On Monday, Novartis said that its heart failure drug Entresto failed a clinical trial, questioning billions of dollars in potential revenue.
The Swiss pharma company said in a statement, “The drug, already approved for reduced fraction heart failure, “narrowly missed” its objectives when tested on patients with preserved ejection fraction type of heart disease which affects 13 million globally, roughly half of all heart failure patients.”
Novartis added, “Twice-a-day Entresto has the potential for more than $3 billion annual sales for the current indication in patients whose heart muscles do not contract effectively.”
The company saw total annual sales increasing up to $5 billion with Entresto, a medicine for heart failure patients. The failure in this clinical trial conducted on 4,822 patients has put the increased sales at risk.
Novartis said, “The trial narrowly missed statistical significance for its composite primary endpoint of reducing cardiovascular death and total heart failure hospitalizations.”
The trial compared Entresto against the older medication called valsartan, which is sold under the brand name Diovan by Novartis.
Entresto got the approval in 2015, which started out slow, but has recently picked up momentum. The revenue increased about 80 percent in the first half of 2019 to $778 million globally.
Novartis would present the result of the trial at the European Society of Cardiology in September. It will discuss next steps with medical experts and drug regulatory bodies.
The likelihood of a positive outcome of the trial had been low, said analyst Michael Nawrath at Zuercher Kantonalbank. Currently, there are no approved treatments for preserved ejection fraction heart failure.
Nawrath said, “The milder the disease the higher the hurdle. It would have been very good for the momentum of Novartis, whose shares would have passed the 100 franc per share mark, on a positive outcome.” “Despite the relatively low expectations, we are talking about a negative but not sustained price reaction,” added the analyst.
