Novartis team scores a pioneering first in cardio R&D. But can they sell it?

Novartis is facing another blockbuster challenge of global proportions.

How do you market a heart drug with real but clearly limited health benefits? One where there’s no established ability to seriously cut down the rate of death — and headed to a field where payers are skilled at standing between patients and high-cost PCSK9 drugs?

That’s the situation for Novartis as it takes its data on canakinumab to the FDA and regulators around the world.

The pharma giant’s achievement can’t be ignored. This is the first time an anti-inflammatory therapy was able “to demonstrate reduced risk of major cardiovascular events,” noted Novartis CMO Vas Narasimhan in a call with reporters ahead of their presentation at the European Society of Cardiology. And the company’s top researchers also hinted at one possible marketing strategy that might work best.

The key figure Novartis plucked out of the endpoints data: a 15% reduction among 10,000 patients in the risk of another major cardiovascular event like heart attack or stroke. There was a 10% “trend” toward a mortality benefit, which won’t impress payers who have been setting a high bar on cardio drugs, as Novartis already knows first hand as they have made slow progress in marketing Entresto.

One major highlight on the subgroup analysis, though, could hold a key to identifying a large patient population that could benefit more distinctly. Using their biomarker for high-sensitivity C-reactive protein, the half of patients who were under the median response three months after starting treatment in the CANTOS study had a 27% risk reduction for heart attack or stroke.

Patients were followed for a median of 3.7 years for this trial.

Canakinumab warranted blockbuster handling after demonstrating the potential of a drug that aimed directly at IL-1ß. The theory, which sparked considerable skepticism among analysts, was that if you reduced inflammation by hitting the target, patients would stand a better chance of going without another potentially lethal reaction to their heart disease.

Novartis already sells this drug as Ilaris for rare cases of juvenile arthritis at about $200,000 a year — list price — in the US. But that figure would have to be significantly chopped down for a broad patient population, given the Repatha headaches that Amgen has had with equally modest — but distinct — results for cutting LDL. Repatha lists at a little above $14,000 a year. Entresto’s price is set at about $4,500.

There are also some major unanswered questions that could take many months or even years to clarify.

“The modest absolute clinical benefit of canakinumab cannot justify its routine use in patients with previous myocardial infarction until we understand more about the efficacy and safety trade-offs and unless a price restructuring and formal cost-effectiveness evaluation supports it,” noted Stanford’s Robert Harrington in an accompanying editorial in the New England Journal of Medicine.

Advocates, though, were quick to applaud.

“It’s a gateway to a very wide variety of therapies that are going to be developed,” Cleveland Clinic’s Steven Nissen told Science. “This is as big as anything we’ve seen in a while.”

But is it big enough to sell?

Novartis, though, likes a big challenge, even after experiencing several ups and downs in the heart arena. And it bought into an even bigger challenge with new data to support the drug’s ability to reduce the risk of lung cancer.

One thing seems certain. Whatever happens to canakinumab, other developers will be looking to prove the longterm benefits of reducing inflammation. Look for more studies among the players who can fund this work, and the biotechs looking to make deals around Phase II.

Image: Novartis CMO Vas Narasimhan Getty

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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