THOUSAND OAKS, Calif.,
Nov. 30, 2016 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced new data will be
presented at the 58th Annual Meeting and Exposition of
the American Society of Hematology (ASH), Dec. 3 – 6, 2016, in San Diego.
"The totality of data for our medicines to be presented at ASH
underscores our commitment to helping patients with the toughest
conditions through their journey," said Sean E. Harper, M.D., executive vice president
of Research and Development at Amgen. "We look forward to sharing
these studies and adding to the body of knowledge in acute
lymphoblastic leukemia, multiple myeloma and other hematologic
malignancies."
Amgen data to be presented at ASH include an oral presentation
on results from a sub-analysis of the pivotal Phase 3 TOWER study
evaluating the impact of BLINCYTO® (blinatumomab)
compared with standard of care chemotherapy on health-related
quality of life in patients with relapsed or refractory
Philadelphia chromosome-negative
(Ph-) B-cell precursor acute lymphoblastic leukemia (ALL):
- Health-Related Quality of Life (HQoL) of Blinatumomab Versus
Standard of Care (SOC) Chemotherapy in Patients With Relapsed or
Refractory Philadelphia Negative B-Cell Precursor Acute
Lymphoblastic Leukemia in a Randomized, Open-Label Phase 3 Study
(TOWER)
Abstract #222, Oral Presentation, Saturday, Dec. 3 from 4 – 5:30 p.m. PT at Marriott Marquis San Diego
Marina, Marriott Grand Ballroom, Salons 11-13
Among the abstracts related to KYPROLIS®
(carfilzomib) is a new analysis of the pivotal Phase 3 ENDEAVOR
trial that evaluates the cost-effectiveness of KYPROLIS compared to
bortezomib when used in combination with dexamethasone in patients
with relapsed or refractory multiple myeloma:
- Economic Evaluation of Carfilzomib + Dexamethasone (Kd)
Versus Bortezomib + Dexamethasone (Vd) in Relapsed or Refractory
Multiple Myeloma (R/RMM)
Abstract #3582, Poster
Presentation, Sunday, Dec. 4 from 6 –
8 p.m. PT at San Diego Convention Center, Hall GH
There will be an oral presentation on more than six years of
data from an ongoing open-label extension study of
Nplate® (romiplostim) in children with immune
thrombocytopenia (ITP):
- A Single-Arm, Open-Label, Long-Term Efficacy and Safety
Study of Subcutaneous (SC) Romiplostim in Children with Immune
Thrombocytopenia (ITP)
Abstract #869, Oral Presentation,
Monday, Dec. 5 from 2:45 –
4:15 p.m. PT at San Diego Convention Center, Room 29
Abstracts are currently available on the ASH website.
About BLINCYTO® (blinatumomab)
BLINCYTO is
a bispecific CD19-directed CD3 T-cell engager (BiTE®)
antibody construct that binds specifically to CD19 expressed on the
surface of cells of B-lineage origin and CD3 expressed on the
surface of T cells.
BLINCYTO was granted breakthrough therapy, priority review and
orphan drug designations by FDA, and is currently approved in
the United States (U.S.) for the
treatment of Ph- relapsed or refractory B-cell precursor ALL. This
indication is approved under accelerated approval. Continued
approval for this indication may be contingent upon verification of
clinical benefit in subsequent trials.
In November 2015, BLINCYTO was
granted conditional marketing authorization in the European Union
(EU) for the treatment of adults with Ph- relapsed or refractory
B-cell precursor ALL.
BLINCYTO® U.S. Product Safety
Information
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL
TOXICITIES
- Cytokine Release Syndrome (CRS), which may be
life-threatening or fatal, occurred in patients receiving
BLINCYTO®. Interrupt or discontinue BLINCYTO®
as recommended.
- Neurological toxicities, which may be severe,
life-threatening or fatal, occurred in patients receiving
BLINCYTO®. Interrupt or discontinue BLINCYTO®
as recommended.
Contraindications
BLINCYTO® is contraindicated in patients with a known
hypersensitivity to blinatumomab or to any component of the product
formulation.
