Novo Nordisk (NVO - Free Report) announced positive headline results of two phase III studies PIONEER 4 comparing 14 mg oral formulation of Ozempic (semaglutide) as a treatment for adults with type II diabetes to Victoza1.8 mg and placebo and PIONEER 7 comparing oral formulation of Ozempicas a treatment for adults with type II diabetes to sitagliptin 100 mg.
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.
The 52 week PIONEER 4 study achieved its primary objective according to the primary statistical approach by demonstrating a non-inferior reduction in blood glucose levels (HbA1c) and statistically significant and superior weight loss at 26 weeks with oral Ozempic compared to Victoza.
Ozempic also provided statistically significant and superior reductions in HbA1c and weight compared to placebo. For week 26 and week 52, respectively, people treated with Ozempic experienced a reduction in HbA1cof 1.3% and 1.2% compared to 1.1% and 0.9% with Victoza whereas placebo declined 0.1% and increased 0.2%.
Ozempic also demonstrated weight loss of 4.7 kg at 26 weeks and 5 kg at 52 weeks versus 3.2 kg and 3.1 kg with Victoza, and 0.7 kg and 1.2 kg with placebo at 26 and 52 weeks respectively.The increased weight loss with oral Ozempic was also significant compared to Victoza and placebo.
The 52-week PIONEER 7 study also achieved its primary objective accordingto the primary statistical principle by demonstrating that people treated with oral semaglutide experienced a statistically significant reduction in HbA1cof 1.4% compared to 0.7% with sitagliptin at week 52. The reduction in body weight of 2.9 kg with oral semaglutide was statistically significantly greater at week 52 compared to 0.8 kg with sitagliptin.
Novo Nordisk plans to report the PIONEER 3 study comparing 3, 7 and 14 mg oral semaglutide with 100 mg sitagliptin before the end of second quarter of 2018.
Shares of the company have moved down 16.6% year to date compared with the industry’s decline of 4.4%.
We remind investors that in May 2018, Novo Nordisk announced headline results from PIONEER 2, the second phase IIIa study with oral formulation of Ozempic 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 - Free Report) 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 HbA1c with oral Ozempic compared to Jardiance at 26 weeks.
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 - Free Report) once-weekly Bydureon are competitors to Novo Nordisk’s Ozempic.
Zacks Rank & Stocks to Consider
Novo Nordisk has a Zacks Rank #5 (Strong Sell).
A better-ranked stock from the same space is Aeglea BioTherapeutics, Inc. (AGLE - Free Report) carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Aeglea’s loss per share estimates have narrowed from $1.93 to $1.67 for 2018 and from $3.86 to $3.57 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 19.32%. The stock has rallied 101.3% so far this year.
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