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December 12, 2016 7:00 am ET

KENILWORTH, N.J. & WOODCLIFF LAKE, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, and
Eisai Inc. today announced new interim data investigating Merck’s
anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab), in combination
with Eisai’s microtubule dynamics inhibitor, HALAVEN^®
(eribulin), in patients with metastatic triple-negative breast cancer
(TNBC). Findings presented during the 2016 San Antonio Breast Cancer
Symposium (SABCS) were based on interim data from 39 evaluable patients
and showed an overall response rate (ORR) of 33.3% (n=13/39; 95% CI,
19.5-48.1), with one complete response and 12 partial responses
(Abstract #: P5-15-02). ORR was similar between PD-L1-positive and
-negative cohorts [PD-L1 positive=29.4% (n=5/17; 95% CI, 11.1-51.1);
PD-L1 negative=33.3% (n=6/18; 95% CI, 14.1-54.6)]. HALAVEN and KEYTRUDA
are not approved for use in combination.

The most common treatment-emergent adverse events (incidence greater
than or equal to 35%) for the combination regimen were fatigue (n=29;
74.4%), nausea (n=20; 51.3%), peripheral neuropathy (n=17; 43.6%),
neutropenia (n=15; 38.5%), and alopecia (n=14; 35.9%), with grade 3 or
higher treatment-emergent adverse events observed in 66.7% (n=26) of
patients. The two most common grade 3 or higher treatment-emergent
adverse events observed were neutropenia (n=12; 30.8%) and fatigue (n=3;
7.7%). The possible immune-mediated adverse events of clinical interest
with KEYTRUDA (grade 3/4) included rash (n=2; 5.1%), pneumonitis (n=1;
2.6%), hyperglycemia (n=1; 2.6%), renal failure (n=1; 2.6%) and rash
generalized (n=1; 2.6%). Events of clinical interest for HALAVEN (grade
3/4) included neutropenia (n=11, 28.2%), febrile neutropenia (n=1;
2.6%), and peripheral neuropathy (n=1; 2.6%). There were 10
discontinuations due to treatment-emergent adverse events and no
treatment-related deaths.

“Little progress has been made in metastatic triple-negative breast
cancer, which is an aggressive and difficult-to-treat cancer. This
initial evaluation of the combination of KEYTRUDA and HALAVEN is
encouraging and represents an important part of our multi-pronged effort
to bring forward new potential approaches for patients with this type of
cancer,” said Roger Dansey, M.D., senior vice president and therapeutic
area head, oncology late-stage development, Merck Research Laboratories.

“Patients with metastatic triple-negative breast cancer have a limited
number of treatment options, making clinical study of new potential
therapeutic approaches essential,” said Alton Kremer, M.D., Ph.D., chief
clinical officer and chief medical officer, Oncology Business Group at
Eisai. “With this ongoing study, we hope to learn more about the
potential of HALAVEN as part of a combination regimen with KEYTRUDA,
with the long-term goal of addressing the unmet medical needs of
patients with metastatic triple-negative breast cancer.”

“In addition to anti-mitotic effects, in preclinical and translational
studies, eribulin induced tumor vascular remodeling, reduction of
hypoxia and promotion of the less aggressive epithelial phenotype in
advanced breast cancer tumor tissue. We look forward to further
understanding how these effects of eribulin on tumor biology and
microenvironment may impact the effect of pembrolizumab on the immune
system’s T cells,” said Sara Tolaney, M.D., MPH, medical oncologist,
Dana-Farber Cancer Institute, Boston, and the principal investigator of
the study.

HALAVEN (eribulin mesylate) Injection is approved by the U.S. Food and
Drug Administration (FDA) for the treatment of patients with metastatic
breast cancer who have previously received at least two chemotherapeutic
regimens for the treatment of metastatic disease. Prior therapy should
have included an anthracycline and a taxane in either the adjuvant or
metastatic setting. KEYTRUDA (pembrolizumab) is not indicated in any
type of breast cancer. This release discusses investigational uses for
FDA-approved products. This release is not intended to convey
conclusions about efficacy or safety. There is no guarantee that any
investigational uses of such FDA-approved products will successfully
complete clinical development or gain FDA approval.