Warnings and Precautions
- Cytokine Release Syndrome (CRS): CRS, which may be
life-threatening or fatal, occurred in patients receiving
BLINCYTO®. Infusion reactions have occurred and may be
clinically indistinguishable from manifestations of CRS. Closely
monitor patients for signs and symptoms of serious events such as
pyrexia, headache, nausea, asthenia, hypotension, increased alanine
aminotransferase (ALT), increased aspartate aminotransferase (AST),
increased total bilirubin (TBILI), disseminated intravascular
coagulation (DIC), capillary leak syndrome (CLS), and
hemophagocytic lymphohistiocytosis/macrophage activation syndrome
(HLH/MAS). Interrupt or discontinue BLINCYTO® as
outlined in the Prescribing Information (PI).
- Neurological Toxicities: Approximately 64% of patients
receiving BLINCYTO® in clinical trials experienced
neurological toxicities. The median time to onset of any
neurological toxicity was 4 days. The most common (≥ 10%)
manifestations of neurological toxicity were headache, tremor,
dizziness, and altered state of consciousness. Severe,
life-threatening, or fatal neurological toxicities occurred in
approximately 17% of patients, including encephalopathy,
convulsions, speech disorders, disturbances in consciousness,
confusion and disorientation, and coordination and balance
disorders. The neurological toxicity profile varied by age group.
Monitor patients for signs or symptoms and interrupt or discontinue
BLINCYTO® as outlined in the PI.
- Infections: Approximately 25% of patients receiving
BLINCYTO® experienced serious infections, some of which
were life-threatening or fatal. Administer prophylactic antibiotics
and employ surveillance testing as appropriate during treatment.
Monitor patients for signs or symptoms of infection and treat
appropriately, including interruption or discontinuation of
BLINCYTO® as needed.
- Tumor Lysis Syndrome (TLS): TLS, which may be life-threatening
or fatal, has been observed. Preventive measures, including
pretreatment nontoxic cytoreduction and on-treatment hydration,
should be used during BLINCYTO® treatment. Monitor
patients for signs and symptoms of TLS and interrupt or discontinue
BLINCYTO® as needed to manage these events.
- Neutropenia and Febrile Neutropenia, including life-threatening
cases, have been observed. Monitor appropriate laboratory
parameters during BLINCYTO® infusion and interrupt
BLINCYTO® if prolonged neutropenia occurs.
- Effects on Ability to Drive and Use Machines: Due to the
possibility of neurological events, including seizures, patients
receiving BLINCYTO® are at risk for loss of
consciousness, and should be advised against driving and engaging
in hazardous occupations or activities such as operating heavy or
potentially dangerous machinery while BLINCYTO® is being
administered.
- Elevated Liver Enzymes: Transient elevations in liver enzymes
have been associated with BLINCYTO® treatment with a
median time to onset of 3 days. In patients receiving
BLINCYTO®, although the majority of these events were
observed in the setting of CRS, some cases of elevated liver
enzymes were observed outside the setting of CRS, with a median
time to onset of 15 days. Grade 3 or greater elevations in liver
enzymes occurred in 6% of patients outside the setting of CRS and
resulted in treatment discontinuation in less than 1% of
patients. Monitor ALT, AST, gamma-glutamyl transferase (GGT),
and TBILI prior to the start of and during BLINCYTO®
treatment. BLINCYTO® treatment should be interrupted if
transaminases rise to > 5 times the upper limit of normal (ULN)
or if TBILI rises to > 3 times ULN.
- Pancreatitis: Fatal pancreatitis has been reported in patients
receiving BLINCYTO® in combination with dexamethasone in
clinical trials and the post-marketing setting. Evaluate patients
who develop signs and symptoms of pancreatitis and interrupt or
discontinue BLINCYTO® and dexamethasone as needed.
- Leukoencephalopathy: Although the clinical significance is
unknown, cranial magnetic resonance imaging (MRI) changes showing
leukoencephalopathy have been observed in patients receiving
BLINCYTO®, especially in patients previously treated
with cranial irradiation and antileukemic chemotherapy.
- Preparation and administration errors have occurred with
BLINCYTO® treatment. Follow instructions for preparation
(including admixing) and administration in the PI strictly to
minimize medication errors (including underdose and overdose).
