The $1B Merck-Bayer drug that divided cardiologists in March gets priority review
Three months after Merck published in the New England Journal of Medicine data that left doctors and investors divided over just how well its experimental heart drug worked, the FDA has handed that drug priority review. A decision is now due by January 20, 2021.
Merck first announced the drug, known as vericiguat, as a Phase III success last November. In 2016, Merck had paid $1 billion upfront for US rights to the Bayer-developed drug. Early projections foresaw a few hundred million a year in sales, but the unspecified late-stage success raised the possibility for far more. After all, Novartis’s flagship heart drug, Entresto, was earning $1.7 billion per year and was expected to reach up to $4 billion in annual sales.
But when the full results came out 4 months later, doctors seemed unsure what to make of them. The trial took 5,050 patients with heart failure who were recently hospitalized, randomized them to drug or placebo, and measured as its primary endpoint how long patients went before either another hospitalization or death from a cardiovascular event.
The drug reduced the risk of such an event by 10%, the data showed. But that was primarily by a statistically significant improvement in hospitalizations alone. There were 7% fewer deaths in the drug arm, but as doctors noted, that result was not significant.
Ambiguous results from the VICTORIA trial with #vericiguat in #HFrEF @NEJM: Is your glass half empty or half full? My conclusions below! https://t.co/wiHmjp3unF
1. Nothing in there for mortality reduction. Trial was even overpowered, KM curves are superimposed! pic.twitter.com/pjHnuAWxAg
— Frederik H. Verbrugge (@FH_Verbrugge) March 28, 2020
Although investigators often caution against cross-trial comparisons, recent cardiovascular drugs notably saw much stronger reductions in deaths or hospitalizations than Merck’s. Entresto had a 20% overall reduction in its major trial and Eli Lilly’s Jardiance had a 26% reduction. In a webcast for the American Journal of Managed Care, though, University of Mississippi College of Medicine chair Javed Butler argued that the Merck trial had a shorter follow-up period and that, though the relative risk reduction may have looked modest, the absolute risk reduction was in line with trials for other drugs, around 4%.
SVB Leerink’s Daina Graybosch wrote the results pointed to a “niche” market for those who can’t tolerate the current standard-of-care. Cowen’s Steve Scala, who had raised the possibility of a more-lucrative-than-anticipated product after the November announcement, pegged $500 million in peak sales following the NEJM publication, writing that “investor expectations were definitely missed.”
“MRK’s current strength — thanks to Keytruda and Vaccines — is clear,” Scala wrote, “but the oxygen for drug manufacturers are pipelines, and MRK’s appears insufficient, raising potential for significant M&A.”