Prolia(R) (Denosumab) Granted Marketing Authorization in the European Union

Thousand Oaks, California, May 28, 2010 (ots/PRNewswire) - Amgen Inc.
today announced that the European Commission (EC) has granted
marketing authorization for Prolia(R) (denosumab) for the treatment
of osteoporosis in postmenopausal women at increased risk of
fractures, and for the treatment of bone loss associated with hormone
ablation in men with prostate cancer at increased risk of fractures.
Prolia has been approved in all 27 European Union member states plus
Norway, Iceland and Liechtenstein. The European approval of Prolia
marks the first approval of the product worldwide.

"The European approval of Prolia is a significant medical advance
for patients with bone loss conditions," said Will Dere, senior vice
president and international chief medical officer at Amgen. "In
particular, we believe that Prolia will offer patients with
postmenopausal osteoporosis at increased risk for fracture an
important alternative to current treatments. Prolia reduces the risk
of fracture through a convenient injection given every six months.
Amgen is proud to make this new treatment available to physicians and
their patients."

The marketing authorization for Prolia comprises data from six
Phase 3 trials, including two pivotal Phase 3 studies with fracture
endpoints in the osteoporosis and prostate cancer settings, which
demonstrated that Prolia administered as a 60mg subcutaneous
injection every six months reduces the incidence of fractures. All
six studies showed Prolia's ability to increase bone mineral density
(a measure of bone strength) at all skeletal sites measured.

"Osteoporosis is a serious, chronic disease that can
significantly impact the lives of millions of affected women. Despite
widely available treatments, new options are still needed to help
protect against fractures," said Professor Socrates E. Papapoulos,
professor of medicine, consultant physician and director of bone and
mineral research at the department of endocrinology & metabolic
diseases of the Leiden University Medical Center, The Netherlands.
"By targeting RANK Ligand, Prolia offers an innovative new approach
that helps reduce fracture risk."

"The approval of Prolia in the European Union is great news for
patients as it is the first and only product approved in Europe for
the treatment of bone loss associated with hormone ablation in men
with prostate cancer at increased risk of fractures," said Professor
Bertrand Tombal, chairman of the division of urology and associate
professor of physiology at the Universite catholique de Louvain
(UCL), Cliniques universitaires Saint-Luc, Brussels, Belgium. "Bone
loss can be a serious problem for men undergoing hormone ablation
therapy for prostate cancer and if left untreated it can lead to
fractures."

Efficacy

Results from the pivotal three-year Phase 3 Fracture REduction
Evaluation of Denosumab in Osteoporosis every six Months (FREEDOM)
study in 7,808 women with postmenopausal osteoporosis showed that
women receiving a subcutaneous injection of Prolia every six months
experienced a 68 percent reduction in the relative risk of suffering
a new vertebral (spine) fracture compared to those receiving placebo
as well as a 40 percent reduction in the relative risk of suffering a
hip fracture and a 20 percent reduction in the relative risk of
suffering a nonvertebral fracture at 36 months.(i)

Results from the pivotal HALT (Hormone Ablation Bone Loss Trial)
study which evaluated change from baseline in lumbar spine BMD in
1,468 men undergoing androgen deprivation therapy (ADT) for
non-metastatic prostate cancer showed that patients treated with
Prolia experienced a 62 percent reduction in the relative risk of
suffering a new vertebral fracture with Prolia compared to placebo at
36 months, with significant reduction observed as early as month
12.(ii)

Safety and Administration

The most common adverse reactions with Prolia were urinary tract
infection, upper respiratory tract infection, sciatica, cataracts,
constipation, rash, pain in extremity. The most serious adverse
reactions were those of skin infections, predominantly cellulitis,
reported more commonly in the Prolia group compared with placebo (0.4
percent vs. 0.1 percent) in postmenopausal osteoporosis studies. In
breast and prostate cancer studies, serious adverse reactions of skin
infection were similar in the Prolia and placebo groups (0.6 percent
vs. 0.6 percent). In the Phase 3 placebo-controlled clinical trial in
patients with prostate cancer receiving ADT an imbalance in cataract
adverse events was observed with Prolia compared with placebo (4.7
percent vs 1.2 percent placebo). No imbalance in cataract adverse
events was observed in postmenopausal women with osteoporosis or in
women undergoing aromatase inhibitor therapy for nonmetastatic breast
cancer.

The recommended dose of Prolia is 60mg administered as a single
subcutaneous injection every six months.

About Prolia

Prolia (denosumab) has a unique mechanism of action. It is the
first and only approved therapy that specifically targets RANK
Ligand, an essential regulator of osteoclasts (the cells that break
down bone).

Prolia is under regulatory review in the United States (U.S.),
Switzerland, Australia and Canada.

About Osteoporosis

Often referred to as the "silent epidemic," osteoporosis is a
global problem that is increasing in significance as the population
of the world both increases and ages. The World Health Organization
(WHO) has recently identified osteoporosis as a priority health issue
along with other major non-communicable diseases.

