Amgen Receives CHMP Positive Opinion for XGEVA(TM) (Denosumab) in the European Union

Thousand Oaks, California (ots/PRNewswire) - Amgen today
announced that the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) has recommended a
positive opinion for the marketing authorization of XGEVA(TM)
(denosumab) for the prevention of skeletal-related events
(pathological fracture, radiation to bone, spinal cord compression or
surgery to bone) in adults with bone metastases from solid tumors. If
approved by the European Commission, Amgen would receive marketing
authorization for XGEVA in all European Union (EU) Member States. The
CHMP also recommended to grant XGEVA an additional year of data and
market exclusivity in the EU since the indication was considered
significantly new for XGEVA, and based on the significant clinical
benefit of the product in comparison with existing therapies.

Bone metastases, the spread of cancer to the bones, are a common
and serious concern for patients with advanced cancer and present a
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, collectively called
skeletal-related events (SREs). The primary goal of treatment for
bone metastases is to prevent the occurrence of these debilitating
and costly SREs.

"A diagnosis of skeletal-related events associated with bone
metastases is devastating for patients living with cancer, and our
goal is to prevent the occurrence of these debilitating bone
complications, which can disrupt a patient's life and cause
disability, pain, and hospitalization," said Willard Dere, M.D.,
senior vice president and international chief medical officer, Amgen.
"XGEVA provides patients with superior efficacy over Zometa in
preventing skeletal-related events in patients with solid tumors and
prolonging the time until pain worsens. XGEVA also offers the ease of
every four weeks subcutaneous injection and no requirement for dose
adjustment for changes in renal function. XGEVA has the potential to
make a meaningful difference for patients with advanced cancer and
their healthcare providers."

The CHMP positive opinion is based on three pivotal, Phase 3
head-to-head trials that evaluated the effectiveness of XGEVA versus
Zometa(R) (zoledronic acid) at delaying SREs. The clinical program
for XGEVA spanned more than 50 tumor types in over 5,700 patients. In
the SRE 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 metastases due to other solid tumors or
multiple myeloma, XGEVA was non-inferior to Zometa in reducing the
risk of SREs. In an integrated analysis of all three studies XGEVA
was superior to Zometa in delaying time to first on-study SRE by 17
percent or 8.2 months (median time to first skeletal related event of
27.6 months for XGEVA and 19.4 months for Zometa, p <0.0001). In this
analysis, XGEVA was also superior to Zometa in delaying time to
first-and-subsequent on-study SRE by 18 percent (p<0.0001).

In patients with mild or no pain at baseline, time to worsening
pain was delayed for XGEVA compared to Zometa (198 versus 143 days)
(p=0.0002). The time to pain improvement was similar for XGEVA and
Zometa.

In these double-blind trials, XGEVA was administered every four
weeks as a 120 mg subcutaneous injection, versus Zometa delivered
every four weeks via a 15-minute intravenous infusion, with
adjustments for kidney function per the requirements of the Zometa
prescribing information. XGEVA was not associated with renal toxicity
or acute phase reactions, both well known side effects of Zometa
treatment.

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
treatment group. Overall survival and progression-free survival were
similar between arms in all three trials.

XGEVA Regulatory Status

XGEVA is currently approved in the United States (U.S.) for the
prevention of SREs in patients with bone metastases from solid
tumors. XGEVA was approved following a six month priority review by
the U.S. Food and Drug Administration (FDA). In the U.S., XGEVA is
not indicated for the prevention of SREs in patients with multiple
myeloma.(i) XGEVA is also approved in Canada for reducing the risk of
developing SREs in patients with bone metastases from breast cancer,
prostate cancer, non-small cell lung cancer, and other solid tumors.
In Canada, XGEVA is not indicated for reducing the risk of developing
SREs in patients with multiple myeloma.

Amgen has also submitted marketing applications for XGEVA in
Australia, Mexico, Russia and Switzerland. In Japan, Amgen is working
with its licensing partner, Daiichi Sankyo Company, Limited and a
marketing application was submitted in August. In addition, Amgen and
GlaxoSmithKline (GSK) have a collaboration agreement for the
commercialization of XGEVA in a number of countries where Amgen does
not currently have a commercial presence. In these countries,
marketing applications are filed by GSK.

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.

ONJ 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 U.S. prescribing information.

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 90
percent of patients with metastatic disease. (ii) (iii) (iv) (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 the prevention of SREs, XGEVA is also being
evaluated 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, 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
http://www.amgen.com.

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Contact: Amgen
Sabeena Ahmad: +41-41-3692-530 (EU media)
Christine Regan: +1-805-447-5476 (U.S. media)
Arvind Sood: +1-805-447-1060 (investors)

(i) XGEVA(R) (denosumab) [prescribing information]. Thousand
Oaks, Calif: Amgen; 2010.

(ii) Tannock IF, Wit R, Berry WR, Horti J, Pluzanska A, Chi K, et
al. Docetaxel plus prednisone or mitoxantrone plus prednisone for
advanced prostate cancer. N Engl J Med. 2004;351(15):1502-12.

(iii) Petrylak DP, Tangen CM, Hussain MH, Lara PN, Jones JA,
Taplin ME, et al. Docetaxel and estramustine compared with
mitoxantrone and prednisone for advanced refractory prostate cancer.
N Engl J Med. 2004;351(15):1513-1520.

(iv) Prostate cancer clinical trial end points: ''RECIST''ing a
step backwards. American Association for Cancer Research website.
clincancerres.aacrjournals.org. Accessed on February 16, 2011.

(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
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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
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(xi) Johnell O, Kanis JA. An estimate of the worldwide prevalence
and disability associated with osteoporotic fractures. Osteoporos
In.t 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
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