THOUSAND OAKS, Calif. and
MONROVIA, Calif., Sept. 16, 2015 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and Xencor, Inc. (Xencor) (NASDAQ:XNCR) announced
today that the two companies have entered into a research and
license agreement to develop and commercialize novel therapeutics
in the areas of cancer immunotherapy and inflammation. The research
collaboration brings together Amgen's capabilities in target
discovery and protein therapeutics with Xencor's XmAb®
bispecific technology platform.
The collaboration includes molecular engineering by Xencor and
the preclinical development of bispecific molecules for five
programs proposed by Amgen, leveraging XmAb bispecific Fc domains
to make half-life extended T cell engagers and dual targeting
bispecific antibodies. The agreement also includes a preclinical
bispecific T cell engager program directed at CD38 and CD3 for
multiple myeloma.
Amgen will be fully responsible for preclinical and clinical
development and commercialization worldwide. Under the terms of the
agreement, Xencor will receive a $45
million upfront payment and up to $1.7 billion in clinical, regulatory and sales
milestone payments in total for the six programs. Xencor is
eligible to receive mid to high single-digit royalties for
candidates directed against Amgen's targets, and high single to low
double-digit royalties for Xencor's CD38 bispecific T cell
engager.
"We are pleased to be joining forces with Xencor to expand our
immuno-oncology and inflammation position by leveraging Amgen's
antibodies and Xencor's bispecific antibody platform," said
Sean E. Harper, M.D., executive vice
president of Research and Development at Amgen. "We are especially
excited about the T cell engaging bispecific antibody directed
against CD38, which complements Amgen's BiTE® platform,
while growing our hematology and oncology portfolio that includes
two bispecific T cell engager antibodies, BLINCYTO®
(blinatumomab) and AMG 330, as well as Kyprolis®
(carfilzomib) for relapsed multiple myeloma."
Bispecific technologies seek to engineer monoclonal antibodies
to bind two unique drug targets, as opposed to traditional
antibodies designed to bind to a single antigen target. This
approach represents a powerful opportunity in immuno-oncology to
simultaneously engage immune cells and tumor cells to localize
anti-tumor immune activity where it is needed most.
"Amgen, which has pioneered the use of bispecific antibodies,
has chosen to access our XmAb bispecific technology for its
robustness, long half-life, and the plug and play
ease-of-development of our platform," said Bassil Dahiyat, Ph.D., president and chief
executive officer of Xencor. "This opportunity expands the reach of
our technology with a partner that has proven experience in
bispecifics and immuno-oncology. Xencor will continue to focus on
its internal programs including its immuno-oncology XmAb
bispecifics, XmAb14045 in acute myeloid leukemia and XmAb13676 in
B-cell malignancies, which are expected to enter clinical
development in 2016."
About Xencor's XmAb® Bispecific
Technology
As opposed to traditional monoclonal antibodies
that target and bind to a single antigen, bispecific antibodies are
designed to elicit multiple biological effects that require
simultaneous binding to two different antigen targets. Xencor's
XmAb bispecific Fc domain technology is designed to maintain
full-length antibody properties in a bispecific antibody,
potentially enabling favorable in vivo half-life and simplified
manufacturing.
Efforts at bispecific antibody design are typically frustrated
by poor molecular stability, difficulties in production and short
in vivo half-life. Xencor has engineered a series of Fc domain
variants that spontaneously form stable, heterodimeric bispecific
antibodies and that can be made and purified with standard antibody
production methods. These bispecific Fc domains are used to
generate a broad array of novel drug candidates in a range of
molecule formats.
Xencor's initial bispecific programs are tumor-targeted
antibodies that contain both a tumor antigen binding domain and a
cytotoxic T-cell binding domain (CD3 binding domain). These
bispecific antibodies activate T cells at the site of the tumor for
highly potent killing of malignant cells. The XmAb Fc domain format
allows Xencor to tune the potency of the T-cell killing,
potentially improving the tolerability of tumor immunotherapy.
Xencor plans to begin clinical testing for two internal programs,
XmAb14045 and XmAb13676, in 2016.
About Xencor Inc.
Xencor is a clinical-stage
biopharmaceutical company developing engineered monoclonal
antibodies for the treatment of asthma and allergic diseases,
autoimmune diseases and cancer. Currently, eight candidates that
have been engineered with Xencor's XmAb® technology are
in clinical development internally and with partners. Xencor's
internally-discovered programs include: XmAb5871, which completed a
Phase 1b/2a clinical trial for the treatment of rheumatoid
arthritis and is in preparation for a clinical trial in
IgG4-related disease in 2015; XmAb7195 in Phase 1a development for
the treatment of asthma; and XmAb5574/MOR208 which has been
licensed to Morphosys AG and is in Phase 2 clinical trials for the
treatment of acute lymphoblastic leukemia and non-Hodgkin's
lymphoma. Xencor's XmAb antibody engineering technology enables
small changes to the structure of monoclonal antibodies resulting
in new mechanisms of therapeutic action. Xencor partners include
Merck, Janssen R&D LLC, Alexion, Novo Nordisk and Boehringer
Ingelheim. For more information, please visit
www.xencor.com.
About Amgen's Immuno-Oncology Focused
Partnerships
Amgen's recent immuno-oncology focused
partnerships include:
- A collaboration with Merck on developing talimogene
laherparepvec and KEYTRUDA® (pembrolizumab) in melanoma
and small cell cancer of the head and neck.
- A strategic research collaboration and license agreement to
develop and commercialize the next generation of novel Chimeric
Antigen Receptor (CAR) T cell immunotherapies with Kite
Pharma.
- A research collaborative agreement focusing on Amgen's
bispecific T cell engager (BiTE®) antibody constructs
with MD Anderson's Moon Shots Program.
- A collaboration with Roche on a cancer immunotherapy study with
investigational medicines talimogene laherparepvec and
atezolizumab.
About Kyprolis® (carfilzomib) for
Injection
Kyprolis® (carfilzomib) for Injection
is indicated in combination with lenalidomide and dexamethasone for
the treatment of patients with multiple myeloma who have received
one to three prior lines of therapy.
Kyprolis is also indicated under FDA accelerated approval as a
single agent for the treatment of patients with multiple myeloma
who have received at least two prior therapies including bortezomib
and an immunomodulatory agent and have demonstrated disease
progression on or within 60 days of completion of the last therapy.
Approval is based on response rate. Clinical benefit, such as
improvement in survival or symptoms, has not been verified.
Kyprolis is a product of Onyx Pharmaceuticals, Inc. Onyx
Pharmaceuticals is a subsidiary of Amgen and holds development and
commercialization rights to Kyprolis globally, excluding
Japan. Kyprolis is also approved
for use in Argentina, Israel, Mexico and Thailand. For more information about Kyprolis,
visit www.kyprolis.com
Important Safety Information Regarding Kyprolis®
(carfilzomib) for Injection
WARNINGS AND PRECAUTIONS
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. In clinical studies
with Kyprolis, these events typically occurred early in the course
of Kyprolis therapy (< 5 cycles). Death due to cardiac arrest
has occurred within a day of Kyprolis administration. 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, all patients should also be
monitored 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. In patients ≥ 75 years of age, the risk
of cardiac failure is increased. Patients with New York Heart
Association Class III and IV heart failure, recent myocardial
infarction, and conduction abnormalities uncontrolled by
medications were not eligible for the clinical trials. These
patients may be at greater risk for cardiac complications.
Acute Renal Failure:
Cases of acute renal failure have
occurred in patients receiving Kyprolis. Renal insufficiency
adverse events (renal impairment, acute renal failure, renal
failure) have occurred with an incidence of approximately 8% in a
randomized controlled trial. Acute renal failure was reported more
frequently in patients with advanced relapsed and refractory
multiple myeloma who received Kyprolis monotherapy. This risk was
greater in patients with a baseline reduced estimated creatinine
clearance (calculated using Cockcroft and Gault equation). 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
been reported in patients who received Kyprolis. Patients with
multiple myeloma and a high tumor burden should be considered to be
at greater risk for TLS. Ensure that patients are well hydrated
before administration of Kyprolis 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 including interruption of Kyprolis until TLS is
resolved.
Pulmonary Toxicity:
Acute Respiratory Distress Sndrome (ARDS), acute respiratory
failure, and acute diffuse infiltrative pulmonary disease such as
pneumonitis and interstitial lung disease have occurred in less
than 1% of 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 approximately
1% of patients treated with Kyprolis and was Grade 3 or greater in
less than 1% of patients. Evaluate with cardiac imaging and/or
other tests as indicated. Withhold Kyprolis for pulmonary 11
hypertension until resolved or returned to baseline and consider
whether to restart Kyprolis based on a benefit/risk assessment.
Dyspnea:
Dyspnea was reported in 28% of patients
treated with Kyprolis and was Grade 3 or greater in 4 % of
patients. 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. In the
combination study, the incidence of venous thromboembolic events in
the first 12 cycles was 13% in the Kyprolis combination arm versus
6% in the control arm. With Kyprolis monotherapy, the incidence of
venous thromboembolic events was 2%. Thromboprophylaxis is
recommended and should be based on an assessment of the patient's
underlying risks, treatment regimen, and clinical status.
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.
Administer dexamethasone prior to Kyprolis to reduce the incidence
and severity 12 of infusion reactions. Inform patients of the risk
and of symptoms and to contact a physician immediately if symptoms
of an infusion reaction occur.
Thrombocytopenia:
Kyprolis causes thrombocytopenia
with platelet nadirs observed between Day 8 and Day 15 of each
28-day cycle with recovery to baseline platelet count usually by
the start of the next cycle. Thrombocytopenia was reported in
approximately 40% of patients in clinical trials with 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
(< 1%) during treatment with Kyprolis. Kyprolis can cause
increased serum transaminases. Monitor liver enzymes regularly.
Reduce or withhold dose as appropriate.
Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic
Syndrome:
Cases of thrombotic thrombocytopenic purpura/hemolytic uremic
syndrome (TTP/HUS) including fatal outcome have been reported in
patients who received Kyprolis. Monitor for signs and symptoms of
TTP/HUS. If the diagnosis is suspected, stop Kyprolis and evaluate.
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 been reported in patients receiving Kyprolis.
Posterior reversible encephalopathy syndrome (PRES), formerly
termed Reversible Posterior Leukoencephalopathy Syndrome (RPLS), is
a neurological disorder which can present with seizure, headache,
lethargy, confusion, blindness, altered consciousness, and other
visual and neurological disturbances, along with hypertension, and
the diagnosis is confirmed by neuro-radiological imaging (MRI).
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. There are
no adequate and well-controlled studies in pregnant women using
Kyprolis. Kyprolis caused embryo-fetal toxicity in pregnant rabbits
at doses that were lower than in patients receiving the recommended
dose. Females of reproductive potential should be advised to avoid
becoming pregnant while being treated with Kyprolis. If this drug
is used during pregnancy, or if the patient becomes pregnant while
taking this drug, the patient should be apprised of the potential
hazard to the fetus.
ADVERSE REACTIONS
The most common adverse events
occurring in at least 20% of patients treated with Kyprolis in
monotherapy trials: anemia, fatigue, thrombocytopenia, nausea,
pyrexia, decreased platelets, dyspnea, diarrhea, decreased
lymphocyte, headache, decreased hemoglobin, cough, edema
peripheral.
The most common adverse events occurring in at least 20% of
patients treated with Kyprolis in the combination therapy trial:
decreased lymphocytes, decreased absolute neutrophil count,
decreased phosphorus, anemia, neutropenia, decreased total white
blood cell count, decreased platelets, diarrhea, fatigue,
thrombocytopenia, pyrexia, muscle spasm, cough, upper respiratory
tract infection, decreased hemoglobin, hypokalemia.
USE IN SPECIFIC POPULATIONS
Patients on dialysis:
Administer Kyprolis after the dialysis procedure.
POST-MARKETING EXPERIENCE
The following adverse
reactions were reported in the post-marketing experience:
dehydration, thrombotic thrombocytopenic purpura/hemolytic uremic
syndrome (TTP/HUS), tumor lysis syndrome including fatal outcomes,
and posterior reversible encephalopathy syndrome (PRES). Because
these reactions are reported voluntarily from a population of
uncertain size, it is not always possible to reliably estimate
their frequency or establish a causal relationship to drug
exposure.
Full prescribing information is available at
www.kyprolis.com.
About BLINCYTO®
(blinatumomab)
BLINCYTO® (blinatumomab) is
the first bispecific CD19-directed CD3 T cell engager
(BiTE®) antibody construct product, and the first
single-agent immunotherapy to be approved by the U.S. Food and Drug
Administration (FDA) for the treatment of patients with
Philadelphia chromosome-negative
(Ph-) relapsed or refractory B-cell precursor acute lymphoblastic
leukemia (ALL), a rare and rapidly progressing cancer of the
blood and bone marrow.1,2 Prior to approval,
BLINCYTO was granted breakthrough therapy and priority review
designations by the FDA. BLINCYTO has a BOXED WARNING in its
product label regarding Cytokine Release Syndrome (CRS) and
Neurological Toxicities. (Please see Important Safety Information
below).
About BiTE® Technology
Bispecific T
cell engager (BiTE®) antibody constructs are a type of
immunotherapy being investigated for fighting cancer by helping the
body's immune system to detect and target malignant cells. The
modified antibodies are designed to engage two different targets
simultaneously, thereby juxtaposing T cells (a type of white blood
cell capable of killing other cells perceived as threats) to cancer
cells. BiTE® antibody constructs help place the T cells
within reach of the targeted cell, with the intent of allowing T
cells to inject toxins and trigger the cancer cell to die
(apoptosis). BiTE® antibody constructs are currently
being investigated for their potential to treat a wide variety of
cancers. For more information, visit www.biteantibodies.com.
Important U.S. Product
Information
BLINCYTO® is indicated for the
treatment of Philadelphia
chromosome-negative relapsed or refractory B-cell precursor acute
lymphoblastic leukemia (ALL).
This indication is approved under accelerated approval. Continued
approval for this indication may be contingent upon verification of
clinical benefit in subsequent trials.
IMPORTANT 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): Life-threatening or fatal CRS
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 50% of patients
receiving BLINCYTO® in clinical trials experienced
neurological toxicities. Severe, life-threatening, or fatal
neurological toxicities occurred in approximately 15% of patients,
including encephalopathy, convulsions, speech disorders,
disturbances in consciousness, confusion and disorientation, and
coordination and balance disorders. The median time to onset of any
neurological toxicity was 7 days. 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): Life-threatening or fatal TLS 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
are associated with BLINCYTO® treatment. The majority of
these events were observed in the setting of CRS. The median time
to onset was 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.
- 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 anti-leukemic chemotherapy.
- Preparation and administration errors have occurred. Follow
instructions for preparation (including admixing) and
administration in the PI strictly to minimize medication errors
(including underdose and overdose).
Adverse Events
- The most commonly reported adverse reactions (≥ 20%) in
clinical trials were pyrexia (62%), headache (36%), peripheral
edema (26%), febrile neutropenia (26%), nausea (25%), hypokalemia
(23%), rash (21%), tremor (20%) and constipation (20%).
- Serious adverse reactions were reported in 65% of patients. The
most common serious adverse reactions (≥ 2%) included febrile
neutropenia, pyrexia, pneumonia, sepsis, neutropenia,
device-related infection, tremor, encephalopathy, infection,
overdose, confusion, Staphylococcal bacteremia, and
headache.
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 and medication guide for
BLINCYTO® at www.BLINCYTO.com.
About AMG 330
AMG 330 is a novel CD33/CD3
BiTE® antibody developed to recruit T cells to recognize
and kill CD33 expressing acute myeloid leukemia (AML) target
cells.
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 biologics manufacturing 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.
Amgen Forward-Looking Statements
This news release
contains forward-looking statements that are based on the current
expectations and beliefs of Amgen Inc. and its
subsidiaries (Amgen) and are subject to a number of risks,
uncertainties and assumptions that could cause actual results to
differ materially from those described. 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 (SEC) reports filed by Amgen Inc.,
including Amgen Inc.'s most recent annual report on Form
10-K and any subsequent periodic reports on Form 10-Q and Form 8-K.
Please refer to Amgen Inc.'s most recent Forms 10-K, 10-Q
and 8-K for additional information on the uncertainties and risk
factors related to Amgen's business. Unless otherwise
noted, Amgen is providing this information as
of Sept. 16, 2015, and expressly disclaims any duty to update
information contained in this news release.
