Praluent’s revenue trends
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) share the profits and losses from Praluent’s revenue. In 2016, Regeneron Pharmaceuticals’ Praluent reported revenue of ~$116.3 million, compared to $10.5 million in 2015. In 2016, Praluent generated revenue of ~$94.4 million in the US market.
In 1Q17, Praluent generated revenue of ~$36 million, compared to $13 million in 1Q16. However, in 1Q17, the drug witnessed a ~12% fall on a quarter-over-quarter basis.
The above graph represents Praluent’s revenue curve from 1Q16 to 1Q17. To know more about Praluent, read Regeneron’s Praluent May See Gradual Increase in 2017 Demand.
About Praluent (alirocumab)
Praluent is used as an addition to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require further lowering of low-density lipoprotein (or LDL).
In April 2017, the FDA approved Regeneron Pharmaceuticals’ and Sanofi’s new supplemental Biologics License Application (or sBLA) for a Praluent 300mg (milligram) once-monthly dose for the treatment of individuals with high LDL cholesterol. In November 2016, Regeneron and Sanofi received the European Commission’s (or EC) approval for the 300mg Praluent injection. The EC and FDA approvals were granted based on the results of the Phase 3 ODYSSEY CHOICE I trial.
The Phase 3 ODYSSEY CHOICE I trial evaluated the safety and efficacy of the 300mg Praluent injection compared to a placebo in patients with hypercholesterolemia who were taking an associated statin. The 300mg Prajuent injection is administered via two 150mg injections at two different injection sites.
The availability of Praluent in two dosing options (75mg and 150mg) should help physicians to select doses based on patients’ conditions. Currently, Praluent is the only PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor that’s available with two levels of efficacy, that is, 75mg and 150mg dosages.
Regeneron and Sanofi are also conducting a Phase 3 ODYSSEY OUTCOMES trial to evaluate the effects of Praluent on the occurrence of cardiovascular events in individuals who had acute coronary syndrome events at least 4 to 52 weeks before randomization and were treated with evidence-based clinical management of dyslipidemia.
Praluent faces stiff competition from Amgen’s (AMGN) Repatha. Notably, the Vanguard Health Care ETF (VHT) has ~1.1% of its total portfolio in Regeneron Pharmaceuticals. Pfizer (PFE), a leader in the cardiovascular drug market, makes up ~5.5% of VHT’s total portfolio holdings.