Thousand Oaks, California (ots/PRNewswire) - Amgen Inc.
today announced that the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA) has announced a
positive opinion for the marketing authorization of Prolia(TM)
(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. If approved by the European Commission,
Amgen would receive marketing authorization for Prolia in all
European Union (EU) Member States.

"Nearly two decades ago, Amgen researchers described a
fundamental biochemical pathway that controls bone remodeling," said
Roger M. Perlmutter, executive vice president of Research and
Development at Amgen. "Armed with this information, our scientists
identified a targeted therapy that acts via this normal control
mechanism to reduce bone loss. Today's announcement by the CHMP
offers the hope that this important new therapy will soon be
available to European women with post menopausal osteoporosis, and to
European men with prostate cancer who, as a result of hormone
ablation therapy, have a significantly increased risk of fracture.
With its ability to significantly reduce fractures at key skeletal
sites throughout the body, a favorable benefit-risk profile, and
convenient dosing every six months, Prolia addresses an important
unmet medical need."

The CHMP positive opinion is based on data from six Phase 3
trials. Two Phase 3 pivotal studies with fracture endpoints in the
osteoporosis and prostate cancer settings demonstrated that Prolia
administered as a subcutaneous injection twice yearly (60mg) reduces
the incidence of fractures. All six studies showed Prolia's ability
to increase bone mineral density at all skeletal sites measured.

Results from the pivotal FREEDOM (Fracture REduction Evaluation
of Denosumab in Osteoporosis every six Months) study in 7,868 women
with postmenopausal osteoporosis showed that women receiving a
subcutaneous injection of Prolia twice-yearly experienced a 68
percent reduction in the risk of suffering a new vertebral (spine)
fracture compared to those receiving placebo, as well as a 40 percent
reduction in the risk of suffering a hip fracture and a 20 percent
reduction in the risk of suffering a nonvertebral fracture.(i)
Results from the pivotal Hormone AbLation Therapy study 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 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) In both
pivotal studies, the incidence and types of adverse reactions
observed with Prolia were similar to those seen in patients taking a
placebo. The most common adverse reactions in both the Prolia and
placebo groups were arthralgia, back pain, hypertension,
nasopharyngitis, constipation and pain in an extremity. Serious
adverse reactions of skin infections, predominantly cellulitis, were
reported more commonly in the Prolia group (0.4 percent vs. <0.1
percent) in postmenopausal osteoporosis studies. In breast and
prostate cancer studies, serious adverse reactions were similar in
the Prolia and placebo groups (0.6 percent vs. 0.6 percent).

Prolia is also under regulatory review in the United States
(U.S.), Switzerland, Australia and Canada for the treatment and