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 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.
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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)
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