Nplate(TM) (Romiplostim) Receives Positive Opinion for Marketing Authorisation in the European Union

Thousand Oaks, California, November 21 (ots/PRNewswire) -

- First and Only Approved Platelet Producer Represents New
Treatment Approach for Serious Chronic Autoimmune Disorder

Amgen (Nasdaq: AMGN) today announced that the European Committee
for Medicinal Products for Human Use (CHMP) has issued a positive
opinion recommending marketing authorisation for Nplate(TM)
(romiplostim) in the European Union (EU). The CHMP recommends Nplate
for adult chronic immune (idiopathic) thrombocytopenia purpura (ITP)
splenectomised patients who are refractory to other treatments (e.g.
corticosteroids, immunoglobulins). Nplate may be considered as second
line treatment for adult non-splenectomised patients where surgery is
contra-indicated.

"Nplate will address an unmet medical need for thousands of
patients in the European Union as it is a unique treatment option
that increases platelet production and avoids immune suppression in
adult chronic ITP patients," said Willard Dere, M.D., senior vice
president and international chief medical officer at Amgen.

The novel peptibody technology upon which romiplostim is based
represents a promising new approach for treating adult patients with
chronic ITP, an autoimmune disorder affecting an estimated 50,000
people in the EU, which can lead to serious bleeding events that can
be potentially life threatening.

Nplate, a thrombopoietin (TPO) mimetic, is a novel engineered
therapeutic fusion protein with attributes of both peptides and
antibodies, but is distinct from each. Nplate works similarly to TPO,
a natural protein in the body. Nplate stimulates the TPO receptor,
which is necessary for growth and maturation of bone marrow cells
that produce platelets.

The CHMP positive opinion is based on data from two separate
placebo-controlled Phase 3 studies, demonstrating that platelet
counts were raised and sustained in 83 percent of patients for both
splenectomised and non-splenectomised groups when treated with
Nplate. Additionally, patients treated with Nplate were able to
reduce or discontinue concomitant ITP and emergency medications which
are often not well tolerated or whose effects are transient (i.e.
corticosteroids, IVIG, Win-Rho Anti-D therapy).

Upon completion of the Phase 3 studies almost 90 percent of
patients elected to subsequently enroll into the romiplostim long
term extension study which demonstrated that, after three years,
Nplate continued to effectively increase and sustain platelet counts.
In this open label long term extension study some patients were
treated for over 156 weeks and in the interim analysis the median
treatment duration in this study is 65 weeks.

About Adult ITP

In patients with ITP, platelets -- or blood cells 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, making it impossible to arrest blood flow. 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 140,000 treated chronic ITP patients
in Europe and the U.S. ITP affects about twice as many adult women as
men.

About Nplate

Nplate was granted approval for ITP by the regulatory bodies in
Australia in July and the United States (U.S.) in August 2008. In
addition to the European Union (EU), Amgen has filed for regulatory
approval of Nplate in Canada and Switzerland and these applications
are currently under review. Nplate has also received orphan
designation for ITP in the U.S. (2003), the EU (2005), Switzerland
(2005) and Japan (2006).

Nplate is the first treatment specifically developed for ITP. It
is also being investigated for potential use in pediatric ITP,
myelodysplastic syndrome (MDS) and chemotherapy-induced
thrombocytopenia (CIT).

Important EU Nplate Safety Information

The most common side effects are headache, fatigue, arthralgia,
myalgia, injection site bruising, injection site pain, oedema
peripheral, dizziness, muscle spasms, nausea, contusion, diarrhea,
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
haematopoietic malignancies or Myelodysplastic Syndromes (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.

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 Myelodysplastic Syndrome
(MDS). Nplate is not indicated for the treatment of thrombocytopenia
due to MDS or any cause of thrombocytopenia other than chronic ITP.

In the U.S. Nplate is available only through a restricted
distribution program called Nplate(TM) NEXUS (Network of Experts
Understanding and Supporting Nplate and Patients) Program.

In the placebo-controlled studies, headache was the most commonly
reported adverse drug reaction.

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 disorder, 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 www.amgen.com.

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CONTACT: Amgen, Thousand Oaks
Sabeena Ahmad, +41-41-3692-530 (EU media, oncology)
Trish Hawkins, +1-805-447-5631 (U.S. media)
Arvind Sood: +1-805-447-1060 (investors)

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ots Originaltext: Amgen
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Contact:
Sabeena Ahmad, +41-41-3692-530 (EU media, oncology), or Trish
Hawkins, +1-805-447-5631 (U.S. media), or Arvind Sood,
+1-805-447-1060 (investors), all of Amgen ;Photo: NewsCom:
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