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Novartis Announces Positive Results for Cardiovascular Drug

Novartis AGNVS announced positive top-line results from the global phase III study, CANTOS. The study evaluated the efficacy, safety and tolerability of ACZ885 (canakinumab) in combination with standard of care in patients with a prior heart attack and inflammatory atherosclerosis.

CANTOS is a randomized, double-blind, placebo-controlled, event-driven phase III study. It is designed to evaluate the efficacy, safety and tolerability of quarterly subcutaneous injections of canakinumab in combination with standard of care in the prevention of recurrent cardiovascular (CV) events. The study enrolled patients with a prior myocardial infarction (MI) and with a high-sensitivity C-reactive protein (hsCRP).

The study met the primary endpoint as the candidate demonstrated canakinumab when used in combination with standard of care reduced the risk of major adverse cardiovascular events (MACE). Novartis will present the full data later in 2017.

Approximately 580,000 people in the EU and 750,000 people in the U.S. are affected by heart attacks every year. Heart patients remain susceptible to a second attack and even death. 25% of heart attack survivors are estimated to experience another cardiovascular event within five years. Among four in 10 patients, the risk is directly related to increased inflammation associated with atherosclerosis thereby highlighting the great need for treatments like canakinumab.

The successful development and commercialization of canakinumab will significantly boost Novartis' cardiovascular portfolio. The company currently has Entresto in its portfolio which has been given a Class I recommendation in the U.S. and EU clinical guidelines for the treatment of heart failure with reduced ejection fraction (HFrEF).

We remind investors that canakinumab was first approved in 2009 for cryopyrin-associated periodic syndromes as Ilaris. In 2016, the FDA approved the label expansion of the drug to treat three rare and distinct types of periodic fever syndromes - tumor necrosis factor-receptor associated periodic syndrome, hyperimmunoglobulin D syndrome / mevalonate kinase deficiency and familial Mediterranean fever.

Novartis has outperformed the Zacks classified industry in the last six months. The stock has rallied 15.0% compared with the industry's gain of 13.7%.

Novartis has outperformed the Zacks classified industry in the last six months. The stock has rallied 15.0% compared with the Large Cap Pharmaceuticals industry's gain of 13.7%.

Going forward, we expect that the approval of new drugs and label expansion of existing ones will bode well for Novartis even though stiff generic competition for key drugs like Gleevec continues to act as a major deterrent. Earlier in the week,

Novartis announced that that its generic arm, Sandoz, has received European Commission (EC) approval for Rixathon, a biosimilar version of Roche's RHHBY MabThera in Europe. The FDA accepted Sandoz's Abbreviated New Drug Application (ANDA) for a generic version of GlaxoSmithKline's GSK asthma drug, Advair Diskus.

Zacks Rank

Novartis currently carries a Zacks Rank #3 (Hold). A better-ranked stock in healthcare sector include VIVUS, Inc. VVUS which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here .

VIVUS's loss per share estimates lessened from 50 cents to 39 cents for 2017 in the last 60 days. The company posted positive earnings surprises in all four trailing quarters with average beat of 233.69%

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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