First and only PARP inhibitor to improve
invasive disease-free survival, the primary endpoint, and overall
survival, a key secondary endpoint, in these patients
AstraZeneca and Merck (NYSE: MRK), known as MSD outside the
United States and Canada, today announced that the European
Medicines Agency’s Committee for Medicinal Products for Human Use
(CHMP) has adopted a positive opinion recommending approval of
LYNPARZA for the adjuvant treatment of patients with germline
BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2
(HER2)-negative high-risk early breast cancer who have been treated
with neoadjuvant or adjuvant chemotherapy.
The CHMP based its positive opinion on results from the Phase 3
OlympiA trial presented during the 2021 American Society of
Clinical Oncology Annual Meeting and published in The New England
Journal of Medicine in June 2021.
Breast cancer is the most commonly diagnosed cancer worldwide,
with an estimated 2.3 million patients diagnosed in 2020. In the
European Union (EU), one in seven people who were assigned female
at birth will develop breast cancer in their lifetime.
Approximately 75% of breast cancer patients worldwide are diagnosed
with early breast cancer; however, a quarter of these patients will
experience disease recurrence following surgery. In Europe,
germline BRCA mutations are found in approximately 9% of
patients.
Professor Andrew Tutt, Global Chair of the OlympiA Phase III
trial and Professor of Oncology at The Institute of Cancer
Research, London and King’s College London, said: “For patients
with high-risk, early-stage breast cancer, the risk of recurrence
remains unacceptably high, and cancer will return for more than one
in four of these patients. Today’s recommendation is hopeful news
for patients in Europe, as we move closer to setting a potential
new standard of care that improves overall survival in patients
suitable for treatment with olaparib.”
Susan Galbraith, executive vice president, oncology R&D,
AstraZeneca, said, “If approved, LYNPARZA will provide a new
targeted treatment option for patients with germline BRCA-mutated,
HER2-negative early breast cancer in Europe. By treating patients
as early as possible in their disease, we hope to avoid
life-threatening recurrence and give people more time with their
loved ones.”
Dr. Eliav Barr, senior vice president, head of global clinical
development and chief medical officer, Merck Research Laboratories,
said, “Patients with germline BRCA-mutated, HER2-negative early
breast cancer will often develop breast cancer at an earlier age
than those without BRCA mutations, impacting people in their prime.
Today’s positive opinion brings us closer to our goal of offering a
much-needed new treatment option to these patients in Europe.”
In the trial, LYNPARZA demonstrated a statistically significant
and clinically meaningful improvement in the primary endpoint of
invasive disease-free survival (IDFS), reducing the risk of
invasive breast cancer recurrences, second cancers or death by 42%
(HR=0.58 [99.5% CI, 0.41-0.82]; p<0.0001) versus placebo.
Overall survival (OS) data presented in March 2022 at the European
Society for Medical Oncology Virtual Plenary showed LYNPARZA
demonstrated a statistically significant and clinically meaningful
improvement in the key secondary endpoint of OS, reducing the risk
of death by 32% (HR=0.68; 98.5% CI 0.47-0.97; p=0.0091) versus
placebo. The safety and tolerability profile of LYNPARZA in this
trial was in line with that observed in prior clinical trials. The
most common adverse reactions (ARs) ≥10% for LYNPARZA were nausea
(57%), fatigue (42%), anemia (24%), vomiting (23%), headache (20%),
diarrhea (18%), leukopenia (17%), neutropenia (16%), decreased
appetite (13%), dysgeusia (12%), dizziness (11%) and stomatitis
(10%). Approximately 10% of patients who received LYNPARZA
discontinued treatment due to an AR. The most common Grade ≥3 ARs
for LYNPARZA were anemia (9%), neutropenia (5%), leukopenia (3%)
and fatigue (1.8%). The safety and tolerability profile of LYNPARZA
in this trial was in line with that observed in prior clinical
trials. The most common adverse reactions (ARs) ≥10% for LYNPARZA
were nausea (57%), fatigue (42%), anemia (24%), vomiting (23%),
headache (20%), diarrhea (18%), leukopenia (17%), neutropenia
(16%), decreased appetite (13%), dysgeusia (12%), dizziness (11%)
and stomatitis (10%). Approximately 10% of patients who received
LYNPARZA discontinued treatment due to an AR. The most common Grade
≥3 ARs for LYNPARZA were anemia (9%), neutropenia (5%), leukopenia
(3%) and fatigue (1.8%).
