Amgen Statement on CHMP Opinion on Vectibix(R) (Panitumumab) Use With Chemotherapy in Metastatic Colorectal Cancer

Thousand Oaks, California (ots/PRNewswire) - Amgen
today issued the following statement:

Amgen has received notice that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA)
has adopted a negative opinion for Amgen's application to extend the
marketing authorization in Europe for Vectibix(R) (panitumumab) to
include combination with chemotherapy for the treatment of patients
with wild-type KRAS metastatic colorectal cancer (mCRC).

Amgen will review the CHMP opinion and consider appropriate next
steps, as Amgen believes that Vectibix in combination with
chemotherapy provides an important treatment option for patients with
wild-type KRAS mCRC. Amgen remains committed to patients with this
aggressive disease, for whom there are limited treatment options.

Vectibix is already approved and established in more than 30
countries outside of the United States (U.S.) as a monotherapy
treatment for patients with wild-type KRAS mCRC, when standard
chemotherapy is no longer effective. In the U.S., Vectibix received
accelerated approval 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. Furthermore, use of
Vectibix is not recommended in patients whose tumors have KRAS
mutations in codon 12 or 13. In Japan and Israel, Vectibix is
approved for use in combination with chemotherapy for patients with
wild-type KRAS mCRC.

Data from studies 20050203 (PRIME) and 20050181 ('181') showed
that adding Vectibix to FOLFOX and FOLFIRI chemotherapy,
respectively, improved progression-free survival (PFS) versus
chemotherapy alone in patients with wild-type KRAS mCRC. Patients
taking this combination have a greater chance of living longer
without their disease getting worse. Additionally, the response rate
of Vectibix plus chemotherapy was higher than chemotherapy alone.
Although numerically greater, the improvement in median overall
survival (OS) did not achieve statistical significance in the
Vectibix arm of either trial.(i)(ii)

In general, adverse events rates were comparable across arms in
both studies, with the exception of known toxicities associated with
anti-EGFR therapy, such as rash, diarrhea, and hypomagnesemia.
Vectibix-related grade 3/4 infusion reactions were reported in less
than one percent of patients. In patients with mutated KRAS tumors,
outcomes were inferior for those receiving Vectibix plus FOLFOX
versus FOLFOX alone. (iii)(iv)

About KRAS

Results from studies performed over the last 25 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.(v)
Anti-EGFR antibody therapies work by inhibiting the activation of
EGFR, thereby inhibiting downstream events that lead to malignant
signaling. However, 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
patients.(vi)(vii)

About Colorectal Cancer

Colorectal cancer is the third most common cancer worldwide in
men and the second most common in women. In 2008, approximately 1.23
million cases of colorectal cancer were diagnosed globally.(viii) In
2008, there were an estimated 333,330 new cases of colorectal cancer
in the EU.(ix)

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 U.S. 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 mCRC is based on progression-free survival.
Currently no data are available that demonstrate an improvement in
disease-related symptoms or increased survival with Vectibix.

Retrospective subset analyses of mCRC trials have not shown a
treatment benefit for Vectibix in patients whose tumors had KRAS
mutations in codon 12 or 13. Use of Vectibix is not recommended for
the treatment of colorectal cancer with these mutations.(x)

In December 2007, the European Medicine Agency (EMA) granted a
conditional marketing authorization for Vectibix as a monotherapy for
the treatment of patients with EGFR-expressing mCRC with non-mutated
(wild-type) KRAS after failure of fluoropyrimidine-, oxaliplatin-,
and irinotecan-containing chemotherapy regimens.(xi) Vectibix has
been launched in more than 30 European Union countries, Russia,
Israel, Switzerland, Australia, Canada and Japan. Applications in the
rest of the world are pending.

Important European Product Safety Information

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

Vectibix is indicated as monotherapy for the treatment of
patients with EGFR-expressing, metastatic colorectal carcinoma (mCRC)
with nonmutated (wild-type) KRAS after failure of fluoropyrimidine-,
oxaliplatin-, and irinotecan-containing chemotherapy regimens.

