PARADIGM-HF trial of Novartis' LCZ696 for chronic heart failure closes early based on strength of interim results

Novartis International AG / PARADIGM-HF trial of Novartis' LCZ696 for chronic heart failure closes early based on strength of interim results . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Data Monitoring Committee (DMC) unanimously recommends early closure confirming combined primary endpoint met - LCZ696  delayed cardiovascular death and reduced heart failure hospitalizations vs. enalapril

PARADIGM-HF is the largest ever trial of a heart failure treatment, robustly designed to assess LCZ696 in patients with chronic heart failure with reduced ejection fraction[1],[2]

Over 20 million people across the US and EU live with chronic heart failure, facing a high risk of death and poor quality of life, despite currently available medicines[3],[4],[5]

Basel, March 31, 2014 - Novartis announced today that the Data Monitoring Committee (DMC) unanimously recommended early closure of the PARADIGM-HF study, indicating patients with chronic heart failure with reduced ejection fraction (HF-REF) who received LCZ696 lived longer without being hospitalized for heart failure than those who received standard care with ACE-inhibitor enalapril. Based on the compelling efficacy and primary endpoint having been met, the trial will now close early. This follows two previous interim analyses that showed the safety profile of LCZ696 was acceptable.

"Novartis recognizes the huge global need for treatments that extend and improve the lives of people with heart failure and we believe LCZ696's unique mechanism of action could be transformative," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. "This result is a demonstration of our commitment to developing innovative medicines that have an impact on the most important outcomes like cardiovascular mortality."

The results of PARADIGM-HF will be submitted to a major medical conference for presentation and Novartis will now initiate discussions with global health authorities regarding approval for marketing.

"The results of PARADIGM-HF are truly impressive" said Dr. Milton Packer, Professor and Chair for the Department of Clinical Sciences at University of Texas Southwestern Medical Center, Texas, USA and one of the two Principal Investigators. "The finding that treatment with LCZ696 was superior to currently recommended doses of enalapril has profound implications for the care of patients with chronic heart failure. We now have compelling evidence that supports LCZ696 as a new cornerstone in the management of chronic heart failure."