In March 2022, LYNPARZA was approved in the U.S. for the
adjuvant treatment of patients with gBRCAm, HER2-negative high-risk
early breast based on results from the OlympiA trial. LYNPARZA is
also approved in the U.S., EU, Japan and several other countries
for the treatment of adult patients with gBRCAm, HER2-negative
metastatic breast cancer previously treated with chemotherapy and,
if hormone receptor-positive, endocrine therapy if appropriate
based on results from the Phase 3 OlympiAD trial. In the EU and
Japan, this indication also includes patients with locally advanced
breast cancer.
About OlympiA OlympiA is a Phase 3, double-blind,
parallel-group, placebo-controlled, international trial evaluating
the efficacy and safety of LYNPARZA versus placebo as adjuvant
treatment in patients with gBRCAm, HER2-negative high-risk early
breast cancer who have completed definitive local treatment and
neoadjuvant or adjuvant chemotherapy. The primary endpoint is IDFS,
defined as the time from randomization to the date of the first
loco-regional or distant recurrence or new cancer or death from any
cause. A key secondary efficacy outcome measure is OS.
The OlympiA trial is led by BIG in partnership with the Frontier
Science & Technology Research Foundation, NRG Oncology,
AstraZeneca and Merck.
IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS There are
no contraindications for LYNPARZA.
WARNINGS AND PRECAUTIONS Myelodysplastic Syndrome/Acute
Myeloid Leukemia (MDS/AML): Occurred in approximately 1.5% of
patients exposed to LYNPARZA monotherapy, and the majority of
events had a fatal outcome. The median duration of therapy in
patients who developed MDS/AML was 2 years (range: <6 months to
>10 years). All of these patients had previous chemotherapy with
platinum agents and/or other DNA-damaging agents, including
radiotherapy.
Do not start LYNPARZA until patients have recovered from
hematological toxicity caused by previous chemotherapy (≤Grade 1).
Monitor complete blood count for cytopenia at baseline and monthly
thereafter for clinically significant changes during treatment. For
prolonged hematological toxicities, interrupt LYNPARZA and monitor
blood count weekly until recovery.
If the levels have not recovered to Grade 1 or less after 4
weeks, refer the patient to a hematologist for further
investigations, including bone marrow analysis and blood sample for
cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.
Pneumonitis: Occurred in 0.8% of patients exposed to
LYNPARZA monotherapy, and some cases were fatal. If patients
present with new or worsening respiratory symptoms such as dyspnea,
cough, and fever, or a radiological abnormality occurs, interrupt
LYNPARZA treatment and initiate prompt investigation. Discontinue
LYNPARZA if pneumonitis is confirmed and treat patient
appropriately.
Embryo-Fetal Toxicity: Based on its mechanism of action
and findings in animals, LYNPARZA can cause fetal harm. A pregnancy
test is recommended for females of reproductive potential prior to
initiating treatment.
Females Advise females of reproductive potential of the
potential risk to a fetus and to use effective contraception during
treatment and for 6 months following the last dose.
Males Advise male patients with female partners of reproductive
potential or who are pregnant to use effective contraception during
treatment and for 3 months following the last dose of LYNPARZA and
to not donate sperm during this time.
Venous Thromboembolic Events: Including pulmonary
embolism, occurred in 7% of patients with metastatic
castration-resistant prostate cancer who received LYNPARZA plus
androgen deprivation therapy (ADT) compared to 3.1% of patients
receiving enzalutamide or abiraterone plus ADT in the PROfound
study. Patients receiving LYNPARZA and ADT had a 6% incidence of
pulmonary embolism compared to 0.8% of patients treated with ADT
plus either enzalutamide or abiraterone. Monitor patients for signs
and symptoms of venous thrombosis and pulmonary embolism, and treat
as medically appropriate, which may include long-term
anticoagulation as clinically indicated.
