New Study Shows Nplate(R) Significantly Reduces Splenectomy Rate and Treatment Failure in Patients With Chronic ITP

Berlin (ots/PRNewswire) -

Amgen Inc. (Nasdaq: AMGN) today released the results of a new
study comparing Nplate(R) (romiplostim) to the medical standard of
care (SOC) in non-splenectomised adult patients with chronic immune
thrombocytopenic purpura (ITP). Chronic ITP is a serious autoimmune
disorder characterised by low platelet counts in the blood
(thrombocytopenia), which can lead to serious bleeding events. The
study results show Nplate significantly reduced the incidences of
splenectomy and treatment failures in non-splenectomised adult
patients with chronic ITP when compared to medical SOC. The results
were presented today as an oral presentation at the 14th congress of
the European Hematology Association (EHA abstract #1672).

"In this study, patients receiving Nplate experienced significant
clinical efficacy benefits, including a reduction in bleeding events,
compared to the standard of care," said Dr. Mathias Rummel, head of
hematology at the Hospital of the Justus-Liebig University, Giessen,
Germany. "Nplate is a unique treatment option that can help us better
manage patients with chronic ITP. It addresses an unmet medical need
for our patients as it increases platelet production and avoids
immune suppression."

The study results show that only 8 percent of Nplate patients
(13/157) underwent splenectomy or discontinued the study prior to
reporting a splenectomy compared with 35 percent of patients (27/77)
in the SOC group. Furthermore, 12 percent of Nplate patients (19/157)
experienced treatment failure or discontinued the study compared with
27 percent of the SOC patients (21/77). Treatment failures were
defined as patients having platelet counts less than or equal to
20,000 platelets per microliter for four consecutive weeks at the
highest recommended dose and schedule, a major bleeding event, and/or
a change in therapy due to intolerable side effects or bleeding
symptoms. Patients who changed their therapy to splenectomy due to
intolerable side-effects or bleeding symptoms were counted as both
treatment failures and splenectomies.

A secondary analysis excluding patients who discontinued the
study showed a similar trend in the reduction in splenectomy and
treatment failure in the Nplate group compared to the SOC group. Only
1 percent of Nplate patients (2/157) underwent a splenectomy compared
with 19 percent of SOC patients (15/77). Additionally, 5 percent of
Nplate patients (8/157) experienced treatment failure compared to 12
percent of SOC patients (9/77).

The study also showed that the safety profile was comparable
between the Nplate group and the group receiving the SOC. The safety
analyses included all patients who received greater than or equal to
1 dose of Nplate or one type of SOC for ITP. Bleeding events with
grade greater than or equal to 3 severity were reported by 8 percent
of patients (6/75) in the SOC group, compared with 3 percent in the
Nplate group (5/154).

About the Study

In total, 234 patients enrolled in this study, which assessed the
efficacy and safety of Nplate compared to the medical SOC in adult
patients with chronic ITP. SOC treatments were prescribed by the
investigator according to standard institutional practices or
therapeutic guidelines; the only treatments not allowed were
investigational agents (rituximab was allowed) or other
thrombopoietic agents.

Adverse events (AEs) were experienced by 92 percent of patients
receiving the SOC (69/75) and by 95 percent of patients (146/154)
receiving Nplate. The most common AEs in the SOC group were epistaxis
(23 percent), nasopharyngitis (19 percent), and contusion (19
percent); in the Nplate group the most common AEs were headache (35
percent), fatigue (27 percent), and nasopharyngitis (23 percent).
Treatment-related serious AEs were reported by 8 percent of SOC
(6/75) and 5 percent of Nplate patients (7/154).

About Adult Chronic 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
can increase when platelet counts drop to less than 30,000 platelets
per microlitre; normal counts range from 150,000 to 400,000 platelets
per microlitre. ITP has historically been considered a disease of
platelet destruction although recent data suggest that the body's
natural platelet production processes in chronic 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 (e.g., corticosteroids,
immunoglobulins and others) 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
140,000 treated chronic ITP patients in Europe (EU) and the United
States (U.S.). Chronic ITP affects about twice as many adult women as
men.

About Nplate

In Europe, Nplate is indicated 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 a
second-line treatment for adult non-splenectomised ITP patients for
whom surgery is contra-indicated.

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.

Nplate was the first platelet producer approved for chronic ITP
by the regulatory bodies in Australia, the EU, Canada, and the U.S.,
and is under review in Switzerland. 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 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.

Recurrence 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.

For full prescribing information please see the Summary of
Product Characteristics.

