Where Merck and Pfizer's Type 2 Diabetes Treatment Can Go From Here

Health and Healthcare

Published: March 6, 2017 9:50 am

Last Updated: January 12, 2020 2:14 pm

Merck & Co. Inc. (NYSE: MRK) and Pfizer Inc. (NYSE: PFE) each saw their shares sink early on Monday after they gave an update on their type 2 diabetes treatment. The companies announced that the U.S. Food and Drug Administration (FDA) has accepted for review three New Drug Applications (NDAs) for medicines containing ertugliflozin.

The Prescription Drug User Fee Act (PDUFA) action date from the FDA is December 2017 for the three NDAs. At the same time, the European Medicines Agency (EMA) has validated for review three Marketing Authorization Applications (MAAs) for ertugliflozin monotherapy and the two fixed-dose combination products.

These marketing applications to the FDA and EMA are supported by studies in the Vertis clinical development program of ertugliflozin, including Vertis Mono, Vertis Factorial and Vertis Sita2, which were first presented at medical congresses in 2016.

The full Vertis clinical development program is comprised of nine Phase 3 trials in roughly 12,600 adults with type 2 diabetes.

Sam Engel, M.D., associate vice president, Merck clinical research, diabetes and endocrinology, commented:

The acceptance of the three applications by both the FDA and EMA represents an important milestone in the progression of our collaboration with Pfizer on ertugliflozin, and reflects Merck’s commitment to advancing new treatment options for people with type 2 diabetes around the world. If approved, we believe ertugliflozin will be an important option for many patients and a welcome addition to our already strong type 2 diabetes portfolio, with our DPP-4 inhibitor JANUVIA as the foundation.

James Rusnak, M.D., Ph.D., chief development officer, cardiovascular and metabolic diseases, Pfizer Global Product Development, added:

Because type 2 diabetes is a progressive disease, patients may need multiple treatment options to help them manage their condition. That is why we are proud of the comprehensive VERTIS clinical development program, and we look forward to working closely with the FDA and EMA in an effort to bring these three additional treatment options to adults with type 2 diabetes.

Shares of Merck were trading down 0.7% at $66.14, within a 52-week trading range of $51.33 to $66.80 and with a consensus analyst price target of $68.65.

Pfizer shares were down 0.7% at $34.29. The consensus price target is $37.95, and the 52-week range is $28.74 to $37.39.

Take Charge of Your Retirement In Just A Few Minutes (Sponsor)

Retirement planning doesn’t have to feel overwhelming. The key is finding expert guidance—and SmartAsset’s simple quiz makes it easier than ever for you to connect with a vetted financial advisor.

Here’s how it works:

Answer a Few Simple Questions. Tell us a bit about your goals and preferences—it only takes a few minutes!
Get Matched with Vetted Advisors Our smart tool matches you with up to three pre-screened, vetted advisors who serve your area and are held to a fiduciary standard to act in your best interests. Click here to begin
Choose Your Fit Review their profiles, schedule an introductory call (or meet in person), and select the advisor who feel is right for you.

Why wait? Start building the retirement you’ve always dreamed of. Click here to get started today!