ADVERSE REACTIONS—First-Line Maintenance BRCAm Advanced
Ovarian Cancer Most common adverse reactions (Grades 1-4) in
≥10% of patients who received LYNPARZA in the first-line
maintenance setting for SOLO-1 were: nausea (77%),
fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%),
diarrhea (37%), constipation (28%), upper respiratory tract
infection/influenza/nasopharyngitis/bronchitis (28%), dysgeusia
(26%), decreased appetite (20%), dizziness (20%), neutropenia
(17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), urinary
tract infection (13%), thrombocytopenia (11%), and stomatitis
(11%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients who received LYNPARZA in the first-line maintenance
setting for SOLO-1 were: decrease in hemoglobin (87%), increase
in mean corpuscular volume (87%), decrease in leukocytes (70%),
decrease in lymphocytes (67%), decrease in absolute neutrophil
count (51%), decrease in platelets (35%), and increase in serum
creatinine (34%).
ADVERSE REACTIONS—First-Line Maintenance Advanced Ovarian
Cancer in Combination with Bevacizumab Most common adverse
reactions (Grades 1-4) in ≥10% of patients treated with
LYNPARZA/bevacizumab compared to a ≥5% frequency for
placebo/bevacizumab in the first-line maintenance setting
for PAOLA-1 were: nausea (53%), fatigue (including asthenia)
(53%), anemia (41%), lymphopenia (24%), vomiting (22%) and
leukopenia (18%). In addition, the most common adverse reactions
(≥10%) for patients receiving LYNPARZA/bevacizumab irrespective of
the frequency compared with the placebo/bevacizumab arm were:
diarrhea (18%), neutropenia (18%), urinary tract infection (15%)
and headache (14%).
In addition, venous thromboembolic events occurred more commonly
in patients receiving LYNPARZA/bevacizumab (5%) than in those
receiving placebo/bevacizumab (1.9%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients for LYNPARZA in combination with bevacizumab in the
first-line maintenance setting for PAOLA-1 were:
decrease in hemoglobin (79%), decrease in lymphocytes (63%),
increase in serum creatinine (61%), decrease in leukocytes (59%),
decrease in absolute neutrophil count (35%) and decrease in
platelets (35%).
ADVERSE REACTIONS—Maintenance Recurrent Ovarian
Cancer
Most common adverse reactions (Grades 1-4) in ≥20% of patients
who received LYNPARZA in the maintenance setting for
SOLO-2 were: nausea (76%), fatigue (including asthenia)
(66%), anemia (44%), vomiting (37%), nasopharyngitis/upper
respiratory tract infection (URI)/influenza (36%), diarrhea (33%),
arthralgia/myalgia (30%), dysgeusia (27%), headache (26%),
decreased appetite (22%), and stomatitis (20%).
Study 19: nausea (71%), fatigue (including asthenia)
(63%), vomiting (35%), diarrhea (28%), anemia (23%), respiratory
tract infection (22%), constipation (22%), headache (21%),
decreased appetite (21%) and dyspepsia (20%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients who received LYNPARZA in the maintenance setting
(SOLO-2/Study 19) were: increase in mean corpuscular volume
(89%/82%), decrease in hemoglobin (83%/82%), decrease in leukocytes
(69%/58%), decrease in lymphocytes (67%/52%), decrease in absolute
neutrophil count (51%/47%), increase in serum creatinine (44%/45%),
and decrease in platelets (42%/36%).
ADVERSE REACTIONS—Advanced gBRCAm Ovarian Cancer After 3 or
More Lines of Chemotherapy Most common adverse reactions
(Grades 1-4) in ≥20% of patients who received LYNPARZA for
advanced gBRCAm ovarian cancer after 3 or more lines of
chemotherapy (pooled from 6 studies) were: fatigue/asthenia
(66%), nausea (64%), vomiting (43%), anemia (34%), diarrhea (31%),
nasopharyngitis/upper respiratory tract infection (URI) (26%),
dyspepsia (25%), myalgia (22%), decreased appetite (22%), and
arthralgia/musculoskeletal pain (21%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients who received LYNPARZA for advanced gBRCAm ovarian
cancer (pooled from 6 studies) were: decrease in hemoglobin
(90%), mean corpuscular volume elevation (57%), decrease in
lymphocytes (56%), increase in serum creatinine (30%), decrease in
platelets (30%), and decrease in absolute neutrophil count
(25%).
