Amgen Announces Top-Line Results Of Phase 3 Trebananib (AMG 386) TRINOVA-1 Trial In Recurrent Ovarian Cancer

  Amgen Announces Top-Line Results Of Phase 3 Trebananib (AMG 386) TRINOVA-1
                      Trial In Recurrent Ovarian Cancer

Study Meets Primary Endpoint of Progression-Free Survival

PR Newswire

THOUSAND OAKS, Calif., June 12, 2013

THOUSAND OAKS, Calif., June 12, 2013 /PRNewswire/ -- Amgen (NASDAQ: AMGN)
today announced that the Phase 3 TRINOVA-1 trial evaluating trebananib plus
paclitaxel versus placebo plus paclitaxel in recurrent ovarian cancer met its
primary endpoint of progression-free survival (PFS). A statistically
significant difference was observed in PFS with a 34 percent reduction in the
risk of disease progression or death (HR = 0.66, 95 percent CI, 0.57, 0.77,
p<0.001). The median PFS was 7.2 months in the trebananib arm versus 5.4
months in the control arm.

The primary analysis of overall survival (OS), a key secondary endpoint, is
expected to mature in 2014 in line with previous guidance. Although an early
imbalance of deaths favoring the control arm was observed, there was an
overall favorable OS trend for trebananib in a pre-planned interim analysis.

"The TRINOVA-1 study is the first of three Phase 3 trials designed to evaluate
the safety and efficacy of trebananib in patients with ovarian cancer," said
Sean E. Harper, M.D., executive vice president of Research and Development at
Amgen. "Angiopoietin inhibition has been a focus of research at Amgen and
these results suggest that the novel biology of trebananib may offer a
promising approach for patients with ovarian cancer."

In the trebananib arm, the most frequently reported adverse events were
localized edema, nausea and alopecia. The rate of discontinuation of
investigational product due to adverse events was 20 percent in the trebananib
arm versus seven percent in the control arm.

Approximately 22,240 new cases of ovarian cancer will be diagnosed in the
United States in 2013.^1 More than 70 percent of women with ovarian cancer
will present with advanced disease at diagnosis and up to 80 percent of them
will experience disease recurrence and eventually die from their disease.^2,3

TRINOVA-1 Trial Design (NCT01204749)
TRINOVA-1 is a Phase 3 global, multicenter, randomized, double-blind,
placebo-controlled study evaluating trebananib in over 900 women with
recurrent partially platinum-sensitive or-resistant (platinum-free interval
of 12 months or less) epithelial ovarian, primary peritoneal or fallopian tube
cancer. Patients were randomized 1:1 to receive either 15 mg/kg of intravenous
trebananib weekly plus 80 mg/m^2 of intravenous paclitaxel weekly (three weeks
on, one week off) or weekly intravenous placebo plus 80 mg/m^2 of intravenous
paclitaxel weekly (three weeks on, one week off).

Other ongoing Phase 3 studies of trebananib include TRINOVA-2 and TRINOVA-3.
TRINOVA-2 is evaluating whether trebananib plus pegylated liposomal
doxorubicin (PLD) is superior to placebo plus PLD as measured by PFS in
recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer.
TRINOVA-3 is evaluating trebananib or placebo in combination with paclitaxel
and carboplatin in the first-line treatment of epithelial ovarian, primary
peritoneal or fallopian tube cancer.

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. Trebananib is designed to bind to both
angiopoietin-1 and -2 (Ang1 and Ang2), and inhibit their interaction with the
Tie2 receptor.^4,5,6 Ang1 and Ang2 each mediate separate actions upon binding
with Tie2.^7,8 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.^9

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 people around the world in the fight
against serious illnesses. With a deep and broad pipeline of potential new
medicines, Amgen remains committed to advancing science to dramatically
improve people's lives. 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 June 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
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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
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safety, side effects or manufacturing problems with our products after they
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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
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In addition, sales of our products are affected by the reimbursement policies
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The scientific information discussed in this news release related to our
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conclusions can or should be drawn regarding the safety or effectiveness of
the product candidates. Only the FDA can determine whether the product
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Healthcareprofessionals shouldrefer to and rely upon the FDA-approved
labeling for the products, and not the information discussed in this news
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CONTACT: Amgen, Thousand Oaks
Christine Regan, 805-447-5476 (media)
Arvind Sood, 805-447-1060 (investors)

References

^1 Ovarian Cancer Key Statistics, American Cancer Society website. Available
at:
http://www.cancer.org/Cancer/OvarianCancer/DetailedGuide/ovarian-cancer-key-statistics.
Accessed March 26, 2013.
^2 Martin L.P., Semin Oncol. 2009.
^3 NCCN Ovarian Cancer 2013 Guidelines.
^4 Herbst R.S., Expert Opin Emerg Drugs. 2006;11:635-650.
^5 Carmeliet P., Jain R.K., Nature. 2000;407:249-257.
^6 Folkman J., Nat Rev Drug Discov. 2007;6:273-286.
^7 Falcon B.L., Hashizume H., Koumoutsakos P., et al., Am J Pathol.
2009;175:2159–2170.
^8 Ahmad S.A., Liu W., Jung Y.D., et al., Cancer Res. 2001;61:1255-1259.
^9 Huang H., Bhat A., Woodnutt G., et al., Nat Rev Cancer. 2010;10:575-585.

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