Merck & Co., Inc. and Pfizer Enter Worldwide Collaboration Agreement to Develop and Commercialize Ertugliflozin, an Investigational Medicine for Type 2 Diabetes


April 29, 2013 6:30 am ET

Merck & Co., Inc. (NYSE: MRK), known as MSD outside the United States
and Canada (“Merck”), and Pfizer Inc. (NYSE:PFE) today announced that
they have entered into a worldwide (except Japan) collaboration
agreement for the development and commercialization of Pfizer’s
ertugliflozin (PF-04971729), an investigational oral sodium glucose
cotransporter (SGLT2) inhibitor being evaluated for the treatment of
type 2 diabetes. Ertugliflozin is Phase III ready, with trials expected
to begin later in 2013.

“We are pleased to join forces with Merck in the battle against type 2
diabetes and the burden that it poses on global health,” said John
Young, president and general manager, Pfizer Primary Care. “Through this
collaboration, we believe we can build on Merck’s leadership position in
diabetes care with the introduction of ertugliflozin, an innovative
SGLT2 inhibitor discovered by Pfizer scientists.”

Under the terms of the agreement, Merck, through a subsidiary, and
Pfizer will collaborate on the clinical development and
commercialization of ertugliflozin and ertugliflozin-containing
fixed-dose combinations with metformin and JANUVIA®
(sitagliptin) tablets. Merck will continue to retain the rights to its
existing portfolio of sitagliptin-containing products. Pfizer has
received an upfront payment and milestones of $60 million and will be
eligible for additional payments associated with the achievement of
pre-specified future clinical, regulatory and commercial milestones.
Merck and Pfizer will share potential revenues and certain costs on a
60/40 percent basis.

“Merck continues to build upon our leadership position in the oral
treatment of type 2 diabetes through our own research and business
development,” said Nancy Thornberry, senior vice president and Diabetes
and Endocrinology franchise head, Merck Research Laboratories. “We
believe ertugliflozin has the potential to complement our strong
portfolio of investigational and marketed products, and we look forward
to collaborating with Pfizer on its development.”

About JANUVIA® (sitagliptin) 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 percent (0.59 episodes per
patient-year) for JANUVIA® (sitagliptin) 100 mg in
combination with glimepiride (with or without metformin), 1.8 percent
(0.24 episodes per patient-year) for placebo in combination with
glimepiride (with or without metformin), 15.5 percent (1.06 episodes per
patient-year) for JANUVIA 100 mg in combination with insulin (with or
without metformin), and 7.8 percent (0.51 episodes per 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 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 greater than or equal to 5
percent 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

About Merck

Today’s Merck is a global healthcare 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
consumer care 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
healthcare through far-reaching policies, programs and partnerships. For
more information, visit
and connect with us on Twitter,
and YouTube.

Pfizer Inc.: Working together for a healthier

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
more than 150 years, Pfizer has worked to make a difference for all who
rely on us. To learn more, please visit us at

Merck Forward-Looking Statement

This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. These statements are based
upon the current beliefs and expectations of Merck’s management and are
subject to significant risks and uncertainties. There can be no
guarantees with respect to pipeline products that the products will
receive the necessary regulatory approvals or that they will prove to be
commercially successful. If underlying assumptions prove inaccurate or
risks or uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; Merck’s ability to accurately
predict future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign risk;
dependence on the effectiveness of Merck’s patents and other protections
for innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can be
found in Merck’s 2012 Annual Report on Form 10-K and the company’s other
filings with the Securities and Exchange Commission (SEC) available at
the SEC’s Internet site (

Pfizer Disclosure Notice

The information contained in this release is as of April 29, 2013.
Pfizer assumes no obligation to update forward-looking statements
contained in this release as the result of new information or future
events or developments.

This release contains forward-looking information about ertugliflozin,
an investigational oral SGLT2 inhibitor being evaluated for the
treatment of type 2 diabetes, and a collaboration agreement between
Pfizer and Merck for the development and commercialization of
ertugliflozin, including their potential benefits, that involves
substantial risks and uncertainties. Such risks and uncertainties
include, among other things:

  • the uncertainties inherent in research and development, including the
    ability to meet anticipated clinical trial commencement and completion
    dates, regulatory submission and approval dates, and launch dates, as
    well as the possibility of unfavorable clinical trial results,
    including unfavorable new clinical data or additional analyses of
    existing clinical data;
  • decisions by regulatory authorities regarding whether and when to
    approve any drug applications that may be filed for any potential
    indication for ertugliflozin as well as their decisions regarding
    labeling and other matters that could affect the availability or
    commercial potential of any such potential indication and competitive

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, 2012 and in its reports on Form 10-Q and Form 8-K.

Prescribing Information and Medication Guide for JANUVIA®
(sitagliptin) are available at

Merck Media Relations:
Steven Cragle: (908) 423-3461
Kim Hamilton: (908) 423-6831
Pfizer Media Relations:
Joan Campion: (212) 733-2798
Merck Investor Relations:
Carol Ferguson: (908) 423-4465
Justin Holko: (908) 423-5088
Pfizer Investor Relations:
Chuck Triano: (212) 733-3901

Unsubscribe from email alerts