THOUSAND OAKS, Calif.,
Aug. 21, 2017 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced that new data from
the Repatha® (evolocumab) clinical trial program,
including three late-breaking scientific sessions, will be
presented at the European Society of Cardiology (ESC) Congress 2017
in Barcelona, Spain, Aug. 26-30, 2017. New data includes additional
efficacy and safety analyses from the Repatha cardiovascular
outcomes trial (FOURIER) and the Repatha coronary intravascular
ultrasound imaging trial (GLAGOV).
"Data from the Repatha clinical trial program continue to
reinforce the value of this innovative medicine for patients at
risk of a heart attack or stroke," said Sean E. Harper, M.D., executive vice president
of Research and Development at Amgen. "We look forward to sharing
the breadth of data demonstrating Repatha's ability to lower LDL
cholesterol and reduce cardiovascular events, including the effect
of Repatha in patients with a history of stroke."
Data from the Repatha cardiovascular outcomes trial assessing
the effect of Repatha on cardiovascular outcomes in patients with a
history of stroke will be presented in a late-breaking science
session (Clinical Trial Update 2) along with a new analysis from
the GLAGOV trial. A second analysis of the Repatha
cardiovascular outcomes trial, assessing the efficacy and safety of
achieving very low low-density lipoprotein cholesterol (LDL-C)
levels with Repatha, will be presented in the late-breaking
Clinical Trial Update 1 session.
Amgen-sponsored abstracts at ESC Congress 2017 include:
Repatha
Clinical
Late-Breaking Science Sessions
- Clinical Efficacy and Safety of Achieving Very Low LDL-C
Levels With the PCSK9 Inhibitor Evolocumab in the FOURIER Outcomes
Trial
Clinical Trial Update 1, Monday, Aug. 28, 2:30 – 2:45 p.m. CEST
- Effect of the PCSK9 Inhibitor, Evolocumab, on the
Composition of Coronary Atherosclerosis: Insights on the GLAGOV
Trial
Clinical Trial Update 2, Tuesday, Aug. 29, 4:45 – 5 p.m. CEST
- Further Cardiovascular OUtcomes Research With PCSK9
Inhibition in Subjects With Elevated Risk (Focus on Cerebrovascular
Disease)
Clinical Trial Update 2, Tuesday, Aug. 29, 5 – 5:15
p.m. CEST
Poster Sessions
- Efficacy and Safety of Evolocumab Compared With Continued
Lipoprotein Apheresis: Results of a Randomised, Controlled,
Open-Label Study
Late-Breaking Science Posters,
Sunday, Aug. 27, 8:30 a.m. – 6 p.m.
CEST
Moderated Session, 3:35 – 4:25 p.m.
CEST
- Evolocumab Treatment in Paediatric Patients With Homozygous
Familial Hypercholesterolaemia: the Trial Assessing Long-Term Use
of PCSK9 Inhibition in Subjects With Genetic LDL Disorders
(TAUSSIG)
Rapid Fire Session, Lipid Lowering Therapy in
Primary Cardiovascular Prevention, Monday,
Aug. 28, 12:12 – 12:21 p.m.
CEST
- Evolocumab Lowers Plasma Lp(a) Concentration by Two Kinetic
Modes of Action: From the FLOREY Study
Lipid Metabolism,
Monday, Aug. 28, 8:30 a.m. – 12:30 p.m.
CEST
Moderated Session: 10:05 – 10:55 a.m.
CEST
- Is Lipoprotein(a) Metabolism Linked to the Transport and
Catabolic Rates of Apolipoprotein B-100 Containing
Lipoproteins?
Lipid Metabolism, Monday, Aug. 28, 8:30
a.m. – 12:30 p.m. CEST
Moderated Session: 10:05 – 10:55 a.m.
CEST
Observational Research
- Changes in Lipid-lowering Therapy Prescription Patterns
Following a Second Cardiovascular Disease
Event
Lipid-lowering Therapy: Old Faces and New Issues,
Saturday, Aug. 26, 11 a.m. – 4 p.m.
