Novartis to showcase heart failure leadership at ESC Congress 2014 with results on new first of its type medicine LCZ696

Novartis International AG / Novartis to showcase heart failure leadership at ESC Congress 2014 with results on new first of its type medicine LCZ696 . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• LCZ696 significantly reduced cardiovascular deaths in head to head study against enalapril, in addition to current best treatment, in patients with HF-REF

• PARADIGM-HF is the largest heart failure study ever conducted - stopped early in March 2014 due to compelling efficacy[1],[2]

• LCZ696 recently granted FDA Fast Track status  - rolling submission expected to be complete by end of year

Basel, August 11, 2014 - New data revealing the reduction in cardiovascular (CV) deaths with Novartis' LCZ696 in patients with heart failure with reduced ejection fraction (HF-REF) will be presented at the world's largest cardiology congress, the European Society of Cardiology (ESC) Congress 2014, on Sunday August 31^st at 08.30 CET. The data will also be highlighted in the official ESC press conference on Saturday August 30^th at 13.00 CET. The study met the primary endpoint showing LCZ696 reduced heart failure hospitalizations along with CV deaths.

The 8,442 patient study, PARADIGM-HF, was specifically designed to see if LCZ696 could increase survival over and above what can be achieved with ACE-inhibitor enalapril in addition to current best treatment in HF-REF patients[1]. In March 2014 the Data Monitoring Committee overseeing the study confirmed those given LCZ696 were significantly less likely to die from CV causes, leading to the trial being closed early.

Over 26 million people worldwide live with heart failure, facing a high risk of death and poor quality of life, despite currently available medicines[3],[4],[5]. As a serious condition with an urgent need for new treatments, the FDA has granted LCZ696 Fast Track designation, which can expedite the review of new medicines intended to treat serious or life-threatening conditions. Fast Track designation also allows for rolling submission in the US, which Novartis expects to complete by the end of 2014.

The scientific presentation at the ESC Congress 2014 will include safety data from the study showing LCZ696 was well-tolerated and side effects manageable. 10 further presentations throughout ESC Congress 2014 will provide a wider overview of Novartis's ongoing research in heart failure and other areas of cardiology.

Novartis presentations on LCZ696 at ESC include:

• 7 abstracts (2 oral presentations and 5 posters):
  • Results of the Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF) (#881), M Packer - Hot Line: Cardiovascular disease: novel therapies - Sunday August 31st, 08:30 - 10:20 (08:30-08:45)
  • Results of the Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF) (#1115), J McMurray, M Packer - Meet the Trialist I: PARADIGM-HF - Sunday August 31st, 10:10 - 10:50 (10:10)
  • High prevalence of elevated high sensitivity troponin-T and reduction in levels by LCZ696 in heart failure with preserved ejection fraction in the PARAMOUNT trial (#P5847), P S Jhund - Moderated Posters: Defining prognosis in heart failure with preserved ejection fraction - Tuesday September 2nd,  15:30 - 16:30 (15:55)

About LCZ696