Denosumab Demonstrates Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head...

Denosumab Demonstrates Superiority Over Zometa(R) in Pivotal Phase 3
Head-to-Head Trial in Breast Cancer Patients With Bone Metastases
Denosumab Significantly Delayed the Time to the First Skeletal Related Event
and Significantly Reduced First and Subsequent Skeletal Related Events
Compared to Zometa

THOUSAND OAKS, Calif., July 7 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN)
today announced that a pivotal, Phase 3, head-to-head trial evaluating
denosumab versus Zometa(R) (zoledronic acid) in the treatment of bone
metastases in 2,049 patients with advanced breast cancer met its primary and
secondary endpoints and demonstrated superior efficacy compared to Zometa.
Superiority was demonstrated for both delaying the time to the first on-study
Skeletal Related Events (SREs)(fracture, radiation to bone, surgery to bone,
or spinal cord compression) (hazard ratio 0.82, 95 percent CI: 0.71, 0.95),
and delaying the time to the first-and-subsequent SREs (hazard ratio 0.77, 95
percent CI: 0.66, 0.89). Both results were statistically significant.

Overall, the incidence of adverse events and serious adverse events was
consistent with what has previously been reported for these two agents. Of
note, osteonecrosis of the jaw (ONJ), which had not been observed in
previously reported Phase 3 studies with denosumab, was seen infrequently in
both treatment groups. There was no statistically significant difference in
the rate of ONJ between the two treatment arms. Infectious adverse events
were balanced between the two treatment arms, as was overall survival and the
time to cancer progression.

"We are extremely pleased with the outcome of this important study, which
shows that denosumab can reduce or delay the serious complications of bone
metastases in breast cancer patients better than the current standard of care,
and with a favorable benefit/risk profile," said Roger M. Perlmutter, M.D.,
Ph.D., executive vice president of Research and Development at Amgen. "These
results underscore the importance of the RANK Ligand pathway in bone disease,
and offer the promise of improved care for patients with advanced breast
cancer. We look forward to reviewing the results from a second Phase 3 study
of denosumab effects in advanced cancer patients later this year."

Bone metastases, the spread of tumors to the bone, are a serious concern for
advanced breast cancer patients, with incidence rates as high as 75 percent.
When cancer spreads to the bone, the growing cancer cells weaken and destroy
the bone around the tumor. This damage can result in a number of serious bone
complications, collectively called SREs.

Full efficacy and safety data will be submitted for presentation at an
upcoming medical meeting in the second half of this year.

Study Design
This was an international Phase 3, randomized, double-blind study comparing
denosumab with Zometa in the treatment of bone metastases in patients with
advanced breast cancer. Patients enrolled in the study were randomized in a
one-to-one ratio to receive either 120 mg of denosumab subcutaneously every
four weeks (Q4W) or Zometa administered intravenously at a dose of 4 mg
single, 15 minute infusion every four weeks as per the labeled use.

In clinical trials testing new medications for bone metastases, treatment
success has been measured by whether the bone complications, or SREs, caused
by the tumor are reduced or delayed. The primary and secondary endpoints of
the denosumab bone metastases studies use a composite endpoint of four SREs -
fracture, radiation to bone, surgery to bone, and spinal cord compression - to
measure the effectiveness of denosumab versus Zometa.

The primary endpoint was to evaluate if denosumab is non-inferior to Zometa
with respect to the first on-study SRE in patients with advanced breast cancer
and bone metastases. Secondary endpoints were to evaluate if denosumab was
superior to Zometa with respect to the first on-study SRE, as well as
first-and-subsequent on-study SREs, and to assess the safety and tolerability
of denosumab compared with Zometa.

About Denosumab and Amgen's Research in Bone Biology
Denosumab is the first fully human monoclonal antibody in late stage clinical
development that specifically targets RANK Ligand, the essential regulator of
osteoclasts (the cells that break down bone). With more than 19,000 patients
in trials across indications worldwide, the denosumab development program is
the largest ever initiated by Amgen. This broad and deep development program
demonstrates Amgen's commitment to researching and delivering pioneering
medicines to patients with unmet medical needs. Amgen is studying denosumab in
numerous tumor types across the spectrum of cancer induced bone disease. Over
11,000 patients have been enrolled in the denosumab oncology clinical trials
testing the drug for bone loss and destruction associated with cancer
treatment-induced bone loss in breast and prostate cancers, for the prevention
of skeletal related events due to the spread of cancer to the bone in multiple
myeloma and multiple solid tumors, and for its potential to delay bone
metastases in prostate cancer.

Bone Metastases: Impact and Prevalence
Bone metastases, cancer cells that separate from tumors and migrate to bone
tissue where they settle and grow, occur in more than 1.5 million people
worldwide.(1) With improvements in cancer care, including earlier diagnosis
and new treatment options, leading to increases in survival rates(2), the
number of patients developing metastatic disease secondary to a primary cancer
is increasing. Bone metastases are a significant problem for patients with
certain types of advanced cancer, with incidence rates of nearly 100 percent
in myeloma patients and as high as 75 percent in breast and prostate cancer
patients.

With bone metastases the growing cancer cells weaken and destroy the bone
around the tumor. The damage the tumor has caused to the bone can result in a
number of serious complications, collectively called skeletal related events
(SREs). These include fracture of a bone, radiation to bone, surgery to bone,
or spinal cord compression. All are serious complications for advanced cancer
patients.

The economic burden of U.S. patients with bone metastases is significant and
was estimated to be $12.6 billion last year.(3) Patients with bone metastases
who experience an SRE incur significantly higher medical costs compared with
those who do not experience an SRE.(4)

About Amgen
Amgen discovers, develops 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
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other such estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed below and more
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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 July 7, 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
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produce commercially successful products or maintain the commercial success of
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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 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.

ZOMETA is a registered trademark of Novartis Oncology.

*Editors Note: The FDA has provisionally approved the trade name Prolia(TM)
for the proposed indications of treatment and prevention of osteoporosis in
postmenopausal women, and treatment and prevention of bone loss in patients
undergoing hormone ablation for non-metastatic prostate or breast cancer, for
which denosumab is administered twice yearly subcutaneously at a 60 mg dose.
The Prolia(TM) trade name is only for these indications and may not apply for
other indications of denosumab.

(1) Capanna R, Coia LR, Coleman R. et al. eds. Textbook of Bone Metastases.
Hoboken, NJ: Edition: John Wiley and Sons; 2005:105.
(2) Mundy GR. Metastasis to bone: causes, consequences and therapeutic
opportunities. Nat Rev Cancer. 2002 Aug;2(8):584-93.
(3) Schulman K and Kohles J. Cancer. 2007;109:2334-2342
(4) GVD/Barber ISPOR 2008 Poster; Schulman 2007; Delea et al. 2006

Amgen, Thousand Oaks
Lisa Rooney, 805-447-6437 (media)
Arvind Sood, 805-447-1060 (investors)

(Logo: http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO)

SOURCE Amgen

media, Lisa Rooney, +1-805-447-6437, or investors, Arvind Sood,
+1-805-447-1060, both of Amgen, Thousand Oaks