Merck & Co., Inc. MRK and partner Pfizer Inc. PFE announced that its pipeline candidate, ertugliflozin, met primary endpoints in two late stage studies evaluating ertugliflozin in adults with Type 2 diabetes. The results were presented at the Scientific Sessions of the American Diabetes Association (ADA) in San Diego.
Marketing applications for ertugliflozin, one as a monotherapy and one each for fixed-dose combinations ertugliflozin/Januvia and ertugliflozin/metformin, are under review with the FDA and the European Medicines Agency. The FDA is expected to announce its decision in December this year.
Merck’s shares are up 9.4% so far this year, comparing unfavorably with an increase of 10.8% witnessed by the Zacks classified Large-Cap Pharma industry.
The two late stage studies – VERTIS MET and VERTIS SITA – evaluated the combination of ertugliflozin (5 mg and 15 mg daily) with metformin or Merck’s another diabetes drug, Januvia (100 mg), respectively. Both the studies compared efficacy and safety of the combination therapies with a placebo.
Data from the studies showed that ertugliflozin, when added to Januvia or metformin, led to A1C (a measure of average blood glucose) reduction in patients with type II diabetes. The drug met the key secondary endpoints of the studies as well. Overall adverse event (AE) rates were also low in both the dosage arms of ertugliflozin compared to placebo. Moreover, the candidate in both the studies achieved significant reductions in fasting plasma glucose (FPG), body weight, systolic blood pressure (SBP) and diastolic blood pressure (DBP), when compared with placebo.
Ertugliflozin is an oral sodium glucose cotransporter (SGLT2) inhibitor to help improve glycemic control in type 2 diabetes patients.
The companies are evaluating the candidate in nine phase III programs under the VERTIS program in adults with type 2 diabetes. This includes VERTIS CV study evaluating its non-inferiority to placebo in cardiovascular problems including death or nonfatal myocardial infarction or nonfatal stroke.
Merck’s diabetes franchise includes drugs like Januvia and Janumet (Januvia + metformin HCl). The franchise recorded sales of $1.3 billion in the first quarter of 2017, down 5% from the year-ago due to the timing of customer purchases in the U.S.
However, we note that the diabetes space is highly crowded with drugs like Eli Lilly & Company’s LLY Tradjenta and Jardiance and Novo Nordisk A/S’s NVO Victoza and Tresiba among others. Merck’s diabetes portfolio will get a boost after the approval of ertugliflozin therapies.
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Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Zacks Investment Research
June 12, 2017 at 06:21PM
from Zacks Equity Research
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