ADVERSE REACTIONS—Adjuvant Treatment of gBRCAm,
HER2-Negative, High-Risk Early Breast Cancer Most common
adverse reactions (Grades 1-4) in ≥10% of patients who received
LYNPARZA in the adjuvant setting for OlympiA were:
nausea (57%), fatigue (including asthenia) (42%), anemia (24%),
vomiting (23%), headache (20%), diarrhea (18%), leukopenia (17%),
neutropenia (16%), decreased appetite (13%), dysgeusia (12%),
dizziness (11%), and stomatitis (10%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients who received LYNPARZA in the adjuvant setting for
OlympiA were: decrease in lymphocytes (77%), increase in
mean corpuscular volume (67%), decrease in hemoglobin (65%),
decrease in leukocytes (64%), and decrease in absolute neutrophil
count (39%).
ADVERSE REACTIONS—gBRCAm, HER2-Negative Metastatic Breast
Cancer Most common adverse reactions (Grades 1-4) in ≥20% of
patients who received LYNPARZA in the metastatic setting for
OlympiAD were: nausea (58%), anemia (40%), fatigue
(including asthenia) (37%), vomiting (30%), neutropenia (27%),
respiratory tract infection (27%), leukopenia (25%), diarrhea
(21%), and headache (20%).
Most common laboratory abnormalities (Grades 1-4) in
>25% of patients who received
LYNPARZA in the metastatic setting for OlympiAD were:
decrease in hemoglobin (82%), decrease in lymphocytes (73%),
decrease in leukocytes (71%), increase in mean corpuscular volume
(71%), decrease in absolute neutrophil count (46%), and decrease in
platelets (33%).
ADVERSE REACTIONS—First-Line Maintenance gBRCAm Metastatic
Pancreatic Adenocarcinoma Most common adverse reactions (Grades
1-4) in ≥10% of patients who received LYNPARZA in the first-line
maintenance setting for POLO were: fatigue (60%), nausea
(45%), abdominal pain (34%), diarrhea (29%), anemia (27%),
decreased appetite (25%), constipation (23%), vomiting (20%), back
pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%),
dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia
(11%), and stomatitis (10%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients who received LYNPARZA in the first-line maintenance
setting for POLO were: increase in serum creatinine
(99%), decrease in hemoglobin (86%), increase in mean corpuscular
volume (71%), decrease in lymphocytes (61%), decrease in platelets
(56%), decrease in leukocytes (50%), and decrease in absolute
neutrophil count (25%).
ADVERSE REACTIONS—HRR Gene-mutated Metastatic Castration
Resistant Prostate Cancer Most common adverse reactions (Grades
1-4) in ≥10% of patients who received LYNPARZA for PROfound
were: anemia (46%), fatigue (including asthenia) (41%), nausea
(41%), decreased appetite (30%), diarrhea (21%), vomiting (18%),
thrombocytopenia (12%), cough (11%), and dyspnea (10%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients who received LYNPARZA for PROfound were: decrease
in hemoglobin (98%), decrease in lymphocytes (62%), decrease in
leukocytes (53%), and decrease in absolute neutrophil count
(34%).
DRUG INTERACTIONS Anticancer Agents: Clinical studies of
LYNPARZA with other myelosuppressive anticancer agents, including
DNA-damaging agents, indicate a potentiation and prolongation of
myelosuppressive toxicity.
CYP3A Inhibitors: Avoid coadministration of strong or
moderate CYP3A inhibitors when using LYNPARZA. If a strong or
moderate CYP3A inhibitor must be coadministered, reduce the dose of
LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice,
Seville oranges, and Seville orange juice during LYNPARZA
treatment.
