THOUSAND OAKS, Calif., Jan. 9, 2017
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.
- 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.
- 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.
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.
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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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