- Immunization: Vaccination with live virus vaccines is not
recommended for at least 2 weeks prior to the start of
BLINCYTO® treatment, during treatment, and until immune
recovery following last cycle of BLINCYTO®.
Adverse Reactions
- The most common adverse reactions (≥ 20%) in the safety
population studied in clinical trials were pyrexia (66%), headache
(34%), nausea (27%), edema (26%), hypokalemia (26%), anemia (25%),
febrile neutropenia (24%), neutropenia (22%), thrombocytopenia
(20%), and abdominal pain (20%). The safety population included 225
patients weighing 45 kg or more and 57 patients weighing less than
45 kg. For some adverse reactions, there were differences in
the incidence rates by age subgroup.
- In patients weighing greater than or equal to 45 kg, serious
adverse reactions were reported in 61% of patients. The most common
serious adverse reactions (≥ 2%) included febrile neutropenia (9%),
pyrexia (6%), sepsis (5%), pneumonia (5%), device-related infection
(4%), neutropenia (3%), tremor (3%), overdose (3%), encephalopathy
(3%), infection (2%), confusion (3%) and headache (2%).
- In patients weighing less than 45 kg, serious adverse reactions
were reported in 51% of patients. The most common serious adverse
reactions (≥ 2%) included pyrexia (12%), febrile neutropenia (9%),
cytokine release syndrome (4%), convulsion (4%), device-related
infection (4%), hypoxia (4%), sepsis (4%), and overdose (4%).
Dosage and Administration Guidelines
- BLINCYTO® is administered as a continuous
intravenous infusion at a constant flow rate using an infusion pump
which should be programmable, lockable, non-elastomeric, and have
an alarm.
- It is very important that the instructions for preparation
(including admixing) and administration provided in the full
Prescribing Information are strictly followed to minimize
medication errors (including underdose and overdose).
Please see full Prescribing Information, including Boxed
WARNINGS and Medication Guide, for
BLINCYTO® at www.BLINCYTO.com.
About KYPROLIS® (carfilzomib)
Proteasomes
play an important role in cell function and growth by breaking down
proteins that are damaged or no longer needed. KYPROLIS has been
shown to block proteasomes, leading to an excessive build-up of
proteins within cells. In some cells, KYPROLIS can cause cell
death, especially in myeloma cells because they are more likely to
contain a higher amount of abnormal proteins.
KYPROLIS is approved in the U.S. for the following:
- In combination with dexamethasone or with lenalidomide plus
dexamethasone for the treatment of patients with relapsed or
refractory multiple myeloma who have received one to three lines of
therapy.
- As a single agent for the treatment of patients with relapsed
or refractory multiple myeloma who have received one or more lines
of therapy.
KYPROLIS is also approved in Argentina, Brazil, Canada, Colombia, the EU, Israel, Japan, Korea, Kuwait, Lebanon, Mexico, Thailand, Turkey, Russia, Switzerland, Qatar and the UAE. Additional regulatory
applications for KYPROLIS are underway and have been submitted to
health authorities worldwide.
For more U.S. information, please visit www.kyprolis.com.
IMPORTANT SAFETY INFORMATION
Cardiac Toxicities
- New onset or worsening of pre-existing cardiac failure (e.g.,
congestive heart failure, pulmonary edema, decreased ejection
fraction), restrictive cardiomyopathy, myocardial ischemia, and
myocardial infarction including fatalities have occurred following
administration of KYPROLIS. Some events occurred in patients with
normal baseline ventricular function. Death due to cardiac arrest
has occurred within one day of KYPROLIS administration.
- Monitor patients for clinical signs or symptoms of cardiac
failure or cardiac ischemia. Evaluate promptly if cardiac toxicity
is suspected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse
events until recovery, and consider whether to restart KYPROLIS at
1 dose level reduction based on a benefit/risk assessment.
- While adequate hydration is required prior to each dose in
Cycle 1, monitor all patients for evidence of volume overload,
especially patients at risk for cardiac failure. Adjust total fluid
intake as clinically appropriate in patients with baseline cardiac
failure or who are at risk for cardiac failure.
- Patients ≥ 75 years, the risk of cardiac failure is increased.
