By J.J. McGrath - Novartis AG’s NYSE:NVS combination heart-failure drug LCZ696 made pulses race Saturday as the company released the final results of its comparative Paradigm-HF clinical trial. The data showed the medication in relation to the ACE-inhibitor enalapril cut the risk of death from cardiovascular causes by 20 percent and from all causes by 16 percent. The pill also reduced hospitalizations due to heart failure by 21 percent.
The major drug manufacturer disclosed its big news at the European Society of Cardiology congress in Barcelona, Spain, in the New England Journal of Medicine and on its own site. Based in Basel, Switzerland, it is among the top five pharmaceutical firms in the world ranked by annual revenue.
“By demonstrating a very significant reduction in cardiovascular deaths while improving quality of life, Novartis’ new heart-failure medicine, LCZ696, represents one of the most important cardiology advances of the last decade,” David Epstein, the head of the company’s Novartis Pharmaceuticals unit, said in a statement. Elaborating in an interview in Spain, Epstein told Reuters, “This result is better than we ever could have anticipated.”
Novartis announced in March the early closing of its Paradigm-HF clinical trial at the recommendation of the data monitoring committee overseeing it. Such committees historically have made these kinds of recommendations because the drugs being tested are performing either very well or very not well. In this case, LCZ696 met the primary endpoint for efficacy in its interim analysis, as the company detailed at the time, and met it with room to spare, as the firm detailed Saturday.
In March, Novartis described its investigational heart-failure medication this way:
LCZ696, a twice-a-day pill for heart failure, is a first-in-class medicine that acts in multiple ways on the neurohormonal systems of the heart, blocking receptors exerting harmful effects while simultaneously promoting protective mechanisms. Known as an ARNI (angiotensin receptor neprilysin inhibitor) LCZ696 is thought to reduce the strain on the failing heart, promoting the ability of the heart muscle to recover.
Analysis of the Paradigm-HF clinical-trial safety data showed LCZ696 side effects were manageable, Novartis said, so the company plans to file applications for marketing authorization with the U.S. Food and Drug Administration this year and with the European Union next year.
The analyst consensus forecast for LCZ696 sales in 2019, four years after its anticipated launch, is $1.9 billion, according to Thomson Reuters Cortellis. However, Deutsche Bank analysts have predicted the drug could eventually sell as much as $10 billion a year under certain conditions, Reuters reported.
Novartis’s share price in New York closed Friday at $89.84, as it advanced 11 cents, or 0.12 percent.