Merck and Pfizer Announce U.S. FDA and EMA Filing Acceptances of Three Marketing Applications for Ertugliflozin-Containing Medicines for Adults with Type 2 Diabetes


March 6, 2017 8:00 am ET

Investigational SGLT2 Inhibitor Submitted as Monotherapy and in Fixed-Dose Combinations with JANUVIA ® (sitagliptin) or Metformin

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and
Pfizer Inc. (NYSE:FE), today announced that the U.S. Food and Drug
Administration (FDA) has accepted for review three New Drug Applications
(NDAs) for medicines containing ertugliflozin, an investigational SGLT2
inhibitor in development to help improve glycemic control in adults with
type 2 diabetes: one for monotherapy, one for the fixed-dose combination
of ertugliflozin and JANUVIA® (sitagliptin), and one for the
fixed-dose combination of ertugliflozin and metformin. The Prescription
Drug User Fee Act (PDUFA) action date from the FDA is in December 2017
for the three NDAs. Additionally, the European Medicines Agency (EMA)
has validated for review three Marketing Authorization Applications
(MAAs) for ertugliflozin monotherapy and the two fixed-dose combination

These marketing applications to the FDA and EMA are supported by studies
in the VERTIS clinical development program of ertugliflozin, including
presented at medical congresses in 2016. The full VERTIS clinical
development program is comprised of nine Phase 3 trials in approximately
12,600 adults with type 2 diabetes.

“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,” said Sam Engel, M.D., associate vice
president, Merck clinical research, diabetes and endocrinology. “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.”

“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,” said James Rusnak, M.D., Ph.D., chief development
officer, cardiovascular and metabolic diseases, Pfizer Global Product

Important Information about JANUVIA


(sitagliptin) 25 mg, 50 mg and 100 mg tablets

JANUVIA is indicated as an adjunct to diet and exercise to improve
glycemic control in adults with type 2 diabetes mellitus. JANUVIA should
not be used in patients with type 1 diabetes or for the treatment of
diabetic ketoacidosis. JANUVIA has not been studied in patients with a
history of pancreatitis. It is unknown whether patients with a history
of pancreatitis are at increased risk of developing pancreatitis while
taking JANUVIA.

Selected Important Risk Information about JANUVIA


JANUVIA is contraindicated in patients with a history of a serious
hypersensitivity reaction to sitagliptin, such as anaphylaxis or

There have been postmarketing reports of acute pancreatitis, including
fatal and nonfatal hemorrhagic or necrotizing pancreatitis, in patients
taking JANUVIA. After initiating JANUVIA, observe patients carefully for
signs and symptoms of pancreatitis. If pancreatitis is suspected,
promptly discontinue JANUVIA and initiate appropriate management. It is
unknown whether patients with a history of pancreatitis are at increased
risk of developing pancreatitis while taking JANUVIA.

Assessment of renal function is recommended prior to initiating JANUVIA
and periodically thereafter. A dosage adjustment is recommended in
patients with moderate or severe renal insufficiency and in patients
with end-stage renal disease requiring hemodialysis or peritoneal
dialysis. Caution should be used to ensure that the correct dose of
JANUVIA is prescribed.

There have been postmarketing reports of worsening renal function,
including acute renal failure, sometimes requiring dialysis. A subset of
these reports involved patients with renal insufficiency, some of whom
were prescribed inappropriate doses of sitagliptin.

When JANUVIA was used in combination with a sulfonylurea or insulin,
medications known to cause hypoglycemia, the incidence of hypoglycemia
was increased over that of placebo. Therefore, a lower dose of
sulfonylurea or insulin may be required to reduce the risk of

The incidence (and rate) of hypoglycemia based on all reports of
symptomatic hypoglycemia were: 12.2% (0.59 episodes/patient-year) for
JANUVIA 100 mg in combination with glimepiride (with or without
metformin), 1.8% (0.24 episodes/patient-year) for placebo in combination
with glimepiride (with or without metformin), 15.5% (1.06
episodes/patient-year) for JANUVIA 100 mg in combination with insulin
(with or without metformin), and 7.8% (0.51 episodes/patient-year) for
placebo in combination with insulin (with or without metformin).

There have been postmarketing reports of serious hypersensitivity
reactions in patients treated with JANUVIA, such as anaphylaxis,
angioedema, and exfoliative skin conditions including Stevens –Johnson
syndrome. Onset of these reactions occurred within the first 3 months
after initiation of treatment with JANUVIA, with some reports occurring
after the first dose. If a hypersensitivity reaction is suspected,
discontinue JANUVIA, assess for other potential causes for the event,
and institute alternative treatment for diabetes.