Patients with New York Heart Association Class III and IV heart
failure, recent myocardial infarction, conduction abnormalities,
angina, or arrhythmias may be at greater risk for cardiac
complications and should have a comprehensive medical assessment
(including blood pressure and fluid management) prior to starting
treatment with KYPROLIS and remain under close follow-up.
Acute Renal Failure
- Cases of acute renal failure and renal insufficiency adverse
events (including renal failure) have occurred in patients
receiving KYPROLIS. Acute renal failure was reported more
frequently in patients with advanced relapsed and refractory
multiple myeloma who received KYPROLIS monotherapy. Monitor renal
function with regular measurement of the serum creatinine and/or
estimated creatinine clearance. Reduce or withhold dose as
appropriate.
Tumor Lysis Syndrome
- Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes,
have occurred in patients receiving KYPROLIS. Patients with
multiple myeloma and a high tumor burden should be considered at
greater risk for TLS. Adequate hydration is required prior to each
dose in Cycle 1, and in subsequent cycles as needed. Consider uric
acid lowering drugs in patients at risk for TLS. Monitor for
evidence of TLS during treatment and manage promptly. Withhold
KYPROLIS until TLS is resolved.
Pulmonary Toxicity
- Acute Respiratory Distress Syndrome (ARDS), acute respiratory
failure, and acute diffuse infiltrative pulmonary disease such as
pneumonitis and interstitial lung disease have occurred in patients
receiving KYPROLIS. Some events have been fatal. In the event of
drug-induced pulmonary toxicity, discontinue KYPROLIS.
Pulmonary Hypertension
- Pulmonary arterial hypertension (PAH) was reported in patients
treated with KYPROLIS. Evaluate with cardiac imaging and/or other
tests as indicated. Withhold KYPROLIS for PAH until resolved or
returned to baseline and consider whether to restart KYPROLIS based
on a benefit/risk assessment.
Dyspnea
- Dyspnea was reported in patients treated with KYPROLIS.
Evaluate dyspnea to exclude cardiopulmonary conditions including
cardiac failure and pulmonary syndromes. Stop KYPROLIS for Grade 3
or 4 dyspnea until resolved or returned to baseline. Consider
whether to restart KYPROLIS based on a benefit/risk
assessment.
Hypertension
- Hypertension, including hypertensive crisis and hypertensive
emergency, has been observed with KYPROLIS. Some of these events
have been fatal. Monitor blood pressure regularly in all patients.
If hypertension cannot be adequately controlled, withhold KYPROLIS
and evaluate. Consider whether to restart KYPROLIS based on a
benefit/risk assessment.
Venous Thrombosis
- Venous thromboembolic events (including deep venous thrombosis
and pulmonary embolism) have been observed with KYPROLIS.
Thromboprophylaxis is recommended for patients being treated with
the combination of KYPROLIS with dexamethasone or with lenalidomide
plus dexamethasone. The thromboprophylaxis regimen should be based
on an assessment of the patient's underlying risks.
- Patients using oral contraceptives or a hormonal method of
contraception associated with a risk of thrombosis should consider
an alternative method of effective contraception during treatment
with KYPROLIS in combination with dexamethasone or lenalidomide
plus dexamethasone.
Infusion Reactions
- Infusion reactions, including life-threatening reactions, have
occurred in patients receiving KYPROLIS.
- Symptoms include fever, chills, arthralgia, myalgia, facial
flushing, facial edema, vomiting, weakness, shortness of breath,
hypotension, syncope, chest tightness, or angina. These reactions
can occur immediately following or up to 24 hours after
administration of KYPROLIS. Premedicate with dexamethasone to
reduce the incidence and severity of infusion reactions. Inform
patients of the risk and of symptoms of an infusion reaction and to
contact a physician immediately if they occur.
Hemorrhage
- Fatal or serious cases of hemorrhage have been reported in
patients receiving KYPROLIS. Hemorrhagic events have included
gastrointestinal, pulmonary, and intracranial hemorrhage and
epistaxis. Promptly evaluate signs and symptoms of blood loss.
Reduce or withhold dose as appropriate.
Thrombocytopenia
- KYPROLIS causes thrombocytopenia with recovery to baseline
platelet count usually by the start of the next cycle.