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, 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.

CBCs, including platelet counts and peripheral blood smears,
should be monitored prior to initiation, throughout, and following
discontinuation of Nplate therapy.

Nplate is available only through a restricted distribution
program called Nplate(R) 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.

Forward-Looking Statement

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 results to differ materially from those described.
All statements, other than statements of historical fact, are
statements that could be deemed forward-looking statements, including
estimates of revenues, operating margins, capital expenditures, cash,
other financial metrics, expected legal, arbitration, political,
regulatory or clinical results or practices, customer and prescriber
patterns or practices, reimbursement activities and outcomes and
other such estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed below
and more fully described in the Securities and Exchange Commission
(SEC) reports filed by Amgen, including Amgen's most recent annual
report on Form 10-K and most recent periodic reports on Form 10-Q and
Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and
8-K for additional information on the uncertainties and risk factors
related to our business. Unless otherwise noted, Amgen is providing
this information as of June 7, 2009 and expressly disclaims any duty
to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results
may differ materially from those we project. Discovery or
identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and become
a commercial product. Further, preclinical results do not guarantee
safe and effective performance of product candidates in humans. The
complexity of the human body cannot be perfectly, or sometimes, even
adequately modelled by computer or cell culture systems or animal
models. The length of time that it takes for us to complete clinical
trials and obtain regulatory approval for product marketing has in
the past varied and we expect similar variability in the future. We
develop product candidates internally and through licensing
collaborations, partnerships and joint ventures. Product candidates
that are derived from relationships may be subject to disputes
between the parties or may prove to be not as effective or as safe as
we may have believed at the time of entering into such relationship.
Also, we or others could identify safety, side effects or
manufacturing problems with our products after they are on the
market. Our business may be impacted by government investigations,
litigation and products liability claims. We depend on third parties
for a significant portion of our manufacturing capacity for the
supply of certain of our current and future products and limits on
supply may constrain sales of certain of our current products and
product candidate development.

In addition, sales of our products are affected by the
reimbursement policies imposed by third-party payors, including
governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
healthcare cost containment as well as U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government and others'
regulations and reimbursement policies may affect the development,
usage and pricing of our products. In addition, we compete with other
companies with respect to some of our marketed products as well as
for the discovery and development of new products. We believe that
some of our newer products, product candidates or new indications for
existing products, may face competition when and as they are approved
and marketed. Our products may compete against products that have
lower prices, established reimbursement, superior performance, are
easier to administer, or that are otherwise competitive with our
products. In addition, while we routinely obtain patents for our
products and technology, the protection offered by our patents and
patent applications may be challenged, invalidated or circumvented by
our competitors and there can be no guarantee of our ability to
obtain or maintain patent protection for our products or product
candidates. We cannot guarantee that we will be able to produce
commercially successful products or maintain the commercial success
of our existing products. Our stock price may be affected by actual
or perceived market opportunity, competitive position, and success or
failure of our products or product candidates. Further, the discovery
of significant problems with a product similar to one of our products
that implicate an entire class of products could have a material
adverse effect on sales of the affected products and on our business
and results of operations.

The scientific information discussed in this news release related
to our product candidates is preliminary and investigative. Such
product candidates are not approved by the U.S. Food and Drug
Administration (FDA), and no conclusions can or should be drawn
regarding the safety or effectiveness of the product candidates. Only
the FDA can determine whether the product candidates are safe and
effective for the use(s) being investigated. Further, the scientific
information discussed in this news release relating to new
indications for our products is preliminary and investigative and is
not part of the labelling approved by the FDA for the products.

The products are not approved for the investigational use(s)
discussed in this news release, and no conclusions can or should be
drawn regarding the safety or effectiveness of the products for these
uses. Only the FDA can determine whether the products are safe and
effective for these uses. Healthcare professionals should refer to
and rely upon the FDA-approved labelling for the products, and not
the information discussed in this news release.

CONTACT: Amgen, Thousand Oaks
Sabeena Ahmad, +41-41-3692-530 (EU media, oncology)
Ashleigh Koss, +1-805-313-6151 (US media)
Arvind Sood: +1-805-447-1060 (investors)

(Logo: http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO)

ots Originaltext: Amgen Inc.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Sabeena Ahmad, +41-41-3692-530, EU media, oncology, of Amgen, or US
media, Ashleigh Koss, +1-805-313-6151, or investors, Arvind Sood,
+1-805-447-1060, both of Amgen, Thousand Oaks; Photo:
http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO