PARADIGM-HF trial of Novartis' LCZ696 for chronic heart failure closes early based on strength of interim results - Seite 2

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[2],[6],[7]. 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[2],[7].

LCZ696 is the second treatment being developed by Novartis for patients with heart failure, along with RLX030 (serelaxin) for acute heart failure[8].

About the PARADIGM-HF study
PARADIGM-HF is a randomized, double-blind, Phase III outcome study evaluating the efficacy and safety profile of LCZ696 versus enalapril (a widely used ACE inhibitor) in 8,436 patients with heart failure with reduced ejection fraction (HF-REF)[1],[2]. The primary outcome is a composite of time to first occurrence of either cardiovascular death or heart failure hospitalization, and the trial is also designed to be able to detect a significant difference in cardiovascular death[1],[2]. The study was initiated in December 2009 and currently is the largest clinical trial in heart failure ever undertaken[1],[2].

About chronic heart failure
Chronic heart failure is a progressive, debilitating disease where the heart is unable to pump enough blood throughout the body. Symptoms such as breathlessness, fatigue and fluid retention can appear slowly and worsen over time, significantly impacting quality of life[4],[9]. Approximately half of patients have the reduced ejection fraction form of the disease (HF-REF)[10].

Heart failure is a significant and growing public health concern with more 20 million people living with the disease across Europe and the US alone[3],[4],[5]. It continues to be associated with high morbidity and mortality, frequent hospitalization and poor quality of life, despite currently available medicines[11],[12]. Heart failure presents a major and growing health-economic burden that currently exceeds $45 billion worldwide[13],[14],[15],[16]. As such, there is a high unmet need for new treatments that reduce cardiovascular mortality and the frequency of hospitalization.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "recommends," "indicating," "risk," "recommended," "believe," "could," "commitment," "will," "implications," "supports," "thought," "designed," "growing," "continues," or similar terms, or by express or implied discussions regarding potential marketing approvals for LCZ696, or regarding potential future revenues from LCZ696. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that LCZ696 will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that LCZ696 will be commercially successful in the future. In particular, management's expectations regarding LCZ696 could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.