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19:41:00 AMGN FDA Approves Amgen's XGEVA(TM) (Denosumab) for the Prevention of Skeletal-Related Events in Patients with Bone Metastases from Solid Tumors


FDA Approves Amgen's XGEVA(TM) (Denosumab) for the Prevention of Skeletal-Related
Events in Patients with Bone Metastases from Solid Tumors

--First Bone Targeted Therapy for Cancer Patients to Be Approved in Nearly a
Decade --Approval Based on Largest Clinical Program Ever Conducted in Patients
with Bone Metastases

THOUSAND OAKS, Calif., Nov. 18, 2010 /PRNewswire via COMTEX/ -- Amgen Inc. (AMGN)
today announced that the U.S. Food and Drug Administration (FDA) has approved
XGEVA(TM) (denosumab), the first and only RANK Ligand inhibitorfor the prevention
of skeletal-related events (SREs) in patients with bone metastases from solid
tumors. XGEVA was approved following a 6 month priority review by the FDA, a
designation reserved for drugs that offer major advances in treatment or provide
a treatment where no adequate therapy exists. XGEVA is not indicated for the
prevention of SREs in patients with multiple myeloma.

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"Today's approval of XGEVA illustrates what is possible when scientific
innovation, commitment and investment come together to advance medicine," said
Kevin Sharer, chairman and chief executive officer of Amgen. "A diagnosis of bone
metastases is a major event for patients living with cancer, and the consequences
can be devastating. We are pleased to offer this new advance to patients and
their healthcare providers."

Bone metastases, the spread of cancer to the bones, are a serious concern for
patients with advanced cancer and present a considerable burden to the healthcare
system. Weakened bones due to metastases can lead to fractures and compression of
the spinal cord and necessitate procedures like major surgery and radiation,
designed to prevent or manage bone complications. The primary goal of treatment
for bone metastases is to prevent the occurrence of debilitating and costly bone
complications, which can disrupt a patient's life and cause disability, pain and
hospitalization.

"As many as 3 out of 4 patients with advanced prostate, lung, and breast cancer
will experience spread to their bones. Despite the availability of current
treatments, a significant proportion of these patients still experience bone
complications or are not candidates for existing treatment," said David H. Henry,
M.D., clinical professor of medicine, and vice chair, Department of Medicine,
Pennsylvania Hospital, University of Pennsylvania Healthcare System. "Based on
the compelling science and robust clinical evidence seen with XGEVA, I expect
this new option to quickly become a mainstay of cancer care and to play an
important role in reducing the incidence of debilitating bone complications in
patients with advanced cancer."

The RANK Ligand pathway, first discovered by Amgen scientists in the mid-1990s,
is believed to play a central role in cancer-induced bone destruction, regardless
of cancer type. XGEVA is a fully human monoclonal antibody that binds to RANK
Ligand, a protein essential for the formation, function and survival of
osteoclasts (the cells that break down bone). XGEVA prevents RANK Ligand
fromactivating its receptor, RANK on the surface of osteoclasts, thereby
decreasing bone destruction.

XGEVA Clinical Trial Experience

The FDA approval of XGEVA is based on the results of three pivotal, Phase 3
head-to-head trials that evaluated XGEVA delivered every four weeks as a 120 mg
subcutaneous injection versus Zometa(R) (zoledronic acid) delivered every four
weeks via a 15-minute intravenous infusion, adjusted for kidney function per the
labeled instructions. The clinical program for XGEVA spanned more than 50 tumor
types in over 5,700 patients. In the Phase 3 trials, XGEVA demonstrated a
clinically meaningful improvement in preventing SREs compared to Zometa.
Specifically, in patients with breast or prostate cancer and bone metastases,
XGEVA was superior to Zometa in reducing the risk of SREs. In patients with bone
metastasis due to other solid tumors or bone lesions due to multiple myeloma,
XGEVA was noninferior (trending towards superiority) to Zometa in reducing the
risk of SREs. Superiority was also seen in the integrated analysis of the Phase 3
studies.

Overall rates of adverse events and serious adverse events were generally similar
between XGEVA and Zometa. Osteonecrosis of the jaw (ONJ) was infrequent, with no
statistically significant difference between treatment arms. Hypocalcemia was
more frequent in the XGEVA arm. Overall survival and progression-free survival
were similar between arms in all three trials.

"As many as 70 percent of patients with prostate cancer that have metastasized to
the bone are not currently receiving therapy to prevent complications from these
bone metastases. This may be secondary to urologists lacking comfort or
facilities to provide infusion treatment," said Neal D. Shore, M.D., FACS,
medical director, Carolina Urologic Research Center. "XGEVA could provide
increased treatment care options and accessibility for urologist's who treat
advanced prostate cancer; as XGEVA is administered as a subcutaneous injection on
a monthly basis. Also, XGEVA does not require dose adjustment for changes in
renal function."

ECONOMIC IMPACT OF SREs

The total economic burden of patients with bone metastases in the U.S. alone
estimated to be $12.6 billion annually.(i) Patients who experience an SRE as a
result of bone metastases incur significantly higher medical costs compared with
those who do not experience such events. (ii, iii, iv) In addition, once patients
experience an SRE, the risk of a subsequent SRE is increased. The costs of SREs
vary by type and severity, ranging from relatively low costs for minor fractures
to high cost events like spinal cord compression associated with hospitalization.
Studies have shown that the costs of treating SREs are a significant cost burden.