Vectibix is contraindicated in patients with a history of severe
or life-threatening hypersensitivity reactions to the product and in
patients with interstitial pneumonitis or pulmonary fibrosis.

Other common adverse events of special importance associated with
Vectibix and/or EGFR monoclonal antibody therapies include
dermatologic-related reactions, pulmonary complications, electrolyte
disturbances and infusion-related reactions (including rare reports
with fatal outcome). These events should be monitored carefully, see
Summary of Product Characteristics for information on appropriate
management of these adverse events. Acute renal failure has been
observed in patients who develop severe diarrhoea and dehydration.

Vectibix should not be used in combination with IFL [bolus
5-fluorouracil (500 mg/m2), leucovorin (20 mg/m2) and irinotecan (125
mg/m2)] or in combination with bevacizumab containing chemotherapy.

Vectibix should not be administered in combination with
oxaliplatin-containing chemotherapy to mCRC patients with mutant KRAS
tumours or for whom KRAS tumour status is unknown.

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, 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, bone disease, 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 vital medicines, visit http://www.amgen.com.

Forward-Looking Statements

This statement 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 March 18, 2011 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 payers, 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 statement related to
our product candidates is preliminary and investigative and is not
part of the labeling approved by the U.S. FDA or the European
Medicines Agency (EMA) 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,
EMA or other applicable regulatory bodies can determine whether the
products are safe and effective for these uses. Healthcare
professionals should refer to and rely upon the approved labeling for
the products, and not the information discussed in this statement.

CONTACT: Amgen
Carrie Deverell: +41-41-3690-308 (E.U. media)
Christine Regan: +1-805-447-5476 (U.S. media)
Arvind Sood: +1-805-447-1060 (investors)

(Logo: http://photos.prnewswire.com/prnh/20081015/AMGENLOGO)

(i) Douillard, JE et al. Randomized, Phase 3 Study (PRIME) of
Panitumumab with FOLFOX4 versus FOLFOX4 Alone as First-Line Treatment
in Patients With Previously Untreated Metastatic Colorectal Cancer. J
Clin Oncol 28. 2010.

(ii) Peeters, M et al. Randomized Phase III Study of Panitumumab
With Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) Compared With
FOLFIRI Alone As Second-Line Treatment in Patients With Metastatic
Colorectal Cancer. J Clin Oncol 28, 2010.

(iii) Adverse event 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 infusion reactions were
reported for two patients (less than 1 percent).

(iv) 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.

(v) Malumbres, M. and Barbacid, M. RAS oncogenes: the first 30
years. Nature Reviews Cancer. 3:459-65, 2003.

(vi) Karapentis C, S. Snell, L, E. The Laboratory Assessment of
KRAS Mutation Status in Colorectal Cancer. (http://www.slm-oncology.
com/uploads/media/The_Laboratory_Assessment_of_KRAS_Mutation_Status_i
n_Colorectal_Cancer.pdf) Asia, Pacific Journal of Oncology and
Hematology. 2010.

(vii) Friday BB and Adjei AA. K-ras as a target for cancer
therapy. Biochim. Biophys. Acta 1756: 127-144, 2005.

(viii) Ferlay J, Shin HR, Bray F, Forman D, Mathers C and Parkin
DM. GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide: IARC
CancerBase No. 10. (http://globocan.iarc.fr) Lyon, France:
International Agency for Research on Cancer; 2010.

(ix) Ferlay J, Parkin DM, Steliarova-Foucher E Estimates of
cancer incidence and mortality in Europe in 2008.
(http://www.ncbi.nlm.nih.gov/pubmed/20116997) Eur J Cancer. 2010 Mar;
46(4):765-81. Epub 2010 Jan 29.

(x) Vectibix (panitumumab) [prescribing information]. Thousand
Oaks, Calif: Amgen; 2011.

(xi) Vectibix (panitumumab) SPC. Thousand Oaks, Calif: Amgen;
2011.

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

Contact:
E.U. media, Carrie Deverell, +41-41-3690-308, or U.S. media,Christine
Regan, +1-805-447-5476, or investors, Arvind Sood,+1-805-447-1060,
all of Amgen