SAN FRANCISCO—Back in November, news of a cardiovascular outcomes win for Trulicity pleased Eli Lilly investors whom analysts called “skeptical.” Now, those same skeptics may wonder just how well Trulicity’s performance can help it fend off new competition from Novo Nordisk.
Sunday at the annual Scientific Sessions of the American Diabetes Association (ADA) in San Francisco , the Indianapolis drugmaker unveiled data showing Trulicity had pared down the combined rate of heart attack, stroke and cardiovascular death by 12%. While Trulicity produced numerical benefits in each of those categories, only stroke was statistically significant.
The win puts Trulicity in a small group of GLP-1 drugs that have posted heart-helping benefits for patients. The thing is, Novo Nordisk’s weekly Ozempic—whose active ingredient, semaglutide, the Danish drugmaker is also developing in pill form—is also part of the group, and it showed in 2016 that it could cut cardiovascular problems by 26%.
Lilly’s numbers are lower than some analysts and investors expected to see. “On efficacy hazard ratio, I doubt Lilly would have used the word ‘compelling’ without the HR being at least in the semaglutide-like range at least,” Evercore ISI’s Umer Raffat wrote after top-line results made their debut.
"We believe investors may have been hoping for a greater risk reduction," Credit Suisse analyst Vamil Divan wrote in a Monday note to clients, with Bernstein's Wimal Kapadia adding that, "Trulicity delivered but it underwhelmed."
As Lilly was quick to point out, though, its outcomes trial, dubbed Rewind, bore some key differences to Novo’s. For one, the majority of participants—about 69%—didn’t have already-established cardiovascular disease, a claim Lilly’s rivals can’t make.
Rewind also ranks as the class’ longest cardiovascular outcomes trial to date, with an average follow-up of 5.4 years, and it enrolled a balanced ratio of women and men. And its benefits stayed consistent across various subgroups, Brad Woodward, Lilly's global development leader for incretins, pointed out.
“We have a population that really is broad and representative of patients that are treated for Type 2 diabetes,” he said, adding that “we believe that effect is consistent across the groups and meaningful for patients who are being seen in physicians’ offices today.”
Plus, as Divan and Kapadia see it, specific risk-reduction figures aren't all that important to Lilly's market-share battle.
"We think the precise details are less important here given growth of the GLP-1 class is being driven by primary care physicians whose prescribing decisions are often less data driven and impacted by factors such as formulary positioning and the injection device," Divan wrote.
And "physicians will see a broad CV claim as a class effect," Kapadia noted. "In short, we expect Trulicity to benefit but not at the expense of Ozempic."
Lilly will be working to get the data on Trulicity’s label as quickly as possible, with oral semaglutide making its way toward the market to threaten the pharma giant's share. The company has already submitted Rewind in both the U.S. and Europe, and Lilly looks “forward to the regulatory review process,” Woodward said.
Meanwhile, though, it’s also working on a candidate that could shake up the GLP-1 market altogether. Also at ADA, Lilly added more data for tirzepatide, a GIP/GLP-1 dual receptor agonist that could spur the market to “bifurcate over time,” Kapadia wrote to clients earlier this month.
Kapadia models Lilly eventually taking “the larger share of the injectables and Novo outgrowing the broader GLP-1 market driven by oral sema.”