Nplate(R) Data Documents Long-Term Safety and Efficacy for
Treatment of Serious Chronic Autoimmune Disorder THOUSAND OAKS,
Calif., Nov. 30 /PRNewswire-FirstCall/ -- Amgen Inc. (NASDAQ:AMGN)
today announced that it will present updated long-term safety and
efficacy data for Nplate® (romiplostim) in adult chronic immune
(idiopathic) thrombocytopenic purpura (ITP). Additionally, Amgen
will present the first Nplate study in a pediatric setting as well
as in patients with myelodysplastic syndromes (MDS) at the 2009
American Society of Hematology (ASH) Annual Meeting and Exposition
(Dec. 5 - 8, 2009). "We are excited to present data on the safety
and efficacy of Nplate in the pediatric setting for the first
time," said Roger M. Perlmutter, M.D., Ph.D., executive vice
president of Research and Development at Amgen. "Similar to adults
who have chronic ITP, children living with this disease have
limited treatment options. We will also present data from a large
global study of Nplate as a treatment for thrombocytopenia in
patients with MDS." SELECTED ABSTRACTS OF INTEREST Abstracts are
available and can be viewed on the ASH website at
http://www.hematology.org/. Identified below are selected abstracts
of interest on Amgen research. Updated data will be presented at
the meeting. Nplate Researchers will present five year follow-up
results from the ongoing, open-label extension study on the
long-term safety and efficacy of Nplate in adult patients with
chronic ITP. Chronic ITP is a serious autoimmune disorder
characterized by low platelet counts in the blood
(thrombocytopenia), which can lead to serious bleeding events.
These results support previously presented data which illustrated
Nplate sustained platelet counts with extended treatment.
Additionally, data regarding pediatric treatment of ITP will be
presented, as well as results for Nplate in MDS. -- Abstract No.
681 (Embargoed until Dec. 7, 5:00pm): "Long-term Efficacy and
Safety of Romiplostim for the Treatment of Patients with Chronic
Immune Thrombocytopenia (ITP): 5-year Update from an Open-label
Extension Study" -- Abstract No. 680 (Embargoed until Dec. 7,
4:45pm): "A Randomized, Double-Blind, Placebo-Controlled Phase 1/2
Study to Determine the Safety and Efficacy of Romiplostim in
Children With Chronic Immune (Idiopathic) Thrombocytopenic Purpura
(ITP)" MDS Data -- Abstract No. 1769 (Embargoed until Dec. 5,
5:30pm): "Efficacy and Safety of Romiplostim in Patients with Low
or Intermediate-Risk Myelodysplastic Syndrome (MDS) Receiving
Decitabine" -- Abstract No. 1770 (Embargoed until Dec. 5, 5:30pm):
"Randomized Phase II Study Evaluating the Efficacy and Safety of
Romiplostim Treatment of Patients with Low or Intermediate Risk
Myelodysplastic Syndrome (MDS) Receiving Lenalidomide" -- Abstract
No. 2765 (Embargoed until Dec. 6, 6:00pm): "An Open-Label Extension
Study Evaluating the Long-Term Safety and Efficacy of Romiplostim
in Thrombocytopenic Patients (Pts) with Myelodysplastic Syndromes
(MDS)" Aranesp® (darbepoetin alfa) Researchers will also present
efficacy and safety data from an independent investigator-led study
that is part of the Aranesp Pharmacovigilance program. -- Abstract
No. 1701 (Embargoed until Dec. 5, 5:30pm): "Efficacy and Safety of
Prophylactic Use of Darbepoetin Alfa in Patients with Diffuse Large
B-Cell Lymphoma (DLBCL) Treated with Immunochemotherapy: Results of
the Interim Analysis of the LNH03-6B GELA Study" About Adult ITP In
patients with chronic ITP, platelets - or blood elements needed to
prevent bleeding - are destroyed by the patient's own immune
system. Low platelet counts leave adult ITP patients open to sudden
serious bleeding events. The risk for serious bleeding events
increases when platelet counts drop to less than 30,000 platelets
per microliter; normal counts range from 150,000 to 400,000
platelets per microliter. ITP has historically been considered a
disease of platelet destruction although recent data suggest that
the body's natural platelet production processes in ITP are unable
to compensate for low levels of platelets in the blood. Increasing
the rate of platelet production may address low platelet levels
associated with ITP. Currently available treatments (i.e.,
corticosteroids, immunoglobulins) have limited application due to
poor tolerability or transient effects. Surgical therapy (removal
of the spleen) is also available to adult patients with chronic
ITP, but does not work in all cases. Currently, there are
approximately 90,000 adult chronic ITP patients in Europe and the
United States (U.S.). ITP affects about twice as many adult women
as men. About Nplate Nplate was the first platelet producer
approved in the European Union (EU), Canada, Australia, Russia and
the U.S. Nplate was granted approval for chronic ITP by the
regulatory bodies in Australia, Canada, Europe, Russia and the U.S.