CYP3A Inducers: Avoid coadministration of strong or
moderate CYP3A inducers when using LYNPARZA.
USE IN SPECIFIC POPULATIONS Lactation: No data are
available regarding the presence of olaparib in human milk, its
effects on the breastfed infant or on milk production. Because of
the potential for serious adverse reactions in the breastfed
infant, advise a lactating woman not to breastfeed during treatment
with LYNPARZA and for 1 month after receiving the final dose.
Pediatric Use: The safety and efficacy of LYNPARZA have
not been established in pediatric patients.
Hepatic Impairment: No adjustment to the starting dose is
required in patients with mild or moderate hepatic impairment
(Child-Pugh classification A and B). There are no data in patients
with severe hepatic impairment (Child-Pugh classification C).
Renal Impairment: No dosage modification is recommended
in patients with mild renal impairment (CLcr 51-80 mL/min estimated
by Cockcroft-Gault). In patients with moderate renal impairment
(CLcr 31-50 mL/min), reduce the dose of LYNPARZA to 200 mg twice
daily. There are no data in patients with severe renal impairment
or end-stage renal disease (CLcr ≤30 mL/min).
INDICATIONS for LYNPARZA in the United States LYNPARZA is
a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for:
First-Line Maintenance BRCAm Advanced Ovarian Cancer For
the maintenance treatment of adult patients with deleterious or
suspected deleterious germline or somatic BRCA-mutated (gBRCAm or
sBRCAm) advanced epithelial ovarian, fallopian tube or primary
peritoneal cancer who are in complete or partial response to
first-line platinum-based chemotherapy. Select patients for therapy
based on an FDA-approved companion diagnostic for LYNPARZA.
First-Line Maintenance HRD-Positive Advanced Ovarian Cancer
in Combination with Bevacizumab In combination with bevacizumab
for the maintenance treatment of adult patients with advanced
epithelial ovarian, fallopian tube or primary peritoneal cancer who
are in complete or partial response to first-line platinum-based
chemotherapy and whose cancer is associated with homologous
recombination deficiency (HRD) positive status defined by
either:
- a deleterious or suspected deleterious BRCA mutation
and/or
- genomic instability
Select patients for therapy based on an FDA-approved companion
diagnostic for LYNPARZA.
Maintenance Recurrent Ovarian Cancer For the maintenance
treatment of adult patients with recurrent epithelial ovarian,
fallopian tube, or primary peritoneal cancer, who are in complete
or partial response to platinum-based chemotherapy.
Advanced gBRCAm Ovarian Cancer For the treatment of adult
patients with deleterious or suspected deleterious germline
BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated
with 3 or more prior lines of chemotherapy. Select patients for
therapy based on an FDA-approved companion diagnostic for
LYNPARZA.
Adjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early
Breast Cancer For the adjuvant treatment of adult patients with
deleterious or suspected deleterious gBRCAm, human epidermal growth
factor receptor 2 (HER2)-negative high-risk early breast cancer who
have been treated with neoadjuvant or adjuvant chemotherapy. Select
patients for therapy based on an FDA-approved companion diagnostic
for LYNPARZA.
gBRCAm HER2-Negative Metastatic Breast Cancer For the
treatment of adult patients with deleterious or suspected
deleterious gBRCAm, human epidermal growth factor receptor 2
(HER2)-negative metastatic breast cancer, who have been treated
with chemotherapy in the neoadjuvant, adjuvant or metastatic
setting. Patients with hormone receptor (HR)-positive breast cancer
should have been treated with a prior endocrine therapy or be
considered inappropriate for endocrine therapy. Select patients for
therapy based on an FDA-approved companion diagnostic for
LYNPARZA.
First-Line Maintenance gBRCAm Metastatic Pancreatic
Cancer For the maintenance treatment of adult patients with
deleterious or suspected deleterious gBRCAm metastatic pancreatic
adenocarcinoma whose disease has not progressed on at least 16
weeks of a first-line platinum-based chemotherapy regimen. Select
patients for therapy based on an FDA-approved companion diagnostic
for LYNPARZA.