About the Study

The single-arm, multi-center phase 1b/2 study (ClinicalTrials.gov
Identifier: NCT02513472) is investigating the combination of KEYTRUDA
(pembrolizumab) (200 mg intravenously on Day 1) with HALAVEN (eribulin
mesylate) Injection (1.4 mg/m² intravenously on Day 1 and Day
8) in 21-day cycles in 95 patients with metastatic TNBC who had
previously been treated with up to two lines of chemotherapy. The
primary endpoint of the phase 1b portion of the study is to assess the
safety and tolerability of the combination; for the phase 2 portion of
the study, the primary endpoint is investigator-assessed ORR and
secondary endpoints include progression-free survival, overall survival
and duration of response as well as efficacy in a subset of patients
with PD-L1-positive tumors.

The results presented at SABCS were based on a planned interim analysis.
At the time of data cutoff (July 12, 2016), 89 patients were enrolled,
39 of whom were evaluable.

The study is being conducted under an existing clinical trial
collaboration agreement between the two companies.

About Breast Cancer

Breast cancer is a malignant tumor that begins in the cells of the
breast. In 2016, an estimated 246,660 women will be diagnosed with
breast cancer in the United States, and nearly 40,450 women will die
from the disease.

Triple-negative breast cancer is an aggressive type of breast cancer
where the cancer cells do not have estrogen or progesterone receptors
and do not have HER2, a growth-promoting protein. Approximately 12% of
breast cancer patients are diagnosed with triple-negative breast cancer.
Triple-negative breast cancer tends to grow and spread quickly.
Specifically, patients with triple-negative breast cancer are nearly two
times more likely to have distant metastatic disease than those with
most other types of breast cancer.

Metastatic breast cancer is an advanced stage of the disease that occurs
when cancer spreads beyond the breast to other parts of the body. It is
estimated that approximately five percent to 10 percent of women with
breast cancer will have metastatic disease at the time of diagnosis. Of
these women, an estimated one in five is expected to survive five years.

About KEYTRUDA

^®

(pembrolizumab)

KEYTRUDA is a humanized monoclonal antibody that works by increasing the
ability of the body’s immune system to help detect and fight tumor
cells. KEYTRUDA blocks the interaction between PD-1 and its ligands,
PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both
tumor cells and healthy cells.

KEYTRUDA (pembrolizumab) is administered as an intravenous infusion over
30 minutes every three weeks for the approved indications. KEYTRUDA for
injection is supplied in a 100 mg single use vial.

KEYTRUDA Indications and Dosing

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or
metastatic melanoma at a dose of 2 mg/kg every three weeks until disease
progression or unacceptable toxicity.

Lung Cancer

KEYTRUDA is indicated for the first-line treatment of patients with
metastatic non-small cell lung cancer (NSCLC) whose tumors have high
PD-L1 expression [tumor proportion score (TPS) ≥50%] as determined by an
FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA is also indicated for the treatment of patients with metastatic
NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an
FDA-approved test, with disease progression on or after
platinum-containing chemotherapy. Patients with EGFR or ALK genomic
tumor aberrations should have disease progression on FDA-approved
therapy for these aberrations prior to receiving KEYTRUDA.

In metastatic NSCLC, KEYTRUDA is administered at a fixed dose of 200 mg
every three weeks until disease progression, unacceptable toxicity, or
up to 24 months in patients without disease progression.

Head and Neck Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or
metastatic head and neck squamous cell carcinoma (HNSCC) with disease
progression on or after platinum-containing chemotherapy. This
indication is approved under accelerated approval based on tumor
response rate and durability of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in the confirmatory trials. In HNSCC, KEYTRUDA is
administered at a fixed dose of 200 mg every three weeks until disease
progression, unacceptable toxicity, or up to 24 months in patients
without disease progression.