XGEVA is an innovative therapy that significantly reduces debilitating and costly
SREs. This can result in cost offsets due to the reduced incidence of SREs and
related medical costs. XGEVA will cost $1,650 monthly based on wholesale
acquisition cost.

XGEVA FIRST STEP(TM) COUPON PROGRAM

Amgen is committed to supporting patient access to important medicines through
innovative programs including our newly established commercial co-pay program for
XGEVA, financial support to independent third party co-pay foundations, and the
Safety Net Foundation, which provides free products to uninsured patients who
qualify. The XGEVA FIRST STEP(TM) Coupon Program is a landmark program among
oncology commercial co-pay programs, as it is the first program under the medical
benefit with no income eligibility requirement. The program is intended to
provide assistance to eligible patients who need help meeting their deductible,
co-insurance, and/or co-payment requirements under the medical benefit for XGEVA.
Under this program, eligible patients will incur no out of pocket costs for their
initial XGEVA injection and pay a maximum of $25 for subsequent injections.

XGEVA Regulatory Status

Amgen has also submitted marketing applications for XGEVA in the European Union,
Australia, Canada and Switzerland. In Japan, Amgen is working with its licensing
partner, Daiichi-Sankyo Company, Limited and a marketing application was
submitted in August.

XGEVA Important Safety Information

XGEVA can cause severe hypocalcemia. Correct pre-existing hypocalcemia prior to
XGEVA treatment. Monitor calcium levels and administer calcium, magnesium, and
vitamin D as necessary. Advise patients to contact a healthcare professional for
symptoms of hypocalcemia.

Osteonecrosis of the jaw can occur in patients receiving XGEVA. Patients who are
suspected of having or who develop ONJ while on XGEVA should receive care by a
dentist or an oral surgeon. In these patients, extensive dental surgery to treat
ONJ may exacerbate the condition.

The most common adverse reactions in patients receiving XGEVA were
fatigue/asthenia, hypophosphatemia, and nausea. The most common serious adverse
reaction in patients receiving XGEVA was dyspnea. The most common adverse
reactions resulting in discontinuation of XGEVA were osteonecrosis and
hypocalcemia. Please visit http://www.amgen.com for full prescribing information.

Denosumab is also marketed as Prolia(TM) in other indications.

Bone Metastases and SREs: Prevalence and Impact

Bone metastases occur in more than 1.5 million patients with cancer worldwide and
are most commonly associated with cancers of the prostate, lung, and breast, with
incidence rates as high as 75 percent of patients with metastatic disease.(v)

Approximately 50-70 percent of cancer patients with bone metastases will
experience debilitating SREs.(vi, vii, viii) Events considered to be SREs include
fractures, spinal cord compression, and severe bone pain that may require surgery
or radiation.(ix) Such events can profoundly disrupt a patient's life and can
cause disability and pain.(x, xi, xii)

Denosumab and Amgen's Research in Bone Biology

The denosumab 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-related bone diseases. Over 11,000 patients have been enrolled in the
denosumab oncology clinical trials. In addition to this newly approved
indication, XGEVA is also being investigated for its potential to delay bone
metastases in prostate and breast cancer.

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, 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,
visithttp://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 expenditures, cash,
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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 Nov.18, 2010 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
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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
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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
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CONTACT: Amgen, Thousand Oaks
Christine Regan: [phone] (media)
Lisa Rooney: [phone] (media)
Arvind Sood: [phone] (investors)

(i) Schulman KL, Kohles J. Economic burden of metastic bone disease in the U.S. American Cancer Society 2007:2334-2342.
(ii) Delea T, Langer C, McKiernan J, et al. The cost of treatment of skeletal-related events in patients with bone metastases from lung cancer. Oncology 2004;67:390-396.
(iii) Schulman KL, Kohles J. Economic burden of metastic bone disease in the U.S. American Cancer Society 2007:2334-2342.
(iv) GVD/2007:2334-2342.Barber ISPOR 2008 Poster
(v) Coleman RE. Skeletal complications of malignancy. Cancer. 1997; 80(suppl): 1588-1594.
(vi) Lipton A, Theriault RL, Hortobagyi GN. Pamidronate prevents skeletal complications and is effective palliative treatment in women with breast carcinoma and osteolytic bone metastases. Cancer 2000;88:1082-1090.
(vii) Saad F, Lipton A, Cook R, Chen YM, Smith M, Coleman R. Pathologic fractures correlated with reduced survival in patients with malignant bone disease. Cancer. 2007;110:1860-1867.
(viii) Rosen LS, Gordon D, Tchekmedyian NS, et al. Nonsmall cell lung carcinoma and other solid tumors. Cancer. 2004;100:2613-2621.
(ix) Costa L, Badia X, Chow E, Lipton A, Wardley A. Impact of skeletal complications on patients' quality of life, mobility, and functional independence. Support Care Cancer. 2008; 16: 879-889.
(x) Norgaard M, Jensen AO, Jacobsen JB, Cetin K, Fryzek JP, Sorensen HT. Skeletal related events, bone metastasis and survival of prostate cancer: a population based cohort study in Denmark (1999 to 2007).J Urol 2010; 184:162-167.
(xi) Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int 2006;17:1726-1733.
(xii) Saad F, Gleason DM, Murray R, et al. A Randomized, Placebo-Controlled Trial of Zoledronic Acid in Patients With Hormone-Refractory MetastaticProstate Carcinoma. Journal Ntl Cancer Inst 2002;19:1458-1468.


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