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New Novartis Heart Drug Seen to Have Enormous Potential

03.09.2014 -

A new experimental heart failure medication developed by Swiss drugmaker Novartis with the working name of LCZ696 is being widely regarded as having potential to significantly reduce the number of deaths and hospitalizations caused by cardiovascular disease.

For the company it could provide more than a shot in the arm, as analysts are now forecasting peak sales of $5 billion or more.

Novartis plans to file for approval of the drug in the US by the end of 2014 and in Europe in the first quarter of 2015. The company had Novartis announced in March that trials were being ended early because the drug had been better than the comparator drug.

The new cardiovascular treatment was tested on 8,442 heart failure patients as part of the Novartis-sponsored Paradigm-HF study. Patients received either LCZ696 or the ACE inhibitor enalapril, along with current treatment options.

Patients who received LCZ696, the study showed, were able to reduce their risk of cardiovascular death by 21% and hospitalization due to heart failure by 16% compared with those who received enalapril.

The research was published Aug. 30 in the New England Journal of Medicine and presented at the European Society of Cardiology's annual meeting in Barcelona on Aug. 31.

By demonstrating a very significant reduction in cardiovascular deaths while improving quality of life, the new heart medicine represents one of the most important cardiology advances of the last decade, David Epstein, division head of Novartis Pharmaceuticals told the conference.

LCZ696 combines the angiotensin receptor blocker valsartan, the blockbuster heart drug that Novartis sells as Diovan - now off-patent - with a drug called sacubitril. The first in a new class of therapies blocks neprilysin, an enzyme that breaks down a hormone needed for decreasing blood pressure. This takes the load off the heart and allows the kidneys to function more normally, Epstein explained.  

The drug may well represent a new threshold of hope for patients with heart failure, Mariell Jessup, president of the American Heart Association, wrote in an editorial accompanying the study.              

Analyst forecasts for LCZ696 have been climbing in recent months and the most recent consensus for sales in 2019 - four years after its expected launch - stood at $1.9 billion shortly before the announcement in Barcelona, according to Thomson Reuters Cortellis. That number now looks out of date