Selected Important Safety Information for KEYTRUDA

^®
 (pembrolizumab)

KEYTRUDA (pembrolizumab) can cause immune-mediated pneumonitis,
including fatal cases. Pneumonitis occurred in 94 (3.4%) of 2799
patients receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3
(0.9%), 4 (0.3%), and 5 (0.1%) pneumonitis, and occurred more frequently
in patients with a history of prior thoracic radiation (6.9%) compared
to those without (2.9%). Monitor patients for signs and symptoms of
pneumonitis. Evaluate suspected pneumonitis with radiographic imaging.
Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold
KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4
or recurrent Grade 2 pneumonitis.

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 48
(1.7%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.4%), 3
(1.1%), and 4 (<0.1%) colitis. Monitor patients for signs and symptoms
of colitis. Administer corticosteroids for Grade 2 or greater colitis.
Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for
Grade 4 colitis.

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 19
(0.7%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.1%), 3
(0.4%), and 4 (<0.1%) hepatitis. Monitor patients for changes in liver
function. Administer corticosteroids for Grade 2 or greater hepatitis
and, based on severity of liver enzyme elevations, withhold or
discontinue KEYTRUDA.

KEYTRUDA can cause hypophysitis. Hypophysitis occurred in 17 (0.6%) of
2799 patients receiving KEYTRUDA, including Grade 2 (0.2%), 3 (0.3%),
and 4 (<0.1%) hypophysitis. Monitor patients for signs and symptoms of
hypophysitis (including hypopituitarism and adrenal insufficiency).
Administer corticosteroids and hormone replacement as clinically
indicated. Withhold KEYTRUDA for Grade 2; withhold or discontinue for
Grade 3 or 4 hypophysitis.

KEYTRUDA can cause thyroid disorders, including hyperthyroidism,
hypothyroidism, and thyroiditis. Hyperthyroidism occurred in 96 (3.4%)
of 2799 patients receiving KEYTRUDA, including Grade 2 (0.8%) and 3
(0.1%) hyperthyroidism. Hypothyroidism occurred in 237 (8.5%) of 2799
patients receiving KEYTRUDA, including Grade 2 (6.2%) and 3 (0.1%)
hypothyroidism. The incidence of new or worsening hypothyroidism was
higher in patients with HNSCC occurring in 28 (15%) of 192 patients with
HNSCC, including Grade 3 (0.5%) hypothyroidism. Thyroiditis occurred in
16 (0.6%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.3%)
thyroiditis. Monitor patients for changes in thyroid function (at the
start of treatment, periodically during treatment, and as indicated
based on clinical evaluation) and for clinical signs and symptoms of
thyroid disorders. Administer replacement hormones for hypothyroidism
and manage hyperthyroidism with thionamides and beta-blockers as
appropriate. Withhold or discontinue KEYTRUDA (pembrolizumab) for Grade
3 or 4 hyperthyroidism.

KEYTRUDA can cause type 1 diabetes mellitus, including diabetic
ketoacidosis, which have been reported in 6 (0.2%) of 2799 patients.
Monitor patients for hyperglycemia or other signs and symptoms of
diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA
and administer antihyperglycemics in patients with severe hyperglycemia.

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 9
(0.3%) of 2799 patients receiving KEYTRUDA, including Grade 2 (0.1%), 3
(0.1%), and 4 (<0.1%) nephritis. Monitor patients for changes in renal
function. Administer corticosteroids for Grade 2 or greater nephritis.
Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for
Grade 3 or 4 nephritis.

KEYTRUDA can cause other clinically important immune-mediated adverse
reactions. For suspected immune-mediated adverse reactions, ensure
adequate evaluation to confirm etiology or exclude other causes. Based
on the severity of the adverse reaction, withhold KEYTRUDA and
administer corticosteroids. Upon improvement to Grade 1 or less,
initiate corticosteroid taper and continue to taper over at least 1
month. Based on limited data from clinical studies in patients whose
immune-related adverse reactions could not be controlled with
corticosteroid use, administration of other systemic immunosuppressants
can be considered. Resume KEYTRUDA when the adverse reaction remains at
Grade 1 or less following corticosteroid taper. Permanently discontinue
KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs
and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions
occurred in less than 1% (unless otherwise indicated) of 2799 patients:
arthritis (1.5%), exfoliative dermatitis, bullous pemphigoid, rash
(1.4%), uveitis, myositis, Guillain-Barré syndrome, myasthenia gravis,
vasculitis, pancreatitis, hemolytic anemia, and partial seizures arising
in a patient with inflammatory foci in brain parenchyma.