An estimated 30 percent of all post-menopausal women in Europe
have osteoporosis, and more than 40 percent of them will suffer
osteoporotic fractures in their lifetime.(iii) Osteoporotic fractures
can impose a significant financial burden to individuals and health
services.(iv) The total direct medical cost of osteoporosis in Europe
has been estimated at more than euro 36 billion annually, and is
expected to increase to euro 76.7 billion in 2050 as the population
ages.(v)

Along with proper diet and weight-bearing exercise, medications
can help slow bone loss and reduce the risk of fracture.

About Cancer Treatment-Induced Bone Loss due to Hormone Ablation

Prostate cancer is the most common form of cancer in men in
Europe and accounts for over 24 percent of cancer diagnoses.(vi)
Prostate cancer patients undergoing ADT experience accelerated bone
loss and an increased fracture risk. It is common for prostate cancer
patients to receive hormone ablation therapies that can lead to a
decrease in bone mass and increased risk of fractures. One in five
men treated with hormone ADT for prostate cancer will experience a
fracture within five years.(vii)

No other EMA-approved therapies currently exist for the
management of bone loss due to hormone ablation therapy in patients
with prostate cancer.

About Denosumab Collaborations

In July 2009, Amgen and GlaxoSmithKline (GSK) announced a
collaboration agreement to jointly commercialize Prolia for
postmenopausal osteoporosis in Europe, Australia, New Zealand and
Mexico once the product is approved in these countries. Amgen will
commercialize Prolia's postmenopausal osteoporosis and oncology
indications in the U.S. and Canada and for all oncology indications
in Europe and in other specified markets.

In addition, GSK will register and commercialize denosumab for
all indications in countries where Amgen does not currently have a
commercial presence, including China, Brazil, India and South Korea
but excluding Japan. The structure of the collaboration allows Amgen
the option of an expanded role in commercialization in both Europe
and certain emerging markets in the future.

Amgen and Daiichi-Sankyo Company, Limited have a collaboration
and license agreement for the development and commercialization of
denosumab in Japan.

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, visit
http://www.amgen.com.

About GlaxoSmithKline

GlaxoSmithKline - one of the world's leading research-based
pharmaceutical and healthcare companies - is committed to improving
the quality of human life by enabling people to do more, feel better,
and live longer. For company information, visit GlaxoSmithKline at
www.gsk.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
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estimates of revenues, operating margins, capital expenditures, cash,
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and more fully described in the Securities and Exchange Commission
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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
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information as of May 28, 2010 and expressly disclaims any duty to
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No forward-looking statement can be guaranteed and actual results
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information discussed in this news release.

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 60mg dose. The
Prolia(TM) trade name is only for these indications and may not apply
for other indications of denosumab.

To view the Prolia (denosumab) Summary of Medicinal Product
Characteristics, click here: http://www.amgen.com.

CONTACT:
Amgen, Zug, Switzerland
Wendy Woods-Williams: +41-(41)-3692-542 (media, osteoporosis)
Sabeena Ahmad: +41-(41)-3692-530 (media, oncology)
Amgen, Thousand Oaks, California
Sarah Reines: +1-805-447-9783 (media, osteoporosis)
Christine Regan: +1-805-447-5476 (media, oncology)
Arvind Sood: +1-805-447-1060 (investors)
i Cummings SR, et al. Twice Yearly Denosumab, a Monoclonal Antibody
to RANK-ligand, for Prevention of Fractures in Postmenopausal Women
with Osteoporosis. N Engl J Med, 2009 Aug. 20; published online at
www.nejm.org on Aug. 11, 2009.'
ii Smith MR, et al. Denosumab for the Prevention of Bone Loss and
Fractures in Men Receiving Androgen Deprivation Therapy in Non-
Metastatic Prostate Cancer. N Engl J Med, 2009 Aug. 20; published
online at www.nejm.org on Aug. 11, 2009.
iii Epidemiology." International Osteoporosis Foundation. Accessed
at http://www.iofbonehealth.org/health-professionals/about-
osteoporosis/epidemiology.html on 10 March 2009.
iv Cooper C. The crippling consequences of fractures and their
impact on quality of life. Am J Med. 1997;103(2A):12S-17S.
v "Facts and statistics about osteoporosis and its impact."
International Osteoporosis Foundation. Accessed at http://
www.iofbonehealth.org/facts-and-statistics.html on 10 March 2009.
vi Ferlay J, et al. Estimates of the cancer incidence and mortality
in Europe in 2006. Annals of Oncology, 2007 Feb. 7.
vii Shahinian VB, Kuo YF, Freeman JL, Goodwin JS. Risk of fracture
after androgen deprivation for prostate cancer. N Engl J Med.
2005;352(2):154-64.

ots Originaltext: Amgen
Im Internet recherchierbar: http://www.presseportal.de

Contact:
CONTACT: Amgen, Zug, Switzerland, Wendy Woods-Williams:
+41-(41)-3692-542(media, osteoporosis), Sabeena Ahmad:
+41-(41)-3692-530 (media, oncology),or Amgen, Thousand Oaks,
California, Sarah Reines, +1-805-447-9783 (media,osteoporosis),
Christine Regan, +1-805-447-5476 (media, oncology), ArvindSood,
+1-805-447-1060 (investors)