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Phase III Data on Novartis' RLX030

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Switzerland-based pharmaceutical company, Novartis AG (NVS - Free Report) recently announced phase III data on its pipeline candidate, RLX030 (serelaxin), from the six month, RELAX-AHF study.

The study showed that treatment with RLX030 reduced the rate of mortality in patients suffering from acute heart failure (AHF), which has a higher death rate compared to other cardiovascular diseases.

The phase III RELAX-AHF study had two primary objectives which used different scales for measuring the reduction in dyspnea. The study managed to achieve one of the primary objectives. The study also revealed that RLX030 was well tolerated in patients.

The randomized, double-blind study, RELAX-AHF was conducted in 1,161 patients in 11 countries. The study evaluated the safety and efficacy of the candidate, RLX030, in the AHF indication versus placebo.

RLX030 along with loop diuretics and other medicines was administered to patients for up to 48 hours following hospitalization.

Novartis intends to discuss the results from the study with regulatory authorities around the globe. Data from the study will also be presented at the American Heart Association congress in November 2012.

Already approved heart failure treatments include AstraZeneca’s (AZN - Free Report) Toprol XL and Merck & Co.’s (MRK - Free Report) Prinvil.

We remind investors that in August 2012, Novartis had reported positive phase II data on its pipeline candidate, LCZ696, from the PARAMOUNT study for the treatment of chronic heart failure.

The study showed significant reduction in a key indicator of morbidity and mortality in patients suffering from chronic heart failure with preserved ejection fraction (HF-PEF).

Our Recommendation

Currently, we have a Neutral recommendation on Novartis. Novartis carries a Zacks #3 Rank (Hold rating) in the short run.

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