CEST
Moderated Session, 12:35 – 1:25 p.m.
CEST
- Evaluation of Statin Users, People With
Hypercholesterolemia, and Cardiovascular Disease Patients in the
Japan Medical Data Center Claims Database
Poster Session 1:
Treatment of Dyslipidaemia, Saturday, Aug.
26, 11 a.m. – 4 p.m. CEST
- Statin Use Among HIV-Infected Adults by Cardiovascular
Disease Risk Status
Lipid-lowering Therapy: Old Faces and
New Issues, Saturday, Aug. 26,
11 a.m. – 4
p.m. CEST
Moderated Session, 12:35 – 1:25 p.m.
CEST
- Adherence to Intensive Medical Management in the Year
Following Hospitalization for Myocardial Infarction
Poster
Session 5: Prevention – Epidemiology, Monday, Aug. 28, 2 – 6
p.m. CEST
- Characterizing Familial Hypercholesterolemia in an
Electronic Health Record (EHR) Database
Poster Session 6:
Lipids, Obesity and Metabolic Syndrome, Tuesday, Aug. 29, 8:30
a.m. – 12:30 p.m. CEST
Health Economics
- Lack of Low-Density Lipoprotein Cholesterol (LDL-C) Goal
Attainment Among High-Risk Patients Using High or Moderate
Intensity Statin Therapy in Germany
Best Posters 3: Best Posters in
New Targets in Cardiovascular Drug Assessment, Sunday, Aug. 27, 2 – 6
p.m. CEST
Discussant Review, 3:35 – 4:25 p.m.
CEST
Corlanor® (ivabradine)
Observational Research
- Increased Heart Rate is Independently Associated With Worse
Survival in Pediatric Patients with Dilated Cardiomyopathy: a
Multicenter Study From the Pediatric Cardiomyopathy
Registry
Contemporary Management of Risk Factors in
Congenital Heart Disease, Sunday, Aug.
27, 8:57 - 9:06 a.m. CEST
Repatha Cardiovascular Outcomes (FOURIER) Study
Design
The 27,564-patient Repatha cardiovascular outcomes
study, FOURIER (Further Cardiovascular OUtcomes Research
with PCSK9 Inhibition in Subjects
with Elevated Risk), was a multinational Phase 3
randomized, double-blind, placebo-controlled trial, designed to
evaluate whether treatment with Repatha in combination with statin
therapy compared to placebo plus statin therapy reduces
cardiovascular events. The primary endpoint was time to
cardiovascular death, myocardial infarction, stroke,
hospitalization for unstable angina, or coronary revascularization.
The key secondary endpoint was the time to cardiovascular death,
myocardial infarction or stroke.
Eligible patients with high cholesterol (LDL-C ≥70 mg/dL or
non-high-density lipoprotein cholesterol [non-HDL-C] ≥100 mg/dL)
and clinically evident atherosclerotic cardiovascular disease at
more than 1,200 study locations around the world were randomized to
receive Repatha subcutaneous 140 mg every two weeks or 420 mg
monthly plus optimized statin dose; or placebo subcutaneous every
two weeks or monthly plus optimized statin dose. Optimized statin
therapy was defined as at least atorvastatin 20 mg or equivalent
daily with a recommendation for at least atorvastatin 40 mg or
equivalent daily where approved. The study was event driven and
continued until 1,630 patients experienced a key secondary
endpoint.
GLAGOV Study Design
GLAGOV (GLobal Assessment of
Plaque ReGression with a PCSK9 AntibOdy as Measured by
IntraVascular Ultrasound) is a Phase 3, multicenter, double-blind,
randomized, placebo-controlled trial designed to evaluate the
effect of Repatha on the change in burden of coronary artery
disease (CAD) in 968 patients undergoing clinically indicated
coronary angiogram and on optimized background statin therapy.