Thrombocytopenia was reported in patients receiving KYPROLIS.
Monitor platelet counts frequently during treatment with KYPROLIS.
Reduce or withhold dose as appropriate.
Hepatic Toxicity and Hepatic Failure
- Cases of hepatic failure, including fatal cases, have been
reported during treatment with KYPROLIS. KYPROLIS can cause
increased serum transaminases. Monitor liver enzymes regularly
regardless of baseline values. Reduce or withhold dose as
appropriate.
Thrombotic Microangiopathy
- Cases of thrombotic microangiopathy, including thrombotic
thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS),
including fatal outcome have occurred in patients receiving
KYPROLIS. Monitor for signs and symptoms of TTP/HUS. Discontinue
KYPROLIS if diagnosis is suspected. If the diagnosis of TTP/HUS is
excluded, KYPROLIS may be restarted. The safety of reinitiating
KYPROLIS therapy in patients previously experiencing TTP/HUS is not
known.
Posterior Reversible Encephalopathy Syndrome (PRES)
- Cases of PRES have occurred in patients receiving KYPROLIS.
PRES was formerly known as Reversible Posterior Leukoencephalopathy
Syndrome. Consider a neuro-radiological imaging (MRI) for onset of
visual or neurological symptoms. Discontinue KYPROLIS if PRES is
suspected and evaluate. The safety of reinitiating KYPROLIS therapy
in patients previously experiencing PRES is not known.
Embryo-fetal Toxicity
- KYPROLIS can cause fetal harm when administered to a pregnant
woman based on its mechanism of action and findings in
animals.
- Females of reproductive potential should be advised to avoid
becoming pregnant while being treated with KYPROLIS. Males of
reproductive potential should be advised to avoid fathering a child
while being treated with KYPROLIS. If this drug is used during
pregnancy, or if pregnancy occurs while taking this drug, the
patient should be apprised of the potential hazard to the
fetus.
ADVERSE REACTIONS
- The most common adverse reactions occurring in at least 20% of
patients treated with KYPROLIS in the combination therapy trials:
anemia, neutropenia, diarrhea, dyspnea, fatigue, thrombocytopenia,
pyrexia, insomnia, muscle spasm, cough, upper respiratory tract
infection, hypokalemia.
- The most common adverse reactions occurring in at least 20% of
patients treated with KYPROLIS in monotherapy trials: anemia,
fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea,
headache, cough, edema peripheral.
Please see full prescribing information
at www.kyprolis.com.
About Nplate® (romiplostim)
Nplate is
approved in over 50 countries worldwide, including the
U.S., EU, Canada, Australia, Russia,
Mexico, Switzerland, Lichtenstein, Japan, Argentina, Israel, South Korea, Hong Kong
and Chile. Nplate also has received orphan designation for
chronic ITP in the U.S. (2003), the EU (2005) and other parts of
the world.
Nplate is the first FDA-approved treatment specifically for
adult chronic ITP.
In the U.S., Nplate is indicated for the treatment of
thrombocytopenia in patients with chronic ITP who have had an
insufficient response to corticosteroids, immunoglobulins or
splenectomy. Nplate is not indicated for the treatment of
thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause
of thrombocytopenia other than chronic ITP. Nplate should be
used only in patients with ITP whose degree of thrombocytopenia and
clinical condition increase the risk for bleeding. Nplate should
not be used in an attempt to normalize platelet counts.
In the EU, Nplate is indicated for adult chronic-immune
(idiopathic)-thrombocytopenic-purpura (ITP) patients who are
refractory to other treatments (e.g. corticosteroids,
immunoglobulins).
Nplate was named as a recipient of the U.S. Prix Galien 2009
"Best Biotechnology Product" award and also received the 2009 Scrip
Awards for "Best New Drug." Nplate has also been honored with
numerous awards throughout the EU, including a 2010 Prix Galien
in France in the category of "Drugs for Rare Diseases,"
and the 2011 Prix Galien in Germany in the category of
"Specialist Care." In September 2010, Nplate was awarded the
2010 International Prix Galien Award, an award granted every two
years which recognizes the "best of the best" selected from
previous national Prix Galien award recipients.
