ZURICH Novartis's heart failure drug Entresto will be subjected to a battery of new trials as the Swiss drugmaker seeks to boost the medicine after a disappointing introduction.
Novartis, which on Thursday described the trials as "the largest global clinical program" for heart failure, is seeking among other things to assuage doctors' concerns over switching patients to Entresto when they are stable on older medicines.
Such worries, on top of insurers' reluctance to pay, have contributed to Entresto's lackluster start since its 2015 approval. Novartis now expects $200 million in 2016 sales, well behind analysts' initial forecasts.
"These trials will increase our understanding of heartfailure, the patient population who may benefit from Entresto, and could potentially support applications to regulatory authorities," said Vas Narasimhan, Novartis' chief medical officer.
The new program, called "Fortifying Heart Failure Clinical Evidence and Patient Quality of Life" or "FortiHFy", will include 40-plus trials in 50 countries over five years.
Entresto's stuttering launch was overseen by Novartis pharma chief David Epstein, who quit this week.
Recent heart drugs have gotten off to sluggish starts, partly due to fears their cost - about $4,500 a year for Entresto - could lead patients to quit medications.
Novartis forged deals with insurers Cigna and Aetna to be reimbursed based on "health outcomes" in a bid to overcome price concerns.
Chief Executive Joe Jimenez, who has stuck to his peak annual Entresto sales forecast of $5 billion, has also complained some physicians are slow to switch patients who are stable on existing medicines including enalapril, a 30-year-old drug.
Jimenez is keen for new trials to bolster evidence that patients can be switched safely; that patients can start on Entresto before taking other drugs; and to reveal more information about outcomes for those who switch to Entresto while in hospital.
Trials are also aimed at expanding Entresto's treatment label to additional kinds of heart failure and for patients after a heart attack.
Analysts said Novartis' plan showed its determination to convince investors it is doing everything possible to accelerate sales and reassure doctors.
"It's likely extra-large", said Stefan Schneider, from Bank Vontobel in Zurich, of the program's scope. "We assume a more extensive umbrella program is planned than if the existing clinical data would have sold the drug by itself."
Novartis did not release FortiHFy's cost.
Future trials will also include "much more U.S. physician participation," Novartis has said. Seven percent of patients were American in earlier trials, short of the 10-12 percent average and something analysts have flagged as one reason U.S. doctors have not rushed to prescribe.
(Reporting by John Miller; Editing by Mark Potter)