No forward-looking statement can be guaranteed and actual
results may differ materially from those Amgen projects.
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 Amgen and its partners
to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied
and Amgen expects similar variability in the
future. Amgen develops 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 Amgen may have believed at the
time of entering into such relationship. Also, Amgen or
others could identify safety, side effects or manufacturing
problems with Amgen's products after they are on the
market. Amgen's business may be impacted by government
investigations, litigation and product liability claims.
If Amgen fails to meet the compliance obligations in the
corporate integrity agreement between Amgen and the U.S.
government, Amgen could become subject to significant
sanctions. Amgen depends on third parties for a
significant portion of its manufacturing capacity for the supply of
certain of its current and future products and limits on supply may
constrain sales of certain of its current products and product
candidate development.
In addition, sales of Amgen's products are affected by
the 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 as well as U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government and others'
regulations and reimbursement policies may affect the development,
usage and pricing of Amgen's products. In
addition, Amgen competes with other companies with
respect to some of its marketed products as well as for the
discovery and development of new products. Amgen believes that
some of its newer products, product candidates or new indications
for existing products, may face competition when and as they are
approved and marketed. Amgen's products may compete
against products that have lower prices, established reimbursement,
superior performance, are easier to administer, or that are
otherwise competitive with its products. In addition,
while Amgen and its partners routinely obtain patents for
their products and technology, the protection
of Amgen's products offered by patents and patent
applications may be challenged, invalidated or circumvented by its
competitors and there can be no guarantee of Amgen's or
its partners' ability to obtain or maintain patent protection
for Amgen's products or product
candidates. Amgen cannot guarantee that it will be able
to produce commercially successful products or maintain the
commercial success of its existing
products. Amgen's stock price may be affected by actual
or perceived market opportunity, competitive position and success
or failure of its products or product candidates. Further, the
discovery of significant problems with a product similar to one
of Amgen's products that implicate an entire class of
products could have a material adverse effect on sales of the
affected products and on Amgen's business and results of
operations. Amgen's efforts to integrate the operations
of companies it has acquired may not be
successful. Amgen may experience difficulties, delays or
unexpected costs and not achieve anticipated cost savings from its
ongoing restructuring plan. Amgen's business performance
could affect or limit the ability of Amgen's Board of
Directors to declare a dividend or their ability to pay a dividend
or repurchase Amgen common stock.
The scientific information discussed in this news release
related to Amgen's product candidates is preliminary and
investigative. Such product candidates are not approved by
the U.S. Food and Drug Administration (FDA), and no conclusions can
or should be drawn regarding the safety or effectiveness of the
product candidates.
Xencor Forward-Looking Statements
Statements contained
in this press release regarding matters that are not historical
facts are forward-looking statements within the meaning of
applicable securities laws, including the quotation from Xencor's
officers and any expectations relating to its business, research
and development programs, including the XmAb bispecific antibody
technology, partnering efforts or its capital requirements. Such
statements involve known and unknown risks, uncertainties and other
factors that may cause actual results, performance or achievements
and the timing of events to be materially different from
those implied by such statements, and therefore these statements
should not be read as guarantees of future performance or results.
Such risks include, without limitation, the risks associated with
the process of discovering, developing, manufacturing and
commercializing drugs that are safe and effective for use as human
therapeutics and other risks described in Xencor's public
securities filings. All forward-looking statements are based on
Xencor's current information and belief as well as assumptions made
by Xencor. Readers are cautioned not to place undue reliance on
such statements and Xencor disclaims any intention or obligation to
update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(investors)
CONTACT: Xencor, Monrovia
John Kuch, 626-737-8013
(investors)
Jason I. Spark, 619-849-6005 Canale
Communications for Xencor (media)
References
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1 Mayo
Clinic. "Acute lymphocytic leukemia." Available at:
http://www.mayoclinic.org/diseases-conditions/acute-lymphocytic-leukemia/basics/definition/con-20042915
Accessed on July 15, 2015.
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2
BLINCYTO® US Prescribing Information.
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visit:http://www.prnewswire.com/news-releases/amgen-and-xencor-announce-strategic-collaboration-in-cancer-immunotherapy-and-inflammation-300143894.html
SOURCE Amgen