THOUSAND OAKS, Calif.,
Jan. 9, 2017 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced it has entered into a six-year
Sourcing and Supply Agreement with DaVita Inc. This is a
continuation of Amgen's long-term relationship with DaVita that is
focused on serving dialysis patients.
Under the terms of the new agreement, Amgen will supply DaVita
with EPOGEN® (epoetin alfa) and Aranesp®
(darbepoetin alfa) in amounts necessary to meet a specified annual
percentage of DaVita's and its affiliates' requirements for
erythropoiesis-stimulating agents used in providing dialysis
services in the United States and
Puerto Rico. The percentage varies
during the term of the new agreement from Jan. 6, 2017, through Dec.
31, 2022, but in each year is at least 90 percent. The new
agreement will replace the Sourcing and Supply Agreement dated
Nov. 15, 2011, between Amgen and
DaVita that would have expired on Dec. 31, 2018.
About EPOGEN® (epoetin alfa) and
Aranesp® (darbepoetin alfa) in the
U.S.
EPOGEN® (epoetin alfa) is indicated for the treatment
of anemia due to chronic kidney disease (CKD) in patients on
dialysis to decrease the need for red blood cell (RBC)
transfusion.
Aranesp® (darbepoetin alfa) is indicated for the
treatment of anemia due to chronic kidney disease (CKD), including
patients on dialysis and patients not on dialysis.
Limitations of Use:
- Aranesp and EPOGEN have not been shown to improve quality of
life, fatigue, or patient well-being.
- Aranesp and EPOGEN are not indicated for use as a substitute for
RBC transfusions in patients who require immediate correction of
anemia.
EPOGEN and Aranesp Important Safety Information in the
U.S.
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL
INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR
ACCESS AND TUMOR PROGRESSION OR RECURRENCE
Chronic Kidney Disease:
- In controlled trials, patients experienced greater risks for
death, serious adverse cardiovascular reactions, and stroke when
administered erythropoiesis-stimulating agents (ESAs) to target a
hemoglobin level of greater than 11 g/dL.
- No trial has identified a hemoglobin target level, ESA dose,
or dosing strategy that does not increase these risks.
- Use the lowest Aranesp® or
EPOGEN® dose sufficient to reduce the need
for red blood cell (RBC) transfusions.
Cancer:
- ESAs shortened overall survival and/or increased the risk of
tumor progression or recurrence in clinical studies of patients
with breast, non-small cell lung, head and neck, lymphoid, and
cervical cancers.
- Because of these risks, prescribers and hospitals must
enroll in and comply with the ESA APPRISE Oncology Program to
prescribe and/or dispense Aranesp® or
EPOGEN® to patients with cancer. To enroll
in the ESA APPRISE Oncology Program, visit www.esa-apprise.com or
call 1-866-284-8089 for further assistance.
- To decrease these risks, as well as the risk of serious
cardiovascular and thromboembolic reactions, use the lowest dose
needed to avoid RBC transfusions.
- Use ESAs only for anemia from myelosuppressive
chemotherapy.
- ESAs are not indicated for patients receiving
myelosuppressive chemotherapy when the anticipated outcome is
cure.
- Discontinue following the completion of a chemotherapy
course.
Perisurgery (EPOGEN®):
- Due to increased risk of Deep Venous Thrombosis (DVT), DVT
prophylaxis is recommended.
- Aranesp® (darbepoetin alfa) and
EPOGEN® (epoetin alfa) are contraindicated in
patients with:
- Uncontrolled hypertension
- Pure red cell aplasia (PRCA) that begins after treatment with
Aranesp®, EPOGEN®, or
other erythropoietin protein drugs
- Serious allergic reactions to
Aranesp® or EPOGEN®
- EPOGEN® from multidose vials contains benzyl
alcohol and is contraindicated in neonates, infants, pregnant
women, and nursing mothers.
- Use caution in patients with coexistent cardiovascular disease
and stroke.
- Patients with CKD and an insufficient hemoglobin response to
ESA therapy may be at even greater risk for cardiovascular
reactions and mortality than other patients. A rate of hemoglobin
rise of > 1 g/dL over 2 weeks may contribute to these
risks.
- In controlled clinical trials, ESAs increased the risk of death
in patients undergoing coronary artery bypass graft surgery (CABG)
and the risk of deep venous thrombosis (DVT) in patients undergoing
orthopedic procedures.
- Control hypertension prior to initiating and during treatment
with Aranesp® or EPOGEN®.
- Aranesp® and EPOGEN®
increase the risk of seizures in patients with CKD. Monitor
patients closely for new-onset seizures, premonitory symptoms, or
change in seizure frequency.
- For lack or loss of hemoglobin response to
Aranesp® or EPOGEN®,
initiate a search for causative factors. If typical causes of lack
or loss of hemoglobin response are excluded, evaluate for
PRCA.
- Cases of PRCA and of severe anemia, with or without other
cytopenias that arise following the development of neutralizing
antibodies to erythropoietin have been reported in patients treated
with Aranesp® or EPOGEN®.
- This has been reported predominantly in patients with CKD
receiving ESAs by subcutaneous administration.
- PRCA has also been reported in patients receiving ESAs for
anemia related to hepatitis C treatment (an indication for which
Aranesp® and EPOGEN® are
not approved).
- If severe anemia and low reticulocyte count develop during
treatment with Aranesp® or
EPOGEN®, withhold
Aranesp® or EPOGEN® and
evaluate patients for neutralizing antibodies to
erythropoietin.
- Permanently discontinue Aranesp® or
EPOGEN® in patients who develop PRCA following
treatment with Aranesp®,
EPOGEN®, or other erythropoietin protein drugs.
Do not switch patients to other ESAs.
- Serious allergic reactions, including anaphylactic reactions,
angioedema, bronchospasm, skin rash, and urticaria may occur with
Aranesp® or EPOGEN®.
Immediately and permanently discontinue
Aranesp® or EPOGEN® if a
serious allergic reaction occurs.
- Adverse reactions (≥ 10%) in
Aranesp® clinical studies in patients with
CKD were hypertension, dyspnea, peripheral edema, cough, and
procedural hypotension.
- Adverse reactions (≥ 5%) in EPOGEN® clinical
studies in patients with CKD were hypertension, arthralgia, muscle
spasm, pyrexia, dizziness, medical device malfunction, vascular
occlusion, and upper respiratory tract infection.
Please see EPOGEN® full Prescribing
Information, including Boxed WARNINGS, and Medication
Guide.
Please see Aranesp® full Prescribing
Information, including Boxed WARNINGS, and Medication
Guide.
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.
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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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SOURCE Amgen