Vectibix(R) in Combination With Chemotherapy Significantly Improves Progression-Free Survival in Second-Line Metastatic Colorectal Cancer

Thousand Oaks, California (ots/PRNewswire) -

Amgen (Nasdaq: AMGN) today announced detailed results from the
Phase 3 '181' trial evaluating Vectibix(R) (panitumumab) in
combination with FOLFIRI (an irinotecan based chemotherapy), as a
second-line treatment for metastatic colorectal cancer (mCRC). In
this trial, Vectibix significantly improved progression-free survival
(PFS) in patients with KRAS wild-type mCRC. These results were
presented at the 2009 ECCO 15 - ESMO 34 European Multidisciplinary
Congress in Berlin, Germany (Abstract Number 14LBA).

The addition of Vectibix to FOLFIRI significantly improved median
PFS (co-primary endpoint) by two months (5.9 versus 3.9 months for
patients treated with FOLFIRI alone, hazard ratio 0.73, p=0.004) in
patients with KRAS wild-type mCRC. Although numerically greater (14.5
months versus 12.5 months; hazard ratio 0.85), the improvement in
median overall survival (co-primary endpoint) in the Vectibix arm did
not achieve statistical significance (p=0.115) in the same patient
population.

Further, the addition of Vectibix to FOLFIRI resulted in greater
than a three-fold improvement (35 percent versus 10 percent) in
response rate in the KRAS wild-type patient population as measured by
a blinded central review.

"This study showed that Vectibix can be safely administered in
combination with FOLFIRI chemotherapy. Vectibix delayed disease
progression by more than half compared to FOLFIRI alone in patients
with previously treated KRAS wild-type colorectal cancer," said Marc
Peeters, M.D., Ph.D., coordinator of Digestive Oncology Unit,
University Hospital Ghent and the study's principal investigator.
"Further, the response rate seen in this trial is among the highest
ever reported in the second-line metastatic CRC setting."

In general, adverse events rates were comparable across arms with
the exception of known toxicities associated with anti-epidermal
growth factor receptor (EGFR) therapy such as rash, diarrhea, and
hypomagnesemia. Vectibix-related grade 3/4 infusion reactions were
reported in less than one percent of patients.

There were no differences in progression-free survival, overall
survival and response rates among patients with mutated KRAS who
received Vectibix.

Originally designed to compare the treatment effect in the
overall population, the study was amended to analyze outcomes with
respect to the presence or absence of activating mutations in KRAS in
the tumor itself. Tumor KRAS status was ascertained in 91 percent of
the 1,186 patients enrolled in this trial, the highest number ever
reported for a second-line trial.

"These high quality prospectively defined analyses prove the
clinical utility of KRAS as a predictive biomarker in metastatic
colorectal cancer patients," added Peeters.

Webcast Information

An analyst/investor event will also be held from the Congress on
September 24th, at 6:30 a.m. Eastern Time to discuss data presented
at ECCO-ESMO. A webcast of the event can be found on Amgen's Web site
at www.amgen.com, under Investors. The audio webcast will be archived
and available for replay for at least 72 hours.

Study Design

The "181" trial is a global, multicenter, randomized Phase 3
study. Patients enrolled in the study were randomized to receive
either 6.0 mg/kg of Vectibix and FOLFIRI every two weeks (Q2W) or
FOLFIRI alone Q2W. The independently tested co-primary endpoints were
progression-free survival and overall survival. Secondary endpoints
included objective response rate, time to progression, duration of
response and safety by KRAS status.

About KRAS

Results from studies performed over the last twenty-five years
indicate that KRAS plays an important role in cell growth regulation.
In mCRC, EGFR transmits signals through a set of intracellular
proteins. Upon reaching the nucleus, these signals instruct the
cancer cell to reproduce and metastasize, leading to cancer
progression. Anti-EGFR antibody therapies work by blocking the
activation of EGFR, thereby inhibiting downstream events that lead to
malignant signaling. However, it is hypothesized that in patients
whose tumors harbor a mutated KRAS gene, the KRAS protein is always
turned "on," regardless of whether the EGFR has been activated or
therapeutically inhibited. KRAS mutations occur in approximately 40 -
50 percent of mCRC.

About Colorectal Cancer

Colorectal cancer is the fourth most common cancer in men and the
third most common cancer in women worldwide. In 2007, approximately
1.2 million cases of colorectal cancer were expected to occur
globally. With more than 630,000 deaths worldwide per year, it is the
second leading cause of cancer-related death in the Western world.
The highest incidence rates are found in Japan, North America, parts
of Europe, New Zealand, and Australia, and rates are low in Africa
and South-East Asia. Rates are substantially higher in men than in
women.

About Vectibix

Vectibix is the first fully human anti-EGFR antibody approved by
the U.S. Food and Drug Administration (FDA) for the treatment of
mCRC. Vectibix was approved in the United States in September 2006 as
a monotherapy for the treatment of patients with EGFR expressing mCRC
after disease progression on or following fluoropyrimidine-,
oxaliplatin-, and irinotecan-containing chemotherapy regimens.

The effectiveness of Vectibix as a single agent for the treatment
of EGFR-expressing, metastatic colorectal carcinoma is based on
progression-free survival. Currently no data are available that
demonstrate an improvement in disease-related symptoms or increased
survival with Vectibix. Vectibix has not shown a treatment benefit
for patients whose tumors had KRAS mutations in codon 12 or 13.

In December 2007, the EMEA granted a conditional marketing
authorization for Vectibix as monotherapy for the treatment of
patients with EGFR-expressing mCRC with wild-type KRAS genes after
failure of standard chemotherapy regimens. Vectibix has been launched
in over 20 countries, Switzerland, Australia and Canada. Applications
in the rest of the world, including Japan, are pending.

Important Product Safety Information

Dermatologic Toxicity: Dermatologic toxicities occurred in 89
percent of patients and were severe (NCI-CTC grade 3 and higher) in
12 percent of patients receiving Vectibix monotherapy. Withhold
Vectibix for dermatologic toxicities that are grade 3 or higher or
are considered intolerable. If toxicity does not improve to less than
or equal to grade 2 within 1 month, permanently discontinue Vectibix.
The clinical manifestations included, but were not limited to,
dermatitis acneiform, pruritus, erythema, rash, skin exfoliation,
paronychia, dry skin, and skin fissures. Subsequent to the
development of severe dermatologic toxicities, infectious
complications, including sepsis, septic death, and abscesses
requiring incisions and drainage were reported.

Infusion Reactions: Severe infusion reactions occurred in
approximately 1 percent of patients. Severe infusion reactions
included anaphylactic reactions, bronchospasm, and hypotension.
Although not reported with Vectibix, fatal infusion reactions have
occurred with other monoclonal antibody products. Stop infusion if a
severe infusion reaction occurs. Depending on the severity and/or
persistence of the reaction, permanently discontinue Vectibix.

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 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 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 Sept. 22, 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 modeled 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 health
care 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
relating to new indications for our products is preliminary and
investigative and is not part of the labeling 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 labeling for the products,
and not the information discussed in this news release.

CONTACT: Amgen, Thousand Oaks
Christine Regan: +1-805-447-5476 (media U.S.)
Wendy Woods: +41(0)41-3692-542 (media Europe)
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:
media U.S., Christine Regan, +1-805-447-5476, or media Europe, Wendy
Woods, +41(0)41-3692-542, or investors, Arvind Sood, +1-805-447-1060,
all of Amgen, Thousand Oaks /
http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO