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Novartis (NVS) Presents Positive Data on Cardiovascular Drug


Novartis AG NVS announces new analysis from the PARADIGM-HF study on its cardiovascular drug, Entresto, at a scientific meeting of the Heart Failure Society of America.

Results from the study demonstrated the benefits of Entresto in heart failure patients with reduced ejection fraction (HFrEF). Patients on Entresto reported higher quality of life scores, compared to those taking ACE inhibitor, enalapril.

Note that Entresto (twice-daily) is used in conjunction with other heart failure therapies for reducing strain on the failing heart. It is indicated in the U.S. for the treatment of heart failure (NYHA class II-IV) in patients with systolic dysfunction. In the EU, the drug is approved for the treatment of symptomatic chronic HFrEF in adult patients.

Novartis is working on expanding Entresto’s label and is evaluating the drug for preserved ejection fraction heart failure conditions.

We remind investors that Entresto received a strong Class I recommendation in both the U.S. and the EU as per heart failure treatment guidelines. These guidelines establish Entresto as the standard of care for symptomatic patients with HFrEF. Drug sales are expected to be approximately $200 million in 2016.

Heart failure, a debilitating and life-threatening condition, affects over 60 million individuals across the world.



Meanwhile, the company has also announced positive top-line results from the phase III EXPAND study on its pipeline candidate, BAF312 (siponimod), for the treatment of secondary progressive multiple sclerosis (SPMS).

Results demonstrated that an oral once-daily BAF312 led to a 21% reduction in the risk of three-month confirmed disability progression, in comparison to placebo. The candidate was generally safe and well tolerated. Data were presented at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis.

Novartis said that it will complete full analyses of the data from the EXPAND study and determine the next steps in consultation with health authorities. Full study results will be submitted for publication.

MS, a chronic disorder, affects approximately 2.3 million individuals in the world. With very few treatment options to delay disease progression in SPMS, there is high unmet need for effective therapies with an acceptable safety profile.

Novartis’ MS portfolio currently includes Gilenya and Extavia. Meanwhile, the company’s MS pipeline comprises ofatumumab (OMB157), a fully human monoclonal antibody, in development for relapsing MS.

Going forward, investors should keep an eye on the approval of new drugs and label expansion of the existing ones at Novartis, given that the company has been facing stiff generic competition for some of its key drugs like Gleevec.

Novartis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Pacira Pharmaceuticals, Inc. PCRX, Corcept Therapeutics Incorporated CORT and ANI Pharmaceuticals, Inc. ANIP. All three stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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