Novo Nordisk's Onset 1 & Onset 2 Meet Primary Objectives - Analyst Blog
Novo Nordisk A/S NVO 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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