Amgen Highlights Data To Be Presented At 2013 European Cancer Congress

    Amgen Highlights Data To Be Presented At 2013 European Cancer Congress

PR Newswire

THOUSAND OAKS, Calif., Sept. 12, 2013

THOUSAND OAKS, Calif., Sept. 12, 2013 /PRNewswire/ --Amgen (NASDAQ: AMGN)
today announced that it will present new data from studies of marketed and
pipeline products at the 17th ECCO - 38th ESMO - 32nd ESTRO European Cancer
Congress happening Sept. 27 to Oct. 1 in Amsterdam.

"Amgen's continued focus on growth through innovation is highlighted by the
data that we are presenting at the European Cancer Congress this year," said
Sean E. Harper, M.D., executive vice president of Research and Development at
Amgen. "We are successfully advancing our pipeline, while using cutting-edge
science to better understand each cancer's unique fingerprint and provide
individualized care for patients."

Abstracts are available on the European Cancer Congress website at
http://eccamsterdam2013.ecco-org.eu/.

Data presented on talimogene laherparepvec will include:

  oSecondary Endpoints from OPTiM: A Multicenter, Randomized Phase 3 Trial of
    Talimogene Laherparepvec vs. GM-CSF for the Treatment of Unresected Stage
    IIIB/C and IV Melanoma
    Abstract 3733 / P479, Poster Session, Monday, Sept. 30, 9:30 a.m. - 12:00
    p.m. CEST (Hall 4)

Data presented on trebananib will include:

  oA Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus the
    Angiopoietin 1 and 2 Inhibitor, Trebananib, or Placebo in Women With
    Recurrent Ovarian Cancer: TRINOVA-1
    Abstract 41, Late Breaking Abstract, Proffered Papers Session, Tuesday,
    Oct. 1, 10:53 - 11:05 a.m. CEST (Hall 7.2)

Data presented on Vectibix^® (panitumumab) will include:

  oASPECCT: A Randomized, Multicenter, Open-Label, Phase 3 Study of
    Panitumumab vs. Cetuximab for Previously Treated Wild-Type KRAS Metastatic
    Colorectal Cancer
    Abstract 18, Late Breaking Abstract, Proffered Papers Session, Saturday,
    Sept. 28, 1:47 - 2:10 p.m. CEST (RAI Auditorium)
  oTumor Genetic Analysis of PRIME: KRAS, NRAS, and BRAF Mutations as
    Predictive Biomarkers in Patients with Metastatic Colorectal Cancer
    Receiving First-Line Treatment With Panitumumab Plus FOLFOX4
    Abstract 2275 / P157, Poster Session, Sunday, Sept. 29, 2:00 - 4:30 p.m.
    CEST (Hall 4)
  oUpdated Overall Survival Analysis of Novel Predictive KRAS/NRAS Mutations
    Beyond KRAS Exon 2 in PEAK: A First-Line Phase 2 Study of FOLFOX6 plus
    Panitumumab or Bevacizumab in Metastatic Colorectal Cancer
    Abstract 2262 / P144, Poster Session, Sunday, Sept. 29, 2:00 - 4:30 p.m.
    CEST (Hall 4)

About Talimogene Laherparepvec
Talimogene laherparepvec is an investigational oncolytic immunotherapy
designed to selectively replicate in tumor tissue. Talimogene laherparepvec is
injected directly into tumor tissue and then replicates until the membrane of
the cancer cells rupture, thereby destroying the cells, in a process known as
cell lysis. The virus that was contained in these cells is then released
locally in the tumor tissue along with potential tumor antigens and GM-CSF, a
white blood cell growth factor that the virus is engineered to express. This
is intended to lead to the activation of a systemic immune response to kill
tumor cells throughout the body.

About Trebananib
Trebananib is an investigational peptibody designed to inhibit the
angiopoietin axis. The angiopoietin axis is involved in angiogenesis, a
process used by the body to grow new blood vessels, which is also involved in
the pathogenesis of several diseases including cancer. Trebananib is designed
to bind to both angiopoietin-1 and -2 (Ang1 and Ang2), and is intended to
inhibit their interaction with the Tie2 receptor.^1,2,3 Ang1 and Ang2 each
mediate separate actions upon binding with Tie2.^4,5 Ang1 impacts vessel
quality while Ang2 influences vessel quantity. The angiopoietins are also
involved in lymphangiogenesis, the formation of new lymphatic vessels, which
plays a key role in tumor metastasis.^6

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 metastatic colorectal
cancer (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.