Angioedema has also been reported with other dipeptidyl peptidase-4
(DPP-4) inhibitors. Use caution in a patient with a history of
angioedema with another DPP-4 inhibitor because it is unknown whether
such patients will be predisposed to angioedema with JANUVIA.

There have been postmarketing reports of severe and disabling arthralgia
in patients taking DPP-4 inhibitors. The time to onset of symptoms
following initiation of drug therapy varied from 1 day to years.
Patients experienced relief of symptoms upon discontinuation of the
medication. A subset of patients experienced a recurrence of symptoms
when restarting the same drug or a different DPP-4 inhibitor. Consider
DPP-4 inhibitors as a possible cause for severe joint pain and
discontinue drug if appropriate.

Postmarketing cases of bullous pemphigoid requiring hospitalization have
been reported with DPP-4 inhibitor use. In reported cases, patients
typically recovered with topical or systemic immunosuppressive treatment
and discontinuation of the DPP-4 inhibitor. Tell patients to report
development of blisters or erosions while receiving JANUVIA. If bullous
pemphigoid is suspected, JANUVIA should be discontinued and referral to
a dermatologist should be considered for diagnosis and appropriate

There have been no clinical studies establishing conclusive evidence of
macrovascular risk reduction with JANUVIA or with any other antidiabetic

In clinical studies, the adverse reactions reported, regardless of
investigator assessment of causality, in ≥5% of patients treated with
JANUVIA as monotherapy and in combination therapy and more commonly than
in patients treated with placebo, were upper respiratory tract
infection, nasopharyngitis, and headache.

About Merck

For over a century, Merck has been a global health care leader working
to help the world be well. Merck is known as MSD outside the United
States and Canada. Through our prescription medicines, vaccines,
biologic therapies, and animal health products, we work with customers
and operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to
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About Pfizer Inc.: Working together for a healthier world


At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of health care products. Our global
portfolio includes medicines and vaccines as well as many of the world’s
best-known consumer health care products. Every day, Pfizer colleagues
work across developed and emerging markets to advance wellness,
prevention, treatments and cures that challenge the most feared diseases
of our time. Consistent with our responsibility as one of the world’s
premier innovative biopharmaceutical companies, we collaborate with
health care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world. For
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respect to pipeline products that the products will receive the
necessary regulatory approvals or that they will prove to be
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risks or uncertainties materialize, actual results may differ materially
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Pfizer Disclosure Notice

The information contained in this release is as of March 6, 2017. Pfizer
assumes no obligation to update forward-looking statements contained in
this release as the result of new information or future events or

This release contains forward-looking information about a product
candidate, ertugliflozin, and applications submitted to the FDA and the
EMA for monotherapy and fixed-dose combinations, including their
potential benefits, that involves substantial risks and uncertainties
that could cause actual results to differ materially from those
expressed or implied by such statements. Risks and uncertainties
include, among other things, the uncertainties inherent in research and
development, including the ability to meet anticipated trial
commencement and completion dates and regulatory submission dates, as
well as the possibility of unfavorable clinical trial results, including
unfavorable new clinical data and additional analyses of existing
clinical data; whether and when any applications for ertugliflozin may
be filed with regulatory authorities in any other jurisdictions; whether
and when the FDA and EMA may approve the pending applications and
whether and when regulatory authorities in any other jurisdictions may
approve any such other applications, which will depend on the assessment
by such regulatory authorities of the benefit-risk profile suggested by
the totality of the efficacy and safety information submitted; decisions
by regulatory authorities regarding labeling and other matters that
could affect the availability or commercial potential of ertugliflozin
in monotherapy or in fixed-dose combination; and competitive
developments. The competitive landscape for type 2 diabetes therapies,
including SGLT2 inhibitors, continues to evolve. The success of our
ertugliflozin program is dependent on developments in that space.

A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended December
31, 2016 and in its subsequent reports on Form 10-Q, including in the
sections thereof captioned “Risk Factors” and “Forward-Looking
Information and Factors That May Affect Future Results”, as well as in
its subsequent reports on Form 8-K, all of which are filed with the U.S.
Securities and Exchange Commission and available at and

Please see Prescribing Information for JANUVIA


(sitagliptin) at

and Medication Guide for JANUVIA at

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