Patients were required to have been treated with a stable statin
dose for at least four weeks and to have a LDL-C ≥80 mg/dL or
between 60 and 80 mg/dL with one major cardiovascular risk factor
(defined as non-coronary atherosclerotic vascular disease,
myocardial infarction or hospitalization for unstable angina in the
preceding two years or type 2 diabetes mellitus) or three minor
cardiovascular risk factors (defined as current cigarette smoking,
hypertension, low levels of HDL cholesterol, family history of
premature coronary heart disease, high sensitivity C-reactive
protein (hs-CRP) ≥2 mg/L or age ≥50 years in men and 55 years in
women).
Patients were randomized 1:1 into two treatment groups to either
receive monthly Repatha 420 mg or placebo subcutaneous injections.
Optimized statin therapy was defined as at least atorvastatin 20 mg
daily or equivalent, titrated to achieve LDL-C reduction per
regional guidelines. Highly effective statin therapy (equivalent to
atorvastatin 40 mg daily or higher) was recommended for all
patients. Those patients with LDL-C >100 mg/dL not taking highly
effective statin therapy, required investigators' attestation as to
why such doses were not appropriate. The primary endpoint was
change in percent atheroma volume (PAV) from baseline to week 78
compared to placebo, as determined by intravascular ultrasound
(IVUS). IVUS is a high-resolution imaging tool that allows for the
quantification of coronary atheroma in the coronary arteries.
Secondary endpoints included PAV regression (any reduction from
baseline); change in total atheroma volume (TAV) from baseline to
week 78; and regression (any reduction from baseline) in TAV.
About
Repatha® (evolocumab)
Repatha® (evolocumab)
is a human monoclonal antibody that inhibits proprotein convertase
subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and
inhibits circulating PCSK9 from binding to the low-density
lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR
degradation and permitting LDLR to recycle back to the liver cell
surface. By inhibiting the binding of PCSK9 to LDLR, Repatha
increases the number of LDLRs available to clear LDL from the
blood, thereby lowering LDL-C levels.1
Repatha is approved in more than 50 countries, including the
U.S., Japan, Canada and in all 28 countries that are
members of the European Union. Applications in other countries
are pending.
U.S. Repatha Indication
Repatha® is
indicated as an adjunct to diet and:
- Maximally tolerated statin therapy for treatment of adults with
heterozygous familial hypercholesterolemia (HeFH) or clinical
atherosclerotic cardiovascular disease (ASCVD), who require
additional lowering of low-density lipoprotein cholesterol
(LDL-C)
- Other LDL-lowering therapies (e.g., statins, ezetimibe, LDL
apheresis) in patients with homozygous familial
hypercholesterolemia (HoFH) who require additional lowering of
LDL-C
The effect of Repatha® on cardiovascular
morbidity and mortality has not been determined.
The safety and effectiveness of Repatha® have
not been established in pediatric patients with HoFH who are
younger than 13 years old.
The safety and effectiveness of Repatha® have
not been established in pediatric patients with primary
hyperlipidemia or HeFH.
Important U.S. Safety
Information
Contraindication: Repatha® is
contraindicated in patients with a history of a serious
hypersensitivity reaction to Repatha®.
Allergic reactions: Hypersensitivity reactions (e.g.
rash, urticaria) have been reported in patients treated with
Repatha®, including some that led to discontinuation of
therapy. If signs or symptoms of serious allergic reactions occur,
discontinue treatment with Repatha®, treat according to
the standard of care, and monitor until signs and symptoms
resolve.
Adverse reactions: The most common adverse reactions
(>5% of Repatha®-treated patients and more common
than placebo) were: nasopharyngitis, upper respiratory tract
infection, influenza, back pain, and injection site reactions.
In a 52-week trial, adverse reactions led to discontinuation of
treatment in 2.2% of Repatha®-treated patients and 1% of
placebo-treated patients. The most common adverse reaction that led
to Repatha® treatment discontinuation and occurred
at a rate greater than placebo was myalgia (0.3% versus 0% for
Repatha® and placebo, respectively).
