Amgen Announces Top-Line Results Of Phase 3 Aranesp® (darbepoetin alfa) RED-HF® Trial

   Amgen Announces Top-Line Results Of Phase 3 Aranesp® (darbepoetin alfa)
                                RED-HF® Trial

PR Newswire

THOUSAND OAKS, Calif., Jan. 16, 2013

THOUSAND OAKS, Calif., Jan. 16, 2013 /PRNewswire/ --Amgen (NASDAQ:AMGN) today
announced top-line results of the Phase 3 Aranesp^® (darbepoetin alfa)
RED-HF^® (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial.
The trial was initiated in 2006, and a total of 2,278 patients with
symptomatic systolic heart failure and anemia (hemoglobin levels ranging from
9.0-12.0 g/dL) were randomized to receive either treatment with Aranesp to
achieve a target hemoglobin of at least 13.0 g/dL (not to exceed 14.5 g/dL),
or placebo. The study did not meet its primary endpoint of reducing the
composite endpoint of time to death from any cause or first hospital admission
for worsening heart failure (Hazard Ratio 1.01, 95 percent CI 0.90, 1.13).

"The RED-HF Trial was designed and powered to evaluate whether the treatment
of anemia could improve morbidity and mortality in systolic heart failure
patients," said Michael Severino, M.D., senior vice president of Global
Development and corporate chief medical officer at Amgen. "While the study did
not meet its key endpoints, we thank the patients and investigators who
participated in RED-HF and helped answer this important question."

There were no new safety findings identified in the study. The most
frequently reported adverse events in the study were cardiac failure, dyspnea,
diarrhea, congestive heart failure and dizziness.

These summary results will be followed by full efficacy and safety analyses,
which will be shared and discussed with global regulatory agencies and
submitted for presentation at an upcoming medical meeting.

Aranesp is indicated for the treatment of anemia due to chronic kidney disease
in patients on dialysis and not on dialysis, and for the treatment of anemia
in patients with non-myeloid malignancies where anemia is due to the effect of
concomitant myelosuppressive chemotherapy, and upon initiation, there is a
minimum of two additional months of planned chemotherapy. Aranesp has not been
shown to improve quality of life, fatigue or patient well-being. 

RED-HF Trial Design

The RED-HF Trial is a large, event-driven, global, randomized, double-blind,
placebo-controlled, Phase 3 study designed and powered to evaluate the effect
of treatment with Aranesp on mortality and heart failure hospitalization. The
primary endpoint of the study was the composite of time to death from any
cause or first hospital admission for worsening heart failure in patients with
symptomatic left ventricular systolic dysfunction and anemia. Secondary
endpoints include time to death from any cause; time to cardiovascular death
or first hospital admission for worsening heart failure, whichever occurs
first; change from baseline to month 6 in Kansas City Cardiomyopathy
Questionnaire (KCCQ) Overall Summary Score; and change from baseline in KCCQ
Symptom Frequency Score.

Patients with New York Heart Association (NYHA) class II, III or IV heart
failure, left ventricular ejection fraction less than or equal to 40 percent,
and hemoglobin greater than or equal to 9.0 g/dL and less than or equal to
12.0 g/dL were randomized 1:1 to receive subcutaneous Aranesp or placebo. The
dose of Aranesp was titrated to gradually achieve and maintain a hemoglobin
concentration of at least 13.0 g/dL, not to exceed 14.5 g/dL. Investigational
product was administered initially every two weeks and extended to every month
when patients were stable in the hemoglobin target range. The RED-HF Trial was
monitored by an independent Data Monitoring Committee, which reviewed the
study data on a quarterly basis throughout the duration of the trial.

About Aranesp

Aranesp was approved by the U.S. Food and Drug Administration (FDA) in 2001
for the treatment of anemia associated with chronic renal failure (CRF) for
patients on dialysis and patients not on dialysis. The European Commission
granted marketing authorization for the same indication in 2001 and
subsequently updated it for CRF patients with symptomatic anemia in 2008.

In 2002, the FDA approved Aranesp for the treatment of anemia caused by
concomitantly administered chemotherapy in patients with non-myeloid
malignancies.

The European Commission authorized the treatment of anemia caused by
concomitantly administered chemotherapy in patients with non-haematological
malignancies in 2002 and extended it to include non-myeloid malignancies in
patients receiving chemotherapy in 2003.

For full prescribing information outside of the U.S., including important
safety information, please refer to local product labeling.

Important U.S. Aranesp Product Safety Information

Aranesp is indicated for the treatment of anemia due to chronic kidney disease
in patients on dialysis and not on dialysis, and for the treatment of anemia
in patients with non-myeloid malignancies where anemia is due to the effect of
concomitant myelosuppressive chemotherapy, and upon initiation, there is a
minimum of two additional months of planned chemotherapy. Aranesp has not been
shown to improve quality of life, fatigue, or patient well-being. It is not
indicated in patients with cancer receiving hormonal agents, biologic
products, or radiotherapy, unless also receiving concomitant myelosuppressive
chemotherapy; in patients with cancer receiving myelosuppressive chemotherapy
when the anticipated outcome is cure or as a substitute for RBC transfusions
in patients who require immediate correction of anemia.

WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE,
VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR
RECURRENCE.

Chronic Kidney Disease:

  oIn 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.
  oNo trial has identified a hemoglobin target level, Aranesp® dose, or
    dosing strategy that does not increase these risks.
  oUse the lowest Aranesp® dose sufficient to reduce the need for red blood
    cell (RBC) transfusions.

Cancer:

  oESAs 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.
  oBecause of these risks, prescribers and hospitals must enroll in and
    comply with the ESA APPRISE Oncology Program to prescribe and/or dispense
    Aranesp® 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.
  oTo decrease these risks, as well as the risk of serious cardiovascular and
    thromboembolic reactions, use the lowest dose needed to avoid RBC
    transfusions.
  oUse ESAs only for anemia from myelosuppressive chemotherapy.
  oESAs are not indicated for patients receiving myelosuppressive
    chemotherapy when the anticipated outcome is cure.
  oDiscontinue following the completion of a chemotherapy course.

For the full U.S. prescribing information, click here.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first
companies to realize the new science's promise by bringing safe, effective
medicines from lab to manufacturing plant to patient. Amgen therapeutics have
changed the practice of medicine, helping millions of people around the world
in the fight against cancer, kidney disease, rheumatoid arthritis, bone
disease and other serious illnesses. With a deep and broad pipeline of
potential new medicines, Amgen remains committed to advancing science to
dramatically improve people's lives. To learn more about our pioneering
science and vital medicines, visit www.amgen.com. Follow us on
www.twitter.com/amgen.

Forward-Looking Statements

This news release contains forward-looking statements that are based on
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CONTACT: Amgen, Thousand Oaks
Ashleigh Koss, 805-313-6151 (media)
Arvind Sood, 805-447-1060 (investors)

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