Nplate also has received orphan designation for chronic ITP in the
U.S. (2003), the EU (2005), Switzerland (2005) and Japan (2006).
Nplate is the first treatment specifically developed for chronic
ITP. It is also being investigated for potential use in pediatric
ITP, MDS and chemotherapy-induced thrombocytopenia (CIT). 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 should be
used only in patients with ITP whose degree of thrombocytopenia and
clinical condition increases the risk for bleeding. Nplate should
not be used in an attempt to normalize platelet counts. In the EU,
Nplate is indicated for the treatment of splenectomized adult
chronic ITP patients who are refractory to other treatments (e.g.
corticosteroids, immunoglobulins). Nplate may be considered as a
second-line treatment for adult non-splenectomized ITP patients for
whom surgery is contra-indicated. Nplate was named the recipient of
the U.S. Prix Galien 2009 "Best Biotechnology Product" award and
also received the 2009 Scrip Award for "Best New Drug." Important
U.S. Nplate Safety Information Serious adverse reactions associated
with Nplate in clinical studies were bone marrow reticulin
deposition and worsening thrombocytopenia after Nplate
discontinuation. Additional risks include bone marrow fibrosis,
thrombotic/thromboembolic complications, lack or loss of response
to Nplate, and hematological malignancies and progression of
malignancy in patients with a pre-existing hematological malignancy
or MDS. Nplate is not indicated for the treatment of
thrombocytopenia due to MDS or any cause of thrombocytopenia other
than chronic ITP. In the placebo-controlled studies, headache was
the most commonly reported adverse drug reaction. Important EU
Nplate Safety Information The most common side effects are
headache, fatigue, arthralgia, myalgia, injection site bruising,
injection site pain, peripheral edema, dizziness, muscle spasms,
nausea, contusion, diarrhoea, bone marrow disorder, influenza-like
illness, insomnia and pruritus. Reoccurrence of thrombocytopenia
and bleeding after cessation of treatment and increased bone marrow
reticulin have been associated with romiplostim treatment in the
clinical trials. Thrombotic/thromboembolic complications,
progression of existing hematopoietic malignancies or MDS, and
effects on red and white blood cells are all potential risks
associated with romiplostim treatment. As with all therapeutic
proteins, patients may develop antibodies to the therapeutic
protein. About Aranesp Aranesp was approved by the U.S. Food and
Drug Administration (FDA) in September 2001 for the treatment of
anemia associated with CRF for patients on dialysis and patients
not on dialysis. In July 2002, the FDA approved weekly dosing of
Aranesp for the treatment of anemia caused by concomitantly
administered chemotherapy in patients with nonmyeloid malignancies
and in March 2006, the FDA approved every-three-week dosing in
these patients. Aranesp is a recombinant erythropoietic protein (a
protein that stimulates production of red blood cells, which carry
oxygen). Amgen revolutionized the treatment of anemia with the
development of recombinant erythropoietin, Epoetin alfa. Building
on this heritage, Amgen developed Aranesp, a unique erythropoiesis
stimulating protein, which contains two additional sialic
acid-containing carbohydrate chains compared to the epoetin alfa
molecule and remains in the bloodstream longer than epoetin alfa as
demonstrated by its longer half-life. Aranesp was granted marketing
authorization by the European Commission in 2001 for the treatment
of anemia associated with chronic renal failure (CRF), also known
as chronic kidney disease (CKD), in adults and pediatric subjects
11 years of age or older. In 2002, the European Commission approved
Aranesp for the treatment of anemia in adult cancer patients