Adverse reactions from a pool of the 52-week trial and seven
12-week trials: Local injection site reactions occurred in 3.2% and
3.0% of Repatha®-treated and placebo-treated patients,
respectively. The most common injection site reactions were
erythema, pain, and bruising. The proportions of patients who
discontinued treatment due to local injection site reactions in
Repatha®-treated patients and placebo-treated patients
were 0.1% and 0%, respectively.
Allergic reactions occurred in 5.1% and 4.7% of
Repatha®-treated and placebo-treated patients,
respectively. The most common allergic reactions were rash (1.0%
versus 0.5% for Repatha® and placebo,
respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus
0.2%), and urticaria (0.4% versus 0.1%).
Neurocognitive events were reported in less than or equal to
0.2% in Repatha®-treated and placebo-treated
patients.
In a pool of placebo- and active-controlled trials, as well as
open-label extension studies that followed them, a total of 1,988
patients treated with Repatha® had at least one
LDL-C value <25 mg/dL. Changes to background lipid-altering
therapy were not made in response to low LDL-C values, and
Repatha® dosing was not modified or interrupted on
this basis. Although adverse consequences of very low LDL-C were
not identified in these trials, the long-term effects of very low
levels of LDL-C induced by Repatha® are
unknown.
Musculoskeletal adverse reactions were reported in 14.3% of
Repatha®-treated patients and 12.8% of placebo-treated
patients. The most common adverse reactions that occurred at a rate
greater than placebo were back pain (3.2% versus 2.9% for
Repatha® and placebo, respectively), arthralgia
(2.3% versus 2.2%), and myalgia (2.0% versus 1.8%).
Homozygous Familial Hypercholesterolemia (HoFH): In
49 patients with homozygous familial hypercholesterolemia studied
in a 12-week, double-blind, randomized, placebo-controlled trial,
33 patients received 420 mg of
Repatha® subcutaneously once monthly. The adverse
reactions that occurred in at least 2 (6.1%)
Repatha®-treated patients and more frequently than in
placebo-treated patients, included upper respiratory tract
infection (9.1% versus 6.3%), influenza (9.1% versus 0%),
gastroenteritis (6.1% versus 0%), and nasopharyngitis (6.1% versus
0%).
Immunogenicity: Repatha® is a human
monoclonal antibody. As with all therapeutic proteins, there is a
potential for immunogenicity with Repatha®.
Please contact Amgen Medinfo at 800-77-AMGEN (800-772-6436)
or 844-REPATHA (844-737-2842) regarding
Repatha® availability or find more information,
including full Prescribing Information,
at www.amgen.com and www.Repatha.com.
Important EU Product Information
In Europe Repatha is
approved for use in:
Hypercholesterolemia and mixed dyslipidemia
Repatha is
indicated in adults with primary hypercholesterolemia (heterozygous
familial and non-familial) or mixed dyslipidemia, as an adjunct to
diet:
- in combination with a statin or statin with other lipid
lowering therapies in patients unable to reach LDL-C goals with the
maximum tolerated dose of a statin or,
- alone or in combination with other lipid-lowering therapies in
patients who are statin-intolerant, or for whom a statin is
contraindicated.
Homozygous familial hypercholesterolemia
Repatha is
indicated in adults and adolescents aged 12 years and over with
homozygous familial hypercholesterolemia in combination with other
lipid-lowering therapies.
The effect of Repatha on cardiovascular morbidity and mortality
has not yet been determined.
Posology
Primary hypercholesterolemia and mixed dyslipidemia in
adults
The recommended dose of Repatha is either 140 mg
every two weeks or 420 mg once monthly; both doses are clinically
equivalent.
