Novartis probably already has the data it needs for a regulatory approval of its big cardio drug canakinumab. Now it says it has the data in hand for a big piece of the market that payers won’t be able to turn their noses up at.
Using a simple biomarker test, Novartis’ $NVS development chief, and soon CEO, Vas Narasimhan says that the drug proved more clearly impactful for heart attack patients whose hsCRP level — a measure of inflammation using high-sensitivity C-reactive protein — fell below 2mg/L after three months of treatment. By that score, they tracked a 31% reduction in cardiovascular death and a 31% reduction in all-cause mortality.
Put another way, treating 16 people for 5 years would prevent one death, heart attack, stroke or coronary revascularization in the sub-group, compared to 24 patients for the entire population studied in the massive 10,000-patient trial that ran 6 years.
“We set out to identify a subgroup with higher efficacy,” Narasimhan told a group of reporters ahead of the release. And they found one where they believe their drug can demonstrate a higher value.
“Importantly, these data also support the value of targeting inflammation when treating patients who have had a heart attack in the past, reinforcing that ‘lower is better’ when it comes to levels of inflammation,” says Paul Ridker, the CANTOS study chairman and director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital.
The numbers are acutely important for Novartis, which would clearly like to avoid the experience of Regeneron/Sanofi and Amgen, which fielded big new cholesterol drugs for cardio patients only to find payers throwing up steep road blocks at every turn to prevent the reimbursement needed to make sales. Amgen in particular trumpeted significant cardio risk reduction for their therapy, only to see payers remain stubbornly opposed to it without clear evidence of a mortality benefit.
What Novartis is aiming for is a drug that can be used in tandem with a cholesterol therapy, and now it has to come up with a compelling enough economic argument in its favor to justify whatever price it has in mind.
Analysts are keenly aware of the challenges Novartis faces, especially after seeing the pharma giant struggle to gain market traction for Entresto and being forced to concede that its big blockbuster hopeful serelaxin was a flop. But they also appreciate the potential here.
The drug, sold as Ilaris for a niche market, is on track to earn $380 million this year. And considering data on an added risk of infection as well as some expert fretting about the somewhat fuzzy clarity of the benefit initially on display, Tim Anderson pegged the peak sales at a consensus of $800 million, while noting that patent protection should run out in only 7 years.
There is a side benefit to this drug that Novartis is still trying to puzzle out. The drug produced a reduction in lung cancer mortality of 77%, underscoring their theory that inhibiting IL-1ß could produce promising data in oncology.
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