For more information about Nplate, please
visit www.Nplate.com.
Important U.S. Nplate® Safety
Information
Risk of Progression of Myelodysplastic Syndromes to Acute
Myelogenous Leukemia
- In Nplate® clinical trials of patients with
myelodysplastic syndromes (MDS) and severe thrombocytopenia,
progression from MDS to acute myelogenous leukemia (AML) has been
observed.
- Nplate® is not indicated for the treatment of
thrombocytopenia due to MDS or any cause of thrombocytopenia other
than chronic ITP.
Thrombotic/Thromboembolic Complications
- Thrombotic/thromboembolic complications may result from
increases in platelet counts with Nplate® use.
Portal vein thrombosis has been reported in patients with chronic
liver disease receiving Nplate®.
- To minimize the risk for thrombotic/thromboembolic
complications, do not use Nplate® in an attempt to
normalize platelet counts. Follow the dose adjustment guidelines to
achieve and maintain a platelet count of ≥ 50 x
109/L.
Loss of Response to Nplate®
- Hyporesponsiveness or failure to maintain a platelet response
with Nplate® should prompt a search for causative
factors, including neutralizing antibodies to
Nplate®.
- To detect antibody formation, submit blood samples
to Amgen (1-800-772-6436). Amgen will assay
these samples for antibodies to Nplate® and
thrombopoietin (TPO).
- Discontinue Nplate® if the platelet count does
not increase to a level sufficient to avoid clinically important
bleeding after 4 weeks at the highest weekly dose of 10
mcg/kg.
Laboratory Monitoring
- Obtain CBCs, including platelet counts, weekly during the dose
adjustment phase of
- Nplate® therapy and then monthly following
establishment of a stable Nplate® dose.
- Obtain CBCs, including platelet counts, weekly for at least two
weeks following discontinuation of Nplate®.
Adverse Reactions
- In the placebo-controlled trials, headache was the most
commonly reported adverse drug reaction, occurring in 35% of
patients receiving Nplate® and 32% of
patients receiving placebo. Headaches were usually of mild or
moderate severity.
- Most common adverse reactions (≥ 5% higher patient incidence in
Nplate® versus placebo) were Arthralgia
(26%, 20%), Dizziness (17%, 0%), Insomnia (16%, 7%), Myalgia (14%,
2%), Pain in Extremity (13%, 5%) , Abdominal Pain (11%, 0%),
Shoulder Pain (8%, 0%), Dyspepsia (7%, 0%), and Paresthesia (6%,
0%).
- Nplate® administration may increase the
risk for development or progression of reticulin fiber formation
within the bone marrow. This formation may improve upon
discontinuation of Nplate®. In a clinical trial,
one patient with ITP and hemolytic anemia developed marrow fibrosis
with collagen during Nplate® therapy.
Please see full U.S. Prescribing Information and
Medication Guide at www.Nplate.com
About Amgen's Commitment to Oncology
Amgen
Oncology is committed to helping patients take on some of the
toughest cancers, such as those that have been resistant to drugs,
those that progress rapidly through the body and those where
limited treatment options exist. Amgen's supportive care
treatments help patients combat certain side effects of strong
chemotherapy, and our targeted medicines and immunotherapies focus
on more than a dozen different malignancies, ranging from blood
cancers to solid tumors. With decades of experience providing
therapies for cancer patients, Amgen continues to grow
its portfolio of innovative and biosimilar oncology medicines.
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 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 after they are
on the market.
Our results may be affected by our ability to successfully
market both new and existing products domestically and
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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
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and domestic and international trends toward managed care and
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Further, while we routinely obtain patents for our products and
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intellectual property litigation. We perform a substantial amount
of our commercial manufacturing activities at a few key facilities
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activities, and limits on supply may constrain sales of certain of
our current products and product candidate development. In
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of new products. Further, some raw materials, medical devices and
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suppliers. The discovery of significant problems with a product
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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
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ability to pay a dividend or repurchase our common stock.
The scientific information discussed in this news release
relating to new indications for our products is preliminary and
investigative and is not part of the labeling approved by
the U.S. Food and Drug Administration 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)
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