Homozygous familial hypercholesterolemia in adults and
adolescents aged 12 years and over
The initial recommended
dose is 420 mg once monthly. After 12 weeks of treatment, dose
frequency can be up-titrated to 420 mg once every 2 weeks if a
clinically meaningful response is not achieved. Patients on
apheresis may initiate treatment with 420 mg every two weeks to
correspond with their apheresis schedule.
Important Safety Information
This medicinal product is
subject to additional monitoring. This will allow quick
identification of new safety information. Healthcare professionals
are asked to report any suspected adverse reactions.
Contraindications: Hypersensitivity to the active
substance or to any of the excipients.
Special Warnings and Precautions: Renal
impairment: Patients with severe renal impairment (defined as
eGFR < 30 mL/min/1.73 m2) have not been
studied. Repatha should be used with caution in patients with
severe renal impairment. Hepatic impairment: In patients
with moderate hepatic impairment, a reduction in total evolocumab
exposure was observed that may lead to a reduced effect on LDL‑C
reduction. Therefore, close monitoring may be warranted in these
patients. Patients with severe hepatic impairment (Child-Pugh C)
have not been studied. Repatha should be used with caution in
patients with severe hepatic impairment. Dry natural
rubber: The needle cover of the glass pre-filled syringe and
of the pre-filled pen is made from dry natural rubber (a derivative
of latex), which may cause allergic reactions. Sodium
content: Repatha contains less than 1 mmol sodium (23 mg) per
dose, i.e. it is essentially 'sodium-free'.
Interactions: No formal drug-drug interaction
studies have been conducted for Repatha. No studies on
pharmacokinetic and pharmacodynamics interaction between Repatha
and lipid-lowering drugs other than statins and ezetimibe have been
conducted.
Fertility, Pregnancy and Lactation: There are no or
limited amount of data from the use of Repatha in pregnant women.
Repatha should not be used during pregnancy unless the clinical
condition of the woman requires treatment with evolocumab. It is
unknown whether evolocumab is excreted in human milk. A risk to
breastfed newborns/infants cannot be excluded. No data on the
effect of evolocumab on human fertility are
available.
Undesirable Effects: The following common
(> 1/100 to < 1/10) adverse reactions have been reported
in pivotal, controlled clinical studies: influenza,
nasopharyngitis, upper respiratory tract infection, rash, nausea,
back pain, arthralgia, injection site reactions. Please consult
the SmPC for a full description of undesirable
effects.
Pharmaceutical Precautions: Store in a refrigerator
(2 degrees C – 8 degrees C). Do not freeze. Keep the
pre-filled syringe or the pre-filled pen in the original carton in
order to protect from light. If removed from the refrigerator,
Repatha may be stored at room temperature (up to 25 degrees C) in
the original carton and must be used within 1 month.
About
Corlanor® (ivabradine)
Corlanor® (ivabradine)
blocks the hyperpolarization-activated cyclic nucleotide-gated
(HCN) channel responsible for the cardiac pacemaker, which
regulates heart rate. Corlanor reduces the spontaneous pacemaker
activity of the cardiac sinus node by selectively inhibiting
the If current ("funny" current) to
slow the heart rate with no effect on ventricular repolarization
and no effects on myocardial
contractility.2 Corlanor was developed by Servier.
Through a collaboration with Servier, Amgen has rights to
commercialize Corlanor in the U.S.
U.S. Corlanor
Indication:
Corlanor® is
indicated to reduce the risk of hospitalization for worsening heart
failure in patients with stable, symptomatic chronic heart failure
with left ventricular ejection fraction < 35%, who are
in sinus rhythm with resting heart rate > 70 beats per
minute (bpm) and either are on maximally tolerated doses of beta
blockers or have a contraindication to beta blocker use.
Important U.S. Safety
Information
Contraindications: Corlanor® is
contraindicated in patients with acute decompensated heart failure,
blood pressure < 90/50 mmHg, sick sinus syndrome, sinoatrial
block, 3rd degree atrioventricular (AV) block
(unless a functioning demand pacemaker is present), a resting heart
rate < 60 bpm prior to treatment, severe hepatic impairment,
pacemaker dependence (heart rate maintained exclusively by the
pacemaker) and concomitant use of strong cytochrome P450 3A4
(CYP3A4) inhibitors.