KEYTRUDA can cause severe or life-threatening infusion-related
reactions, which have been reported in 6 (0.2%) of 2799 patients.
Monitor patients for signs and symptoms of infusion-related reactions,
including rigors, chills, wheezing, pruritus, flushing, rash,
hypotension, hypoxemia, and fever. For Grade 3 or 4 reactions, stop
infusion and permanently discontinue KEYTRUDA.

Based on its mechanism of action, KEYTRUDA can cause fetal harm when
administered to a pregnant woman. If used during pregnancy, or if the
patient becomes pregnant during treatment, apprise the patient of the
potential hazard to a fetus. Advise females of reproductive potential to
use highly effective contraception during treatment and for 4 months
after the last dose of KEYTRUDA (pembrolizumab).

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9%
of 555 patients with advanced melanoma; adverse reactions leading to
discontinuation in more than one patient were colitis (1.4%), autoimmune
hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and
cardiac failure (0.4%). Adverse reactions leading to interruption of
KEYTRUDA occurred in 21% of patients; the most common (≥1%) was diarrhea
(2.5%). The most common adverse reactions with KEYTRUDA vs ipilimumab
were fatigue (28% vs 28%), diarrhea (26% with KEYTRUDA), rash (24% vs
23%), and nausea (21% with KEYTRUDA). Corresponding incidence rates are
listed for ipilimumab only for those adverse reactions that occurred at
the same or lower rate than with KEYTRUDA.

In KEYNOTE-002, KEYTRUDA was discontinued due to adverse reactions in
12% of 357 patients with advanced melanoma; the most common (≥1%) were
general physical health deterioration (1%), asthenia (1%), dyspnea (1%),
pneumonitis (1%), and generalized edema (1%). Adverse reactions leading
to interruption of KEYTRUDA occurred in 14% of patients; the most common
(≥1%) were dyspnea (1%), diarrhea (1%), and maculopapular rash (1%). The
most common adverse reactions with KEYTRUDA vs chemotherapy were fatigue
(43% with KEYTRUDA), pruritus (28% vs 8%), rash (24% vs 8%),
constipation (22% vs 20%), nausea (22% with KEYTRUDA), diarrhea (20% vs
20%), and decreased appetite (20% with KEYTRUDA). Corresponding
incidence rates are listed for chemotherapy only for those adverse
reactions that occurred at the same or lower rate than with KEYTRUDA.

KEYTRUDA was discontinued due to adverse reactions in 8% of 682 patients
with metastatic NSCLC. The most common adverse event resulting in
permanent discontinuation of KEYTRUDA was pneumonitis (1.8%). Adverse
reactions leading to interruption of KEYTRUDA occurred in 23% of
patients; the most common (≥1%) were diarrhea (1%), fatigue (1.3%),
pneumonia (1%), liver enzyme elevation (1.2%), decreased appetite
(1.3%), and pneumonitis (1%). The most common adverse reactions
(occurring in at least 20% of patients and at a higher incidence than
with docetaxel) were decreased appetite (25% vs 23%), dyspnea (23% vs
20%), and nausea (20% vs 18%).

KEYTRUDA was discontinued due to adverse reactions in 17% of 192
patients with HNSCC. Serious adverse reactions occurred in 45% of
patients. The most frequent serious adverse reactions reported in at
least 2% of patients were pneumonia, dyspnea, confusional state,
vomiting, pleural effusion, and respiratory failure. The most common
adverse reactions (reported in at least 20% of patients) were fatigue,
decreased appetite, and dyspnea. Adverse reactions occurring in patients
with HNSCC were generally similar to those occurring in patients with
melanoma or NSCLC, with the exception of increased incidences of facial
edema (10% all Grades; 2.1% Grades 3 or 4) and new or worsening
hypothyroidism.

