Novartis chases new canakinumab niche after overall data failed to excite

Novartis is hoping it can expand its canakinumab, currently approved as Ilaris for certain rare disease, into a mass-market CV drug.

Novartis in August published findings from the phase 3 Cantos trial of Ilaris that weren't "fully compelling to payers," the company's CEO-to-be, Vas Narasimhan, said on a Monday conference call. Now, Novartis is back with subgroup data for the proposed cardiovascular drug it thinks are more promising. 

After digging into the results further, the Swiss drug giant on Monday released subgroup data for certain study patients who experienced a larger benefit than the overall group. Cantos examined canakinumab—already approved as Ilaris for certain rare diseases—in patients who have had a prior heart attack and inflammatory atherosclerosis as measured by high-sensitivity C-reactive protein (hsCRP) levels.  

For patients whose hsCRP levels were below 2 milligrams per liter three months after receiving the drug, canakinumab was associated with a 25% risk reduction in major adverse cardiovascular events, plus a 31% reduction in cardiovascular deaths and all-cause mortality. 

"Overall, I think these results suggest a simple test at three months can identify the patients who would benefit most, and that in general, lower (hsCRP) is better," Narasimhan said on the call Monday. "When you get down to 1.5 (mg/L) you see even more benefit than if you were at the threshold of 2 (mg/L)." 

The company says about 55% of Cantos patients were included in the subgroup. 

In August, Novartis released overall phase 3 Cantos data showing its med reduced the risk for major cardiovascular events by 15% and cardiovascular death by 10%. As Narasimhan put it on the call Monday, the figures likely weren't "fully compelling to payers." 

Currently marketed for orphan indications, Ilaris carries a price per vial of more than $16,000, according to GoodRx, but that figure wouldn't fly for a mass-market CV med. New PCSK9 meds from Amgen and Sanofi run around $14,000 per year before discounts, but cost watchdogs have said even those prices are too high to justify.  

With the subgroup data in hand, Novartis is prepping for regulatory filings by the end of the year for its proposed CV drug. However, in order for the company to effectively launch and price the med in a completely new use, language about the hsBRC levels has to be in the label, Narasimhan said. 

Bernstein analyst Tim Anderson wrote in a note that there are a lot of uncertainties around a potential CV nod for the drug, including commercial prospects, whether the FDA would grant the necessary label and how payers would react. Importantly, he noted, the drug loses patent protections in 2024 and his team predicts the chances Novartis can win an IP extension aren't great.

According to a note from Leerink analyst Seamus Fernandez, Novartis on Monday "reiterated its plans to provide the first dose for free in order to determine who responds, but would not provide any clarity on how the drug’s price might change following an approval in this indication." 

The subgroup analysis was published in the journal Lancet. Currently the company's development head, Narasimhan is starting as Novartis' CEO in February, succeeding current helmsman Joe Jimenez.