Novartis’ big PhIII for canakinumab scores a surprise win helping heart attack patients

Novartis buildings in Basel, Switzerland, as seen from Dreirosenbruecke bridge

With its new heart drug Entresto struggling to find traction and its top late-stage effort for serelaxin a flop, Novartis today may have finally turned things around with the big Phase III win in cardio it’s been searching for.

The pharma giant’s canakinumab (ACZ885) significantly reduced the risk of a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke for patients with a prior heart attack and inflammatory atherosclerosis. The pharma giant is sticking with top line data for now, but with analysts skeptical that the 6-year, 10,000-plus patient study would come through, Novartis saw its shares jump more than 2% Thursday morning.

This drug works by inhibiting IL-1ß, a key cytokine, for a prolonged period, tamping down on inflammation to lower risk to patients.

Investigators say they’ll now take the data to regulators in search of a marketing OK. The drug is currently approved for rare autoimmune diseases and sold as Ilaris.

Vasant Narasimhan

Novartis’ R&D team has invested heavily on heart failure drugs in recent years, determined to field blockbuster meds in cardio. But this is one of the toughest fields in drug R&D, with regulators looking for big data sets and payers skeptical of seeing value in expensive new drugs.

The devil now will be in the details about the data.

Leerink’s Seamus Fernandez wasted no time in picking up on Novartis’ challenge. He notes:

While this comes as a positive upside surprise to us, we await full data from the trial (expected at an upcoming medical meeting) to assess the magnitude of benefit and the results from key secondary endpoints before incorporating this indication into our model. In the wake of the muted launches of PCSK9 antibodies and recent cuts to reimbursement from NICE due to a lack of benefit on CV death in Repatha’s FOURIER study, together with evidence of CV benefits with two diabetes medications and the muted launch of Entresto despite a transformational outcome in the PARADIGM study, we believe commercial success likely will require an outsized benefit on CV death in a subset of these patients.

You’ll find the Regeneron $REGN team on the sidelines rooting for a blockbuster success here. The biotech detailed its royalty agreement with Novartis on the antibody this morning, noting that the deal starts with a 4% share that rises to 15% once revenue breaks the $1.5 billion mark.

Despite the serelaxin setback, Novartis’ R&D has been enjoying several successes this year, including the recent head-to-head matchup with Eylea, a positive data update on Cosentyx and a leading role pioneering CAR-T.

“Despite current treatment, about 25 percent of heart attack survivors will have another cardiovascular event within five years, making the outcome of the CANTOS study a promising new development for patients,” said Vas Narasimhan, the global head of drug development and CMO at Novartis. “ACZ885 is the first and only investigational agent which has shown that selectively targeting inflammation reduces cardiovascular risk. Our priority now is to thoroughly analyze these important data and discuss them with regulatory agencies.”

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