receiving chemotherapy with solid tumors. This patient population
was subsequently expanded in 2003 to include treatment of
symptomatic anemia in adult cancer patients with non-myeloid
malignancies receiving chemotherapy. Approval was granted in 2004
for extended dosing intervals of once-every-three-weeks in the
treatment of anemia in adult cancer patients with non-myeloid
malignancies who are receiving chemotherapy and up to
once-per-month Aranesp administration in the treatment of anemia in
CKD patients not on dialysis. In 2006, the Aranesp label was
updated to allow CKD patients on dialysis to switch from rHuEPO one
to three times a week to Aranesp every two weeks. In 2007, the
Aranesp label was updated to allow for treatment of anemia
associated with CRF, in all European pediatric patients on dialysis
or not on dialysis. Important Aranesp Safety Information WARNINGS:
INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC
EVENTS, and TUMOR PROGRESSION Renal failure: Patients experienced
greater risks for death and serious cardiovascular events when
administered erythropoiesis-stimulating agents (ESAs) to target
higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs.
10 g/dL) in two clinical studies. Individualize dosing to achieve
and maintain hemoglobin levels within the range of 10 to 12 g/dL.
Cancer: -- ESAs shortened overall survival and/or time-to-tumor
progression in clinical studies in patients with breast, non-small
cell lung, head and neck, lymphoid, and cervical cancers when dosed
to target a hemoglobin of greater than or equal to 12 g/dL. -- The
risks of shortened survival and tumor progression have not been
excluded when ESAs are dosed to target a hemoglobin of less than 12
g/dL. -- To minimize these risks, as well as the risk of serious
cardio- and thrombovascular events, use the lowest dose needed to
avoid red blood cell transfusions. -- Use only for treatment of
anemia due to concomitant myelosuppressive chemotherapy. -- ESAs
are not indicated for patients receiving myelosuppressive therapy
when the anticipated outcome is cure. (This information is specific
to the U.S. prescribing information) -- Discontinue following the
completion of a chemotherapy course. Aranesp is contraindicated in
patients with uncontrolled hypertension. All patients, including
patients with cancer or chronic kidney failure: -- You may get
serious heart problems such as heart attack, stroke, heart failure,
and may die sooner if you are treated with Aranesp to a hemoglobin
level above 12 g/dL. -- You may get blood clots at any time while
taking Aranesp. If you are receiving Aranesp and you are going to
have surgery, talk to your healthcare provider about whether or not
you need to take a blood thinner to lessen the chance of blood
clots during or following surgery. Clots can form in blood vessels
(veins), especially in your leg (deep venous thrombosis or DVT).
Pieces of a blood clot may travel to the lungs and block the blood
circulation in the lungs (pulmonary embolus). 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 and 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 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 our vital medicines, visit
http://www.amgen.com/. Forward-Looking Statements This news release
contains forward-looking statements that are based on management's
current expectations and beliefs and are subject to a number of
risks, uncertainties and assumptions that could cause actual
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2009 and expressly disclaims any duty to update information
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discussed in this news release. Contact: Amgen, Thousand Oaks Megan
Fox: 310-628-7079 (U.S. media, oncology) Wendy Woods Williams: +41
78 7507 361 (EU media, oncology) Arvind Sood: 805-447-1060
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