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Merck (MRK) Presents New Data from Januvia Diabetes Studies

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Merck & Co., Inc (MRK - Free Report) presented new data from two studies, evaluating its type II diabetes drug Januvia (sitagliptin) as a treatment option on type II diabetes patients, who initiate insulin therapy and those with a mild renal impairment.

The CompoSIT-I study showed higher reduction of blood glucose level in patients, who initiated insulin dosage while continuing treatment with Januvia compared with those who discontinued Januvia. The CompoSIT-R trial evaluated subjects with mild renal impairment, who were not adequately controlled by metformin. Data from this study showed that treatment with Januvia resulted in non-inferiority and superiority in reducing blood glucose levels (A1C) as compared to patients, treated with AstraZeneca’s (AZN - Free Report) Farxiga (dapagliflozin).

These data were presented at the American Diabetes Association meeting in Orlando, FL.

Shares of Merck have gained 8.4% year to date versus the industry’s decline of 4.4%


Combined sales of Januvia and Janumet declined 3% in 2017 due to ongoing pricing pressure. Merck’s Januvia franchise is facing pricing pressure due to higher discounts and rebates to maintain good managed care coverage. In the first quarter of 2018, sales of Januvia/Janumet rose 7% to $1.4 billion.

Last April, the FDA denied an approval to include cardiovascular outcomes on the labels of Januvia and Janumet. With death toll from cardiovascular disease being significantly higher among adults suffering diabetes in comparison to those without it, the addition of positive cardiovascular findings would have helped drive sales of these drugs. Moreover, with Eli Lilly (LLY - Free Report) and Boehringer Ingelheim including the cardiovascular indication on the label of their SGLT-2 inhibitor, Jardiance, DPP-IV inhibitors like Januvia could see patients switching to SGLT-2 inhibitors.

The latest addition to Merck’s diabetes franchise is Steglatro/ertugliflozin, approved as a monotherapy as well as two fixed-dose combinations with metformin and with Januvia in the United States last December and in the EU, this March. It is important to note that Merck markets Steglatro in a partnership with Pfizer, Inc. (PFE).

Merck currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is H Lundbeck A/S (HLUYY - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here

H Lundbeck’s earnings estimates have been revised 11.6% upward for 2018 and 4.3% for 2019 in the past 60 days. The stock has soared 44% year to date.

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