HRR Gene-mutated Metastatic Castration Resistant Prostate
Cancer For the treatment of adult patients with deleterious or
suspected deleterious germline or somatic homologous recombination
repair (HRR) gene-mutated metastatic castration-resistant prostate
cancer (mCRPC) who have progressed following prior treatment with
enzalutamide or abiraterone. Select patients for therapy based on
an FDA-approved companion diagnostic for LYNPARZA.
Please see complete Prescribing Information, including
Medication Guide.
About LYNPARZA® (olaparib) LYNPARZA is a first-in-class
PARP inhibitor and the first targeted treatment to potentially
exploit DNA damage response (DDR) pathway deficiencies, such as
BRCA mutations, to preferentially kill cancer cells. Inhibition of
PARP with LYNPARZA leads to the trapping of PARP bound to DNA
single-strand breaks, stalling of replication forks, their collapse
and the generation of DNA double-strand breaks and cancer cell
death. LYNPARZA is being tested in a range of tumor types with
defects and dependencies in the DDR.
LYNPARZA, which is being jointly developed and commercialized by
AstraZeneca and Merck, has a broad and advanced clinical trial
development program, and AstraZeneca and Merck are working together
to understand how it may affect multiple PARP-dependent tumors as a
monotherapy and in combination across multiple cancer types.
About breast cancer Early breast cancer is defined as
disease confined to the breast with or without regional lymph node
involvement and the absence of distant metastatic disease. For
women in the U.S., the five-year survival is 99% for localized
breast cancer (cancer that is found only in the breast area) and
86% for regional breast cancer (cancer that has spread outside the
breast to nearby structures or lymph nodes). Breast cancer is one
of the most biologically diverse tumor types with various factors
fueling its development and progression. The discovery of
biomarkers in the development of breast cancer has greatly impacted
scientific understanding of the disease.
About BRCA mutations BRCA1 and BRCA2 (breast cancer
susceptibility genes 1/2) are human genes that produce proteins
responsible for repairing damaged DNA and play an important role
maintaining the genetic stability of cells. When either of these
genes is mutated or altered such that its protein product either is
not made or does not function correctly, DNA damage may not be
repaired properly, and cells become unstable. As a result, cells
are more likely to develop additional genetic alterations that can
lead to cancer.
About the AstraZeneca and Merck strategic oncology
collaboration In July 2017, AstraZeneca and Merck, known as MSD
outside the United States and Canada, announced a global strategic
oncology collaboration to co-develop and co-commercialize certain
oncology products including LYNPARZA, the world’s first PARP
inhibitor, for multiple cancer types. Working together, the
companies will develop these products in combination with other
potential new medicines and as monotherapies. Independently, the
companies will develop these oncology products in combination with
their respective PD-L1 and PD-1 medicines.
Merck’s focus on cancer Our goal is to translate breakthrough
science into innovative oncology medicines to help people with
cancer worldwide. At Merck, the potential to bring new hope to
people with cancer drives our purpose and supporting accessibility
to our cancer medicines is our commitment. As part of our focus on
cancer, Merck is committed to exploring the potential of
immuno-oncology with one of the largest development programs in the
industry across more than 30 tumor types. We also continue to
strengthen our portfolio through strategic acquisitions and are
prioritizing the development of several promising oncology
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 At Merck, known as MSD outside of the United
States and Canada, we are unified around our purpose: We use the
power of leading-edge science to save and improve lives around the
world. For more than 130 years, we have brought hope to humanity
through the development of important medicines and vaccines. We
aspire to be the premier research-intensive biopharmaceutical
company in the world – and today, we are at the forefront of
research to deliver innovative health solutions that advance the
prevention and treatment of diseases in people and animals. We
foster a diverse and inclusive global workforce and operate
responsibly every day to enable a safe, sustainable and healthy
future for all people and communities. For more information, visit
www.merck.com and connect with us on Twitter, Facebook, Instagram,
YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway,
N.J., USA This news release of Merck & Co., Inc., Rahway,
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
candidates that the candidates 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 the global outbreak of novel coronavirus disease
(COVID-19); 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 Annual
Report on Form 10-K for the year ended December 31, 2021 and the
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