Novo Nordisk NVO announced headline results from PIONEER 2, the second phase IIIa study with oral formulation of Ozempic (semaglutide) for treatment of adults with type II diabetes. The study evaluated the efficacy and safety of 14 mg oral Ozempic compared with 25 mg Eli Lilly LLY and Boehringer Ingelheim's Jardiance (empagliflozin) with type II diabetes inadequately controlled on metformin.
The 52 week study achieved its primary objective and demonstrated a statistically significant and superior improvement in blood glucose levels (HbA1c) with oral Ozempic compared to Jardiance at 26 weeks. The study showed a statistically significant improvement in HbA1c of 1.4% at 26 weeks and 1.3% at 52 weeks, compared to an improvement in HbA1c of 0.9% and 0.8% with 25 mg empagliflozin at 26 and 52 weeks, respectively
Ozempic also demonstrated weight loss of 4.2 kg at 26 weeks and 4.7 kg at 52 weeks versus 3.8 kg with 25 mg Jardiance at both 26 weeks and 52 weeks. The increased weight loss with oral Ozempic was also significant compared to Jardiance at the 52-week time point.
We remind investors that in December 2017, the FDA approved Ozempic once-daily pre-filled pen to improve glycaemic control in type II diabetes patients. It is also approved in Europe, Japan and Canda for the same indication.
Shares of Novo Nordisk have decreased 12.8% compared with the industry 's decline of 6%.
In February 2018, Novo Nordisk successfully completed the first phase IIIa trial, PIONEER 1, with oral Ozempic for treatment of adults with type II diabetes. The trial achieved its primary objective by demonstrating statistically significant and superior improvements in blood glucose levels (HbA1c) for all three doses of oral Ozempic compared to placebo.
By mid-2018, the company plans to initiate a cardiovascular outcomes study called SOUL for Ozempic. Also the company plans to initiate a phase IIIa program called STEP in 2018 to explore the potential of once-weekly Ozempic as a treatment for people with obesity. This will also include the cardiovascular outcomes trial, SELECT, which will investigate the impact of Ozempic on the incidence of major adverse cardiovascular events compared to placebo in patients with established cardiovascular disease and either overweight or obesity.
In GLP-1 market, Lilly's Trulicity and AstraZeneca's AZN once-weekly Bydureon are competitors to Novo Nordisk's Ozempic.
Zacks Rank & Stocks to Consider
Novo Nordisk has a Zacks Rank #3 (Hold).
A better-ranked stocks from the same space is Illumina, Inc. ILMN , sporting a Zacks Rank#1 (Strong Buy).You can see the complete list of today's Zacks #1 Rank stocks here .
Illumina's earnings per share estimates have moved up from $4.83 to $4.86 for 2018 and from $5.57 to $5.60 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 23.17%. The stock has rallied 21.9% so far this year.
Novo Nordisk A/S Price
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