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Novo Nordisk's Onset 1 & Onset 2 Meet Primary Objectives - Analyst Blog

Novo Nordisk A/SNVO announced headline results from two final phase IIIa studies (onset 1 and onset 2) on faster-acting insulin aspart conducted under the phase III onset program.

Onset 1 investigated the efficacy and safety of faster-acting insulin aspart as compared to NovoRapid, both in combination with Levemir in patients suffering from type I diabetes, while onset 2 evaluated the efficacy and safety of faster-acting insulin aspart versus NovoRapid, both in combination with insulin glargine in type II diabetes patients. Results from both studies showed that faster-acting insulin aspart is non-inferior to NovoRapid in terms of lowering HbA1c levels, which helped to meet the primary study objectives.

Moreover, treatment with faster-acting insulin aspart was associated with lower increase in postprandial glucose than NovoRapid during meal tests in both studies. Faster-acting insulin aspart and NovoRapid were both safe and well tolerated among the patients.

Based on these results, Novo Nordisk stated that faster-acting insulin aspart (as shown by the onset 1 study) can potentially offer either an additional reduction of HbA1c or added flexibility compared to NovoRapid. Novo Nordisk intends to submit a marketing application for faster-acting insulin aspart in the U.S. and the EU by 2015-end or early 2016.

We note that NovoRapid, which lost patent protection in the U.S. in Dec 2014, generated revenues of DKK17.4 million in 2014.

Novo Nordisk carries a Zacks Rank #2 (Buy). Other well-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. ANIP , Cytokinetics, Inc. CYTK and Horizon Pharma plc HZNP . All these stocks carry a Zacks Rank #1 (Strong Buy).

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NOVO-NORDISK AS (NVO): Free Stock Analysis Report

HORIZON PHARMA (HZNP): Free Stock Analysis Report

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ANI PHARMACEUT (ANIP): Free Stock Analysis Report

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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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