- Fetal Toxicity: Corlanor® may cause
fetal toxicity when administered to a pregnant woman.
- Atrial
Fibrillation: Corlanor® increases the risk
of atrial fibrillation. The rate of atrial fibrillation in patients
treated with Corlanor® compared to placebo was 5%
vs. 3.9% per patient-year, respectively.
- Bradycardia and Conduction
Disturbances: Bradycardia, sinus arrest and heart block
have occurred with Corlanor®. Bradycardia may increase
the risk of QT prolongation which may lead to severe ventricular
arrhythmias, including torsades de pointes, especially in patients
with risk factors such as use of QTc prolonging drugs.
Concurrent use of verapamil or diltiazem also increases
Corlanor® exposure and should be avoided. Avoid use
of Corlanor® in patients with
2nd degree atrioventricular block unless a
functioning demand pacemaker is present.
- Adverse Reactions: The most common adverse drug
reactions reported at least 1% more frequently with
Corlanor® than placebo and that occurred in more than 1%
of patients treated with Corlanor® were bradycardia
(10% vs. 2.2%), hypertension or increased blood pressure (8.9% vs.
7.8%), atrial fibrillation (8.3% vs. 6.6%), and luminous phenomena
(phosphenes) or visual brightness (2.8% vs. 0.5%). In postmarketing
experience, torsades de pointes has been observed.
Please contact Amgen Medinfo at 800-77-AMGEN (800-772-6436)
regarding Corlanor availability or find out more information,
including full Prescribing Information and Medication Guide
at www.amgen.com and www.Corlanor.com.
About Amgen in the Cardiovascular Therapeutic
Area
Building on more than three decades of experience in
developing biotechnology medicines for patients with serious
illnesses, Amgen is dedicated to addressing important
scientific questions to advance care and improve the lives of
patients with cardiovascular disease, the leading cause of
morbidity and mortality
worldwide.3 Amgen's research into
cardiovascular disease, and potential treatment options, is part of
a growing competency at Amgen that utilizes human
genetics to identify and validate certain drug targets. Through its
own research and development efforts, as well as
partnerships, Amgen is building a robust cardiovascular
portfolio consisting of several approved and investigational
molecules in an effort to address a number of today's important
unmet patient needs, such as high cholesterol and heart
failure.
About Amgen
Amgen is committed to
unlocking the potential of biology for patients suffering from
serious illnesses by discovering, developing, manufacturing and
delivering innovative human therapeutics. This approach begins by
using tools like advanced human genetics to unravel the
complexities of disease and understand the fundamentals of human
biology.
Amgen focuses on areas of high unmet medical need and
leverages its expertise to strive for solutions that improve health
outcomes and dramatically improve people's lives. A biotechnology
pioneer since 1980, Amgen has grown to be one of the
world's leading independent biotechnology companies, has reached
millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.
For more information, visit www.amgen.com and follow
us on www.twitter.com/amgen.
Forward-Looking Statements
This news release contains
forward-looking statements that are based on the current
expectations and beliefs of Amgen. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including estimates of revenues,
operating margins, capital expenditures, cash, other financial
metrics, expected legal, arbitration, political, regulatory or
clinical results or practices, customer and prescriber patterns or
practices, reimbursement activities and outcomes and other such
estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed
below and more fully described in the Securities and Exchange
Commission reports filed by Amgen, including our most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and current reports on Form 8-K. Unless otherwise noted,
Amgen is providing this information as of the date of this news
release and does not undertake any obligation to update any
forward-looking statements contained in this document as a result
of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project.
Discovery or identification of new product candidates or
development of new indications for existing products cannot be
guaranteed and movement from concept to product is uncertain;
consequently, there can be no guarantee that any particular product
candidate or development of a new indication for an existing
product will be successful and become a commercial product.
