New Phase 3 Data Presented at the European
Association for the Study of Diabetes Annual Meeting – Study
Achieved Primary and All Key Secondary Endpoints
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, in partnership with Pfizer Inc. (NYSE: PFE) today announced
that a Phase 3 study (VERTIS SITA2) of ertugliflozin, an
investigational oral SGLT2 inhibitor for the treatment of patients
with type 2 diabetes, met its primary endpoint. Both 5 mg and 15 mg
daily doses of ertugliflozin showed significantly greater
reductions in A1C* of 0.69 percent and 0.76 percent, respectively,
compared with placebo (p<0.001, for both comparisons), when
added to patients on a background of sitagliptin (100 mg/day) and
stable metformin (≥1500 mg/day). These study results were presented
for the first time during an oral session today at the 52nd Annual
Meeting of the European Association for the Study of Diabetes
(EASD) in Munich, Germany.
Merck and Pfizer plan to submit New Drug Applications to the
U.S. Food and Drug Administration for ertugliflozin and two
fixed-dose combinations (ertugliflozin plus JANUVIA® (sitagliptin)
and ertugliflozin plus metformin) by the end of 2016, with
additional regulatory submissions outside of the U.S. to follow in
2017.
“It is encouraging to see further data from the VERTIS clinical
development program in support of combining ertugliflozin, an SGLT2
inhibitor, with the DPP-4 inhibitor sitagliptin, which was first
approved 10 years ago,” said Peter Stein, M.D., vice president,
late stage development, diabetes and endocrinology, Merck.
In this double-blind, randomized, placebo-controlled study, 463
patients with type 2 diabetes and a baseline A1C of 7.0 – 10.5
percent were randomized to receive ertugliflozin 5 mg,
ertugliflozin 15 mg, or placebo in a 1:1:1 ratio. In addition to
meeting the primary endpoint of reducing A1C at 26 weeks,
ertugliflozin also met the following key secondary endpoints in the
study:
- A greater proportion of patients taking
ertugliflozin 5 mg and 15 mg achieved the A1C treatment goal of
less than 7.0 percent (32.1 percent and 39.9 percent, respectively)
compared with the placebo group (17.0 percent) (p<0.001, for
both comparisons based on adjusted odds ratios);
- Placebo-adjusted mean reduction in body
weight of 4.4 lbs (2.0 kg) for the 5 mg dose and 3.7 lbs (1.7 kg)
for the 15 mg dose (p<0.001, for both comparisons);
- Placebo-adjusted mean reductions in
fasting plasma glucose (FPG) of 25.1 mg/dl (1.4 mmol/L) for the 5
mg dose and 31.3 mg/dl (1.7 mmol/L) for the 15 mg dose (p<0.001,
for both comparisons);
- Placebo-adjusted mean reductions in
systolic blood pressure of 2.9 mmHg (5 mg, p=0.019) and 3.9 mmHg
(15 mg, p=0.002).
“We are pleased to share these new data on investigational
ertugliflozin with the scientific community, following the first
presentations of Phase 3 data for ertugliflozin at the American
Diabetes Association’s 76th Scientific Sessions in June,” said
James Rusnak, M.D., Ph.D., chief development officer,
cardiovascular & metabolics, Pfizer. “Type 2 diabetes is a
progressive disease and these study results help support the
clinical profile of ertugliflozin as an add-on therapy for patients
who may require multiple treatment combinations to help reach their
blood sugar goals.”
Overall adverse event (AE) rates were generally similar between
ertugliflozin 5 mg (41.7 percent), ertugliflozin 15 mg (43.8
percent) and placebo (48.4 percent), with a similar rate of one or
more serious AEs across all groups (4.5 percent for ertugliflozin 5
mg; 2.0 percent for ertugliflozin 15 mg; 3.3 percent for placebo).
The rates of discontinuations due to AEs were low across all groups
(3.2 percent for ertugliflozin 5 mg; 0.7 percent for ertugliflozin
15 mg; 0.7 percent for placebo). In the study, a higher incidence
of genital mycotic infections was observed in patients taking
ertugliflozin 5 mg and ertugliflozin 15 mg (males: 4.9 percent and
3.7 percent, respectively, vs. no events for placebo; females: 8.0
percent and 12.7 percent, respectively, vs. 1.9 percent for
placebo). Urinary tract infection rates were low across the
ertugliflozin 5 mg, ertugliflozin 15 mg and placebo groups (2.6
percent, 4.6 percent and 2.0 percent, respectively). Across groups,
there were similar rates for symptomatic hypoglycemia (3.8 percent
for ertugliflozin 5 mg; 0.7 percent for ertugliflozin 15 mg; 2.6
percent for placebo) and for hypovolemia adverse events (0.6
percent for ertugliflozin 5 mg; no events for ertugliflozin 15 mg;
0.7 percent for placebo).
About the VERTIS Clinical Development Program for
Ertugliflozin
In addition to the VERTIS MONO and VERTIS FACTORIAL studies,
which were presented at the 76th Scientific Sessions of the
American Diabetes Association, VERTIS SITA2 is a part of the VERTIS
clinical development program comprised of a total of nine Phase 3
trials in approximately 12,600 adults with type 2 diabetes. Results
from the other six VERTIS trials will be submitted for publication
and/or presentation at future scientific congresses.
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 angioedema.
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 hypoglycemia.
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.
There have been no clinical studies establishing conclusive
evidence of macrovascular risk reduction with JANUVIA or with any
other antidiabetic drug.
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 125 years, 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 health care through far-reaching policies,
programs and partnerships. For more information, visit
www.merck.com and connect with us on Twitter, Facebook, YouTube and
LinkedIn.
About Pfizer Inc.
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 healthcare
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. For more information, please visit us
at www.pfizer.com. In addition, to learn more, follow us on
Twitter @Pfizer
and @Pfizer_News, LinkedIn, YouTube and like us on
Facebook at Facebook.com/Pfizer.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’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; the company’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 the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company 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 the company’s 2015
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 (www.sec.gov).
Pfizer Disclosure Notice
The information contained in this release is as of September 15,
2016. 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 a
product candidate, ertugliflozin, including its 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 jurisdictions;
whether and when regulatory authorities in any jurisdictions may
approve such 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; and competitive developments. The competitive
landscape for type 2 diabetes therapies, including SGLT
2-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, 2015 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 www.sec.gov and www.pfizer.com.
*A1C is an average measure of blood glucose over the past two to
three months
Please see Prescribing Information for JANUVIA®
(sitagliptin) at
http://www.merck.com/product/usa/pi_circulars/j/januvia/januvia_pi.pdf
and Medication Guide for JANUVIA at
http://www.merck.com/product/usa/pi_circulars/j/januvia/januvia_mg.pdf
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Pfizer MediaSteven Danehy, 212-733-1538orPfizer InvestorRyan
Crowe, 212-733-8160orMerck MediaDoris Li, 908-246-5701Kristen
Drake, 908-334-4688orMerck InvestorAmy Klug, 908-740-1898
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