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Novo Nordisk’s Tresiba Shows Safe Cardiovascular Profile


Novo Nordisk A/S NVO announced head-line results from the DEVOTE study on Tresiba, which confirmed the cardiovascular safety of the drug, in comparison to Sanofi’s SNY Lantus (insulin glargine U100), when added to the standard of care.

The study was conducted in patients (n>7,500) with type II diabetes who are at a high risk of major adverse cardiovascular events.

Data from the study demonstrated non-inferiority of major adverse cardiovascular events with Tresiba compared to Lantus, thereby meeting the primary endpoint. In addition, Tresiba demonstrated superiority on the secondary confirmatory endpoint, resulting in 27% fewer patients experiencing an episode of severe hypoglycemia. Moreover, patients on the Tresiba arm experienced a 54% relative reduction in the rate of nocturnal severe hypoglycemia.

Findings from the study confirmed data from the interim analysis of the DEVOTE study that were submitted to the FDA in Mar 2015 for the approval of Tresiba and Ryzodeg 70/30. The company plans to submit these findings to regulatory authorities during the first half of 2017.

Note that in Sep 2015, Tresiba and Ryzodeg 70/30 was approved in the U.S. for the treatment of diabetes mellitus in adults.

Novo Nordisk has a strong presence in the Diabetes Care market, supported by one of the broadest diabetes portfolios in the industry, which comprises drugs like Victoza, Levemir and modern insulins.

Meanwhile, the company’s once-daily, single-injection, fixed combination of Tresiba and Victoza, IDegLira, is currently under review in the U.S. for the treatment of adults with type II diabetes. A response from the FDA is expected in Dec 2016. A potential approval in the U.S. will significantly expand the company’s portfolio.

However, Novo Nordisk’s share price performance has dropped 8.2% in the past one month after it reported third-quarter results on Oct 28 and lowered its full-year sales guidance. The decline in share price was slightly wider than the 7.93% drop for the Zacks classified large cap-pharma market industry.



Zacks Rank & Key Picks

Novo Nordisk carries a Zacks Rank #4 (Sell). A couple of better-ranked stocks in the health care sector include Cambrex Corporation CBM and Vanda Pharmaceuticals, Inc. VNDA. Both stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 6.2% year to date.

Vanda’s loss estimates narrowed from 68 cents to 56 cents for 2016, while its earnings estimates increased from 16 cents to 17 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average positive surprise of 56.65%. Its share price has surged 85.8% year to date.

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