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Merck: Should Investors Be Interested in 2017?

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Part 7
Merck: Should Investors Be Interested in 2017? PART 7 OF 7

Merck Expects Solid Growth Trends for Cardio-Metabolic Franchise

Cardio-metabolic franchise

Merck’s (MRK) leading diabetes drug, Januvia, accounts for a 65% share of the global Dipeptidyl peptidase-4 (or DPP-4) inhibitor market, while the drug has 70% DPP-4 segment share in the United States.

Merck Expects Solid Growth Trends for Cardio-Metabolic Franchise

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SGLT2 inhibitor

Besides Januvia, Merck is working in collaboration with Pfizer (PFE) to expand its cardio-metabolic franchise. The companies have submitted three new drug applications (or NDAs) to the U.S. Food and Drug Administration (or FDA). They’re seeking approval for the investigational Sodium-glucose co-transporter 2 (or SGLT2) inhibitor ertugliflozin as a monotherapy, as well as in combination with Januvia or Metformin, as a treatment option to improve glycemic control in patients suffering from diabetes-2. The FDA has set the Prescription Drug User Fee Act date for these applications in December 2017. Further, these three applications have also been approved for review by the European Medicines Agency (or EMA).

If ertugliflozin manages to secure regulatory approval in the United States and Europe, it may proivde competition for Eli Lilly (LLY) and Boehringer Ingelheim’s Jardiance and AstraZeneca’s (AZN) Farxiga. Increasing revenues for Merck’s cardio-metabolic franchise may also have a favorable impact on share prices for the company as well as the Vanguard S&P 500 ETF (VOO). Merck makes up about 0.85% of VOO’s total portfolio holdings.

Cardiovascular outcomes study

Merck has completed the enrollment of subjects in its cardiovascular outcomes study evaluating ertugliflozin. The company anticipates data from this trial in 2019.

REVEAL study

By mid-2017, Merck expects to review initial data from the REVEAL study, which comprises 30,000 patients and aims to test the efficacy of the investigational Cholesteryl Ester Transfer Protein (or CETP) inhibitor anacetrapib in reducing cardiovascular events in high-risk patients. This once-daily oral formulation is expected to work by reducing serum low-density lipoprotein  (or LDL) cholesterol and increasing high-density lipoprotein (or HDL) cholesterol.

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