million high-risk patients using medication who have still failed to reach their cholesterol targets. The risks associated with high LDL levels are quite serious, as there is a strong relationship between high LDL cholesterol levels and cardiovascular risks, which is the No. 1 cause of death in the U.S.
Praluent has the potential to help many of these patients who are not yet at their goal, as the drug is a different type of medication than currently available treatments. Praluent is a PCSK9 inhibitor that works to help the liver remove more LDL from the body as opposed to the current standard of care, statins, which work to lower LDL production.
A recent study showed that using Praluent alongside statins reduced LDL cholesterol levels by an astounding 64% more than just using statins alone. That is a significant benefit, suggesting that the medication could go a long way toward helping millions of patients better control their cholesterol levels.
If the FDA does give the thumbs up to Praluent, Regeneron could have another blockbuster on its hands, as peak sales estimates for the drug are currently running in the multibillion-dollar range. Considering total 2014 revenue for Regeneron was $2.8 billion, Praluent could have a significant impact on the company's financials if it can live up to its full potential.
The market is certainly aware of the potential for Praluent and has been bidding the stock up accordingly. Shares are up more then 60% in the last 12 months alone.
While the market potential for Praluent looks to be quite bright, investors need to be aware of another LDL-lowering medication that could also be right around the corner from approval. Biotech giant Amgen has its own PCSK9 inhibitor called Repatha. The FDA is currently reviewing the drug for approval and has set a decision date of August 27th, 2015, barely more than a month after the Praluent decision date.
The market for PCSK9 inhibitors like Praluent and Repatha appears to be huge, so even with a direct competitor, Praluent could still hold blockbuster potential. However, investors would still be wise to keep a close eye on the progress of Repatha.
If Praluent can gain approval in the coming weeks, there's a good chance Regeneron will continue to grow at a very healthy rate. It looks like we'll have our answer either way in a few short weeks.