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Amgen Announces Results From Phase 3 PAVES Study Evaluating Neulasta® (pegfilgrastim) In Patients With Colorectal Cancer

    Amgen Announces Results From Phase 3 PAVES Study Evaluating Neulasta®
              (pegfilgrastim) In Patients With Colorectal Cancer

Study Shows Neulasta Reduced the Incidence of Febrile Neutropenia in Patients
With Colorectal Cancer Receiving FOLFOX or FOLFIRI and Bevacizumab

PR Newswire

THOUSAND OAKS, Calif., Jan. 26, 2013

THOUSAND OAKS, Calif., Jan. 26, 2013 /PRNewswire/ -- Amgen (NASDAQ:AMGN)
announced today results from Pegfilgrastim and Anti-VEGF Evaluation Study
(PAVES), a Phase 3 trial which evaluated Neulasta^® (pegfilgrastim) in 845
patients receiving FOLFOX or FOLFIRI and bevacizumab for the first-line
treatment of locally-advanced or metastatic colorectal cancer. FOLFOX and
FOLFIRI are two of the most commonly used chemotherapy regimens for colorectal
cancer.

The study met its primary endpoint, with Neulasta significantly reducing the
incidence of febrile neutropenia. Febrile neutropenia is a low white blood
cell count accompanied by a fever.^1 In the study, the incidence of grade 3 or
4 febrile neutropenia in patients receiving Neulasta across the first four
cycles of chemotherapy was 2.4 percent compared to 5.7 percent in the placebo
group (OR=0.41, p=0.014). A similar incidence of grade 3 or higher adverse
events was seen in both arms of the trial (28 percent placebo; 27 percent
Neulasta).

"This analysis showed that PAVES met its primary endpoint, with Neulasta
significantly reducing the incidence of febrile neutropenia in patients with
colorectal cancer," said Sean E. Harper, M.D., executive vice president of
Research and Development at Amgen."In addition to providing new data on
Neulasta, we believe PAVES will provide valuable information to the oncology
community on commonly-used chemotherapy regimens."

Full results will be presented on Saturday, Jan. 26 during the 2013
Gastrointestinal Cancers Symposium, General Poster Session C (C1) by Tamas
Pinter, M.D., the PAVES principal investigator, Aladar Korhaz Hospital,
Onkoradiologiai Osztaly, Gyor, Hungary (Late Breaking Abstract No. 445).

Follow-up results of PAVES looking at additional endpoints, including mature
data on overall survival, overall response rate, time to progression and
progression-free survival, will be presented at a future date.

About PAVES

PAVES is a Phase 3, randomized, double-blind, placebo-controlled trial
evaluating Neulasta in 845 patients receiving FOLFOX or FOLFIRI and
bevacizumab for the first-line treatment of locally-advanced or metastatic
colorectal cancer. The trial was multicenter and multinational. All patients
received treatment with either FOLFOX or FOLFIRI plus bevacizumab and were
randomized to one of two treatment arms that also received either placebo or 6
mg of Neulasta at least 24 hours after each cycle of chemotherapy. The primary
endpoint was the incidence of grade 3 or 4 febrile neutropenia during the
first four cycles. The study was not designed to define the febrile
neutropenia rate of FOLFOX or FOLFIRI plus bevacizumab. Other endpoints
include overall response rate, progression-free survival, overall survival,
time to progression and adverse events.

About Febrile Neutropenia

One of the most common side effects of myelosuppressive chemotherapy is a low
white blood cell count.^2 An abnormally low level of neutrophils, an important
infection-fighting white blood cell, is called neutropenia.^2 The fewer
neutrophils a patient has – and the longer the neutrophil count remains low –
the greater the risk of developing a potentially serious infection.^2, 3

Febrile neutropenia is neutropenia complicated by a fever.^1 Fever is
frequently a sign of infection and, in patients receiving myelosuppressive
chemotherapy, it can sometimes be the only sign.^2 Febrile neutropenia is a
medical emergency and is associated with several potential downstream
consequences.^2, 4

About Neulasta

Neulasta was approved by the U.S. Food and Drug Administration (FDA) in 2002
to decrease the incidence of infection, as manifested by febrile neutropenia,
in patients with nonmyeloid malignancies receiving myelosuppressive anticancer
drugs associated with a clinically significant incidence of febrile
neutropenia.^5 Neulasta is not indicated for the mobilization of peripheral
blood progenitor cells for hematopoietic stem cell transplantation.

Important Safety Information

Do not administer Neulasta to patients with a history of serious allergic
reactions to pegfilgrastim or Filgrastim.

Fatal splenic rupture can occur. Evaluate for splenomegaly or splenic rupture
in patients with left upper abdominal or shoulder pain. Acute respiratory
distress syndrome (ARDS) can occur. Evaluate for ARDS in patients who develop
fever, lung infiltrates, or respiratory distress. Discontinue Neulasta in
patients with ARDS. Serious allergic reactions, including anaphylaxis, can
occur. Permanently discontinue Neulasta in patients with serious allergic
reactions. Severe and sometimes fatal sickle cell crises have been reported.

Most common adverse reactions (≥ 5% difference in incidence) in
placebo-controlled clinical trials are bone pain and pain in extremity.

To see the full Neulasta Safety Information, visit
www.amgen.com/medpro/products.html.

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, 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 our vital medicines, visit www.amgen.com. Follow us on
www.twitter.com/amgen.

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 Jan. 26, 2013, 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 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 relating to new
indications for our products is preliminary and investigative and is not part
of the labeling approved by the U.S. Food and Drug Administration (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
Ashleigh Koss, 805-313-6151 (media)
Arvind Sood, 805-447-1060 (investors)

^1 Dictionary of Cancer Terms: Febrile Neutropenia. National Cancer Institute
website. Available at www.cancer.gov/dictionary?CdrID=415543. Accessed January
7, 2013.
^2 "Chemotherapy and You" brochure. National Cancer Institute website.
www.cancer.gov/cancertopics/coping/chemotherapy-and-you/page7#SE8. Accessed
January 7, 2013.
^3 Bodey GP, et al. Ann Intern Med. 1966;64: 328–340.
^4 Kuderer N, et al. Cancer. 2006: 2006;106:2258–66.
^5 Neulasta^® (pegfilgrastim) prescribing information, Amgen.

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

SOURCE Amgen

Website: http://www.amgen.com
 
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