An unexpected win for Novartis’s Ilaris in cardiovascular disease could turn a niche drug into a blockbuster. The product is currently expected to bring in $549m in 2022, according to EvaluatePharma sellside consensus, but much of this comes from its approved rare disease indications, and many analysts had factored in a low probability of success in the Cantos trial.
These forecasts now look set to rise – Berenberg analysts, who had only given Cantos a 10% chance of reading out positive, have predicted revenues of $4.4bn if the cardiovascular indication is approved. This would make Ilaris Novartis’s second-biggest product in 2022, above Entresto (see table).
|Novartis's top 10 products in 2022|
|Entresto||Angiotensin II antagonists||Marketed||170||3,963|
|Sandostatin LAR Depot||Pituitary & hypothalamic hormones||Marketed||1,646||1,636|
Novartis is not saying much about Cantos except that the study met its primary endpoint, time to the first major adverse cardiovascular event – a composite of cardiovascular death, non-fatal myocardial infarction, and stroke – in patients with inflammatory atherosclerosis who had previously suffered a heart attack. Ilaris was given on top of standard of care.
Big benefit needed
Investors are likely to be cautious until the full magnitude of Ilaris’s benefit is revealed, possibly at the American Heart Association meeting in November – particularly after the recent disappointment with Amgen’s cholesterol-lowering drug Repatha, whose 15% benefit was not as impressive as had been hoped (ACC – No Repatha of glory, March 17, 2017).
Ilaris will probably have to do better, according to Leerink analysts, who wrote that only an “outsized benefit” on cardiovascular death would make the product a commercial success.
But for now Novartis will be breathing a sigh of relief that its 10,000-patient, six-year gamble has paid off – and put its cardiovascular strategy back on firmer ground after the miss earlier this year with serelaxin (Serelaxin setback puts focus on Entresto, March 22, 2017). Novartis’s share price was up as much as 4% today.
Regeneron, which was originally developing Ilaris, also looks set to benefit from the Cantos result. The company is due royalties of between 4 and 15%, with the highest rate triggered when sales exceed $1.5bn.
While Ilaris still has hurdles to clear, the Cantos win goes some way to validating the theory that targeting inflammation has an impact on cardiovascular risk – the asset inhibits IL-1β, a key cytokine in the inflammatory pathway.
Its novel mechanism also means that Ilaris could be given on top of statins and should not be threatened by generic versions of the cholesterol-lowering drugs.
But Ilaris’s cost could still be a sticking point. The product is priced at around $200,000 per year in its currently approved indications, Bernstein analysts estimate, where it is dosed monthly. In Cantos, Ilaris was given quarterly at three different doses: 50mg, 150mg and 300mg. It is not yet clear which dose or doses succeeded, which could have a bearing on its eventual price in cardiovascular disease, assuming it gets approved.
Other new cardiovascular drugs have struggled to find favour with payers, notably the PCSK9 inhibitors Repatha and Praluent, whose value for money has been questioned. Novartis would be advised to tread carefully with Ilaris. If it wants to charge a premium it needs an emphatic victory in Cantos.