It is not known whether KEYTRUDA (pembrolizumab) is excreted in human
milk. Because many drugs are excreted in human milk, instruct women to
discontinue nursing during treatment with KEYTRUDA and for 4 months
after the final dose.

Safety and effectiveness of KEYTRUDA have not been established in
pediatric patients.

For more information about KEYTRUDA, please see the Prescribing
Information for KEYTRUDA (pembrolizumab) at 

http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf

 and

Patient Information/Medication Guide for KEYTRUDA at 

http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf
”

About HALAVEN

^®

(eribulin mesylate) Injection

HALAVEN^® (eribulin mesylate) is a microtubule dynamics
inhibitor indicated for the treatment of patients with:

• Metastatic breast cancer who have previously received at least two
  chemotherapeutic regimens for the treatment of metastatic disease.
  Prior therapy should have included an anthracycline and a taxane in
  either the adjuvant or metastatic setting.
• Unresectable or metastatic liposarcoma who have received a prior
  anthracycline- containing regimen.

Discovered and developed by Eisai, eribulin is a synthetic analog of
halichondrin B, a natural product that was isolated from the marine
sponge Halichondria okadai. First in the halichondrin class,
Halaven is a microtubule dynamics inhibitor. Eribulin is believed to
work primarily via a tubulin-based mechanism that causes prolonged and
irreversible mitotic blockage, ultimately leading to apoptotic cell
death. Additionally, in preclinical studies of human breast cancer,
eribulin demonstrated complex effects on the tumor biology of surviving
cancer cells, including increases in vascular perfusion resulting in
reduced tumor hypoxia, and changes in the expression of genes in tumor
specimens associated with a change in phenotype, promoting the
epithelial phenotype, opposing the mesenchymal phenotype. Eribulin has
also been shown to decrease the migration and invasiveness of human
breast cancer cells.

Important Safety Information for Halaven (eribulin mesylate) Injection

Warnings and Precautions

Neutropenia: Severe neutropenia (ANC <500/mm³)
lasting >1 week occurred in 12% of patients with mBC and liposarcoma or
leiomyosarcoma. Febrile neutropenia occurred in 5% of patients with mBC
and 2 patients (0.4%) died from complications. Febrile neutropenia
occurred in 0.9% of patients with liposarcoma or leiomyosarcoma, and
fatal neutropenic sepsis occurred in 0.9% of patients. Patients with mBC
with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN
experienced a higher incidence of Grade 4 neutropenia and febrile
neutropenia than patients with normal levels. Monitor complete blood
cell counts prior to each dose, and increase the frequency of monitoring
in patients who develop Grade 3 or 4 cytopenias. Delay administration
and reduce subsequent doses in patients who experience febrile
neutropenia or Grade 4 neutropenia lasting >7 days.

Peripheral Neuropathy: Grade 3 peripheral neuropathy occurred in
8% of patients with mBC (Grade 4=0.4%) and 22% developed a new or
worsening neuropathy that had not recovered within a median follow-up
duration of 269 days (range 25-662 days). Neuropathy lasting >1 year
occurred in 5% of patients with mBC. Grade 3 peripheral neuropathy
occurred in 3.1% of patients with liposarcoma and leiomyosarcoma
receiving Halaven and neuropathy lasting more than 60 days occurred in
58% (38/65) of patients who had neuropathy at the last treatment visit.
Patients should be monitored for signs of peripheral motor and sensory
neuropathy. Withhold Halaven in patients who experience Grade 3 or 4
peripheral neuropathy until resolution to Grade 2 or less.

Embryo-Fetal Toxicity: Halaven can cause fetal harm when
administered to a pregnant woman. Advise females of reproductive
potential to use effective contraception during treatment with Halaven
and for at least 2 weeks following the final dose. Advise males with
female partners of reproductive potential to use effective contraception
during treatment with Halaven and for 3.5 months following the final
dose.

