Nplate(R) Approved in the European Union for the Treatment of Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Zug, Switzerland (ots/PRNewswire) -

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

Amgen (Nasdaq: AMGN) today announced that the European Commission
(EC) has granted marketing authorisation for Nplate(R) (romiplostim)
for the treatment of splenectomised adult chronic immune (idiopathic)
thrombocytopenic purpura (ITP) patients who are refractory to other
treatments (e.g. corticosteroids, immunoglobulins). Nplate may be
considered as second line treatment for adult non-splenectomised ITP
patients where surgery is contra-indicated.

Nplate, the first and only approved platelet producer in Europe,
has been granted marketing authorisation for the European Union (EU)
based upon a positive opinion from the European Committee for
Medicinal Products for Human Use in November 2008. Nplate works by
raising and sustaining platelet counts, representing a novel approach
for the long-term treatment of this chronic disease.

Chronic ITP is a serious autoimmune disorder characterised by low
platelet counts in the blood (thrombocytopenia), which can lead to
serious bleeding events. ITP is recognised as an orphan disease by
the European Medicines Agency (EMEA) and there are an estimated
50,000 adult patients with chronic ITP in the EU.(1) Nplate is a
breakthrough thrombopoiesis-stimulating peptibody that represents a
new approach to the management of ITP by increasing platelet
production and potentially reducing the need for rescue and other
maintenance medications.

"Nplate is the first approved long-term treatment option in
Europe that specifically targets platelet production," said Dr
Roberto Stasi, Department of Medical Sciences, Regina Apostolorum
Hospital, Italy. "Although ITP affects a limited patient population,
it can have a significant impact on patient lives. Nplate represents
a potentially high value option for these patients."

The EU approval of Nplate 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 medications such as corticosteroids
which are often not well tolerated. Nplate patients also used far
less "emergency" medications such as IVIG and Win-Rho, whose effects
are transient.

Upon completion of the Phase 3 studies almost 90 percent of
patients elected to subsequently enroll into the Nplate long term
extension study which demonstrated that Nplate continued to
effectively increase and sustain platelet counts. In this open label
long term extension study the average treatment period was 76 weeks
and the longest duration of treatment was 204 weeks.

Key findings from the extension study showed platelet counts of
Nplate-treated patients were increased from baseline by 20,000
platelets per microliter more than 80 percent of the time in 47
percent of patients and more than half the time in 67 percent of
patients.

"Amgen is committed to advancing the discovery and development of
new therapies for grievous illnesses where there is an unmet need,"
said Willard Dere, M.D., senior vice president and international
chief medical officer at Amgen. "The European approval of Nplate is
the result of more than 15 years of research and represents an
important biotechnology milestone as it is the first approved
peptibody, an innovative platform for delivering targeted therapies."

About Adult ITP

In patients with 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 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. 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 paediatric ITP,
myelodysplastic syndromes (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, peripheral
oedema, 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
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 haematological
malignancies and progression of malignancy in patients with a
pre-existing haematological malignancy or myelodysplastic syndromes
(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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(1) Gernsheimer. T, Epidemiology and pathophysiology of immune
thrombocytopenic purpura. European Journal of Haematology. 2008;
80:3-8

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CONTACT: Amgen, Thousand Oaks
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Trish Hawkins, +1-805-447-5631 (U.S. media)
Arvind Sood: +1-805-447-1060 (investors)

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