Vectibix is not indicated for the treatment of patients with KRAS
mutation-positive mCRC or for whom KRAS mCRC status is unknown. Vectibix in
combination with oxaliplatin-based chemotherapy is not indicated for the
treatment of patients with RAS (KRAS or NRAS) mutation-positive mCRC or for
whom RAS status is unknown.

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)KRASafter
failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing
chemotherapy regimens. In July 2013, the indication was updated to the
following:

Vectibix is indicated for the treatment of adult patients with wild-type RAS
mCRC:

  oin first-line in combination with FOLFOX.
  oin second-line in combination with FOLFIRI for patients who have received
    first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
  oas monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and
    irinotecan-containing chemotherapy regimens.

Vectibix is approved in over 50 countries worldwide.

Important U.S. Product Information
Vectibix is indicated as a single agent for the treatment of EGFR-expressing
mCRC with 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 demonstrate an improvement in
disease-related symptoms or increased survival with Vectibix.

Vectibix is not indicated for the treatment of patients with KRAS
mutation-positive mCRC or for whom KRAS mCRC status is unknown. Retrospective
subset analyses of metastatic colorectal cancer trials have not shown a
treatment benefit for Vectibix in patients whose tumors had KRAS mutations in
codon 12 or 13. Vectibix in combination with oxaliplatin-based chemotherapy is
not indicated for the treatment of patients with RAS (KRAS or NRAS)
mutation-positive mCRC or for whom RAS status is unknown.

WARNING: DERMATOLOGIC TOXICITY and INFUSION REACTIONS
Dermatologic Toxicity: Dermatologic toxicities occurred in 89 percent of
patients and were severe (NCI-CTC grade 3 or higher) in 12 percent of patients
receiving Vectibix monotherapy. [See Dosage and Administration (2.1), Warnings
and Precautions (5.1), and Adverse Reactions (6.1)].

Infusion Reactions: Severe infusion reactions occurred in approximately one
percent of patients. Fatal infusion reactions occurred in postmarketing
experience [See Dosage and Administration (2.1), Warnings and Precautions
(5.2), and Adverse Reactions (6.1, 6.3)].

The most common adverse events of Vectibix are skin rash with variable
presentations, hypomagnesemia, paronychia, fatigue, abdominal pain, nausea and
diarrhea, including diarrhea resulting in dehydration.

The most serious adverse reactions of Vectibix are pulmonary fibrosis,
pulmonary embolism, severe dermatologic toxicity complicated by infectious
sequelae and septic death, infusion reactions, abdominal pain, hypomagnesemia,
nausea, vomiting and constipation.

Important European Product Safety Information

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

Vectibix is indicated for the treatment of adult patients with wild-type RAS
metastatic colorectal cancer (mCRC):

  oin first-line in combination with FOLFOX.
  oin second-line in combination with FOLFIRI for patients who have received
    first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
  oas monotherapy 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.

The combination of Vectibix with oxaliplatin-containing chemotherapy is
contraindicated for patients with mutant RAS mCRC or for whom RAS mCRC status
is unknown

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.

About Amgen
Amgen is committed to unlocking the potential of biology for patients
suffering from serious illnesses by discovering, developing, manufacturing and
delivering innovative human therapeutics. This approach begins by using tools
like advanced human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics
manufacturing expertise to strive for solutions that improve health outcomes
and dramatically improve people's lives. A biotechnology pioneer since 1980,
Amgen has grown to be the world's largest independent biotechnology company,
has reached millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.

For more information, visit www.amgen.com and 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 any
subsequent 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. 12, 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 product liability claims. If we fail to meet the compliance
obligations in the corporate integrity agreement between us and the U.S.
government, we could become subject to significant sanctions. 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 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 labeling approved by the FDA for the products. The products are not
approved for theinvestigational use(s) discussed in this news release, and no
conclusions can or should be drawn regarding the safety or effectiveness of
the products for theseuses. Only the FDA can determine whether the products
are safe and effective for these uses. Healthcareprofessionals shouldrefer
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, 805-447-5476 (media)
Arvind Sood, 805-447-1060 (investors)

^1 Herbst R.S., Expert Opin Emerg Drugs. 2006;11:635-650.
^2 Carmeliet P., Jain R.K., Nature. 2000;407:249-257.
^3 Folkman J., Nat Rev Drug Discov. 2007;6:273-286.
^4 Falcon B.L., Hashizume H., Koumoutsakos P., et al., Am J Pathol.
2009;175:2159–2170.
^5 Ahmad S.A., Liu W., Jung Y.D., et al., Cancer Res. 2001;61:1255-1259.
^6 Huang H., Bhat A., Woodnutt G., et al., Nat Rev Cancer. 2010;10:575-585.

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SOURCE Amgen

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