QT Prolongation: Monitor for prolonged QT intervals in patients
with congestive heart failure, bradyarrhythmias, drugs known to prolong
the QT interval, and electrolyte abnormalities. Correct hypokalemia or
hypomagnesemia prior to initiating Halaven and monitor these
electrolytes periodically during therapy. Avoid in patients with
congenital long QT syndrome.

Adverse Reactions

In patients with mBC receiving Halaven (eribulin mesylate) Injection,
the most common adverse reactions (≥25%) were neutropenia (82%), anemia
(58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy
(35%), nausea (35%), and constipation (25%). Febrile neutropenia (4%)
and neutropenia (2%) were the most common serious adverse reactions. The
most common adverse reaction resulting in discontinuation was peripheral
neuropathy (5%).

In patients with liposarcoma and leiomyosarcoma receiving Halaven, the
most common adverse reactions (≥25%) reported in patients receiving
Halaven were fatigue (62%), nausea (41%), alopecia (35%), constipation
(32%), peripheral neuropathy (29%), abdominal pain (29%), and pyrexia
(28%). The most common (≥5%) Grade 3-4 laboratory abnormalities reported
in patients receiving Halaven were neutropenia (32%), hypokalemia
(5.4%), and hypocalcemia (5%). Neutropenia (4.9%) and pyrexia (4.5%)
were the most common serious adverse reactions. The most common adverse
reactions resulting in discontinuation were fatigue and thrombocytopenia
(0.9% each).

Use in Specific Populations

Lactation: Because of the potential for serious adverse reactions
in breastfed infants from eribulin mesylate, advise women not to
breastfeed during treatment with Halaven and for 2 weeks after the final
dose.

Hepatic and Renal Impairment: A reduction in starting dose is
recommended for patients with mild or moderate hepatic impairment and/or
moderate or severe renal impairment.

For more information about Halaven, click here
for the full Prescribing Information.

Merck’s Focus on Cancer

Merck’s goal is to translate breakthrough science into innovative
oncology medicines to help people with cancer worldwide. At Merck,
helping people fight cancer is our passion and supporting accessibility
to our cancer medicines is our commitment. Our focus is on pursuing
research in immuno-oncology and we are accelerating every step in the
journey – from lab to clinic – to potentially bring new hope to people
with cancer.

As part of our focus on cancer, Merck is committed to exploring the
potential of immuno-oncology with one of the fastest-growing development
programs in the industry. We are currently executing an expansive
research program that includes nearly 400 clinical trials evaluating our
anti-PD-1 therapy across more than 30 tumor types. We also continue to
strengthen our immuno-oncology portfolio through strategic acquisitions
and are prioritizing the development of several promising
immunotherapeutic candidates with the potential to improve the treatment
of advanced cancers.

For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

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 Eisai Inc.

At Eisai Inc., human health care (hhc) is our goal. We
give our first thought to patients and their families, and helping to
increase the benefits health care provides. As the U.S. pharmaceutical
subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate
commitment to patient care that is the driving force behind our efforts
to discover and develop innovative therapies to help address unmet
medical needs.

Eisai is a fully integrated pharmaceutical business that operates in two
global business groups: oncology and neurology (dementia-related
diseases and neurodegenerative diseases). Each group functions as an
end-to-end global business with discovery, development, and marketing
capabilities. Our U.S. headquarters, commercial and clinical development
organizations are located in New Jersey; our discovery labs are in
Massachusetts and Pennsylvania; and our global demand chain organization
resides in Maryland and North Carolina. To learn more about Eisai Inc.,
please visit us at www.eisai.com/US.

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).

Media:
Merck
Pamela Eisele, 267-305-3558
or
Kim Hamilton, (908) 740-1863
or
Eisai Inc.
Laurie Landau, 201-746-2510
or
Investors:
Merck
Teri Loxam, 908-740-1986
or
Amy Klug, 908-740-1898
or
Eisai Inc.
Ivor Macleod, 201-746-2660