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Novartis Presents Data on Heart Failure Candidate LCZ696

Novartis (NVS) announced new data on pipeline candidate, LCZ696, from the phase III study, PARADIGM-HF.

Data from the randomized, double-blind study showed that LCZ696 reduces the occurrence of sudden deaths, emergency room visits, hospitalizations, deteriorating symptoms and the need for more intense treatment in patients with heart failure with reduced ejection fraction as compared to enalapril.

This data was presented at the American Heart Association Scientific Sessions 2014.

Novartis plans to file for marketing authorization for LCZ696 with FDA by the end of 2014 and with the European Medicines Agency by early 2015.

Last week, Novartis announced positive results from phase III results – FUTURE 1 and FUTURE 2 on pipeline candidate secukinumab (AIN457), a selective interleukin-17A (IL-17A) inhibitor.

Results from the studies showed that secukinumab showed rapid and significant clinical improvements versus placebo in improving the signs and symptoms of psoriatic arthritis (PsA).

The FUTURE 1 study showed that more than 80% of patients treated with secukinumab experienced no progression of joint structural damage, which affects two-thirds of PsA patients.The results were presented at the American College of Rheumatology (:ACR) Congress in Boston.

We note that Novartis is also evaluating secukinumab for the treatment of ankylosing spondylitis (:AS) and rheumatoid arthritis (RA.V). Novartis has also announced positive results from the phase III studies, MEASURE 1 and MEASURE 2 on secukinumab in AS. Secukinumab met the primary endpoint in both the studies and demonstrated rapid and statistically significant improvements versus placebo in the signs and symptoms of AS.

Novartis plans to make global regulatory submissions on secukinumab for the treatment of PsA and AS in 2015. Meanwhile, the FDA’s response regarding secukinumab’s approval status for moderate-to-severe plaque psoriasis should be out in early 2015. Novartis has also filed for the approval of secukinumab in the EU where a response should be out by the end of 2014 or early 2015.

Our Take

Successful development and commercialization of secukinumab for the treatment of psoriasis will further strengthen Novartis’ dermatology portfolio. The company already has Xolair in its dermatology portfolio which is approved for the treatment of refractory chronic spontaneous urticaria in the EU and is known as refractory chronic idiopathic urticaria in the U.S.

Novartis currently needs to focus on its pipeline as it faces generic competition for several key drugs such as Gleevec, Zometa and Diovan.

Novartis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader health care sector include AbbVie (ABBV), Allergan (AGN) and Bristol-Myers Squibb (BMY). All three carry a Zacks Rank #2 (Buy).

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