Further, preclinical results do not guarantee safe and effective
performance of product candidates in humans. The complexity of the
human body cannot be perfectly, or sometimes, even adequately
modeled by computer or cell culture systems or animal models. The
length of time that it takes for us to complete clinical trials and
obtain regulatory approval for product marketing has in the past
varied and we expect similar variability in the future. Even when
clinical trials are successful, regulatory authorities may question
the sufficiency for approval of the trial endpoints we have
selected. We develop product candidates internally and through
licensing collaborations, partnerships and joint ventures. Product
candidates that are derived from relationships may be subject to
disputes between the parties or may prove to be not as effective or
as safe as we may have believed at the time of entering into such
relationship. Also, we or others could identify safety, side
effects or manufacturing problems with our products, including our
devices, after they are on the market.
Our results may be affected by our ability to successfully
market both new and existing products domestically and
internationally, clinical and regulatory developments involving
current and future products, sales growth of recently launched
products, competition from other products including biosimilars,
difficulties or delays in manufacturing our products and global
economic conditions. In addition, sales of our products are
affected by pricing pressure, political and public scrutiny and
reimbursement policies imposed by third-party payers, including
governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
healthcare cost containment. Furthermore, our research, testing,
pricing, marketing and other operations are subject to extensive
regulation by domestic and foreign government regulatory
authorities. Our business may be impacted by government
investigations, litigation and product liability claims. In
addition, our business may be impacted by the adoption of new tax
legislation or exposure to additional tax liabilities. If we fail
to meet the compliance obligations in the corporate integrity
agreement between us and the U.S. government, we could become
subject to significant sanctions. Further, while we routinely
obtain patents for our products and technology, the protection
offered by our patents and patent applications may be challenged,
invalidated or circumvented by our competitors, or we may fail to
prevail in present and future intellectual property litigation. We
perform a substantial amount of our commercial manufacturing
activities at a few key facilities and also depend on third parties
for a portion of our manufacturing activities, and limits on supply
may constrain sales of certain of our current products and product
candidate development. In addition, we compete with other companies
with respect to many of our marketed products as well as for the
discovery and development of new products. Further, some raw
materials, medical devices and component parts for our products are
supplied by sole third-party suppliers. Certain of our
distributors, customers and payers have substantial purchasing
leverage in their dealings with us. The discovery of significant
problems with a product similar to one of our products that
implicate an entire class of products could have a material adverse
effect on sales of the affected products and on our business and
results of operations. Our efforts to acquire other companies or
products and to integrate the operations of companies we have
acquired may not be successful. We may not be able to access the
capital and credit markets on terms that are favorable to us, or at
all. We are increasingly dependent on information technology
systems, infrastructure and data security. Our stock price is
volatile and may be affected by a number of events. Our business
performance could affect or limit the ability of our Board of
Directors to declare a dividend or our ability to pay a dividend or
repurchase our common stock.
The scientific information discussed in this news release
relating to new indications is preliminary and investigative and is
not part of the labeling approved by the U.S. Food and Drug
Administration or European Commission for the
products. The products are not approved for the investigational
use(s) discussed in this news release, and no conclusions can or
should be drawn regarding the safety or effectiveness of the
products for these uses.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(Media)
Kristen Neese, 805-313-8267
(Media)
Arvind Sood, 805-447-1060
(Investors)
REFERENCES
- Repatha® U.S. Prescribing
Information. Amgen.
- Corlanor® U.S. Prescribing Information. Amgen.
- World Health Organization. Cardiovascular diseases (CVDs) fact
sheet. http://www.who.int/mediacentre/factsheets/fs317/en/. Accessed July
2017.
View original content with
multimedia:http://www.prnewswire.com/news-releases/amgen-to-present-new-data-from-the-repatha-evolocumab-cardiovascular-outcomes-study-at-esc-congress-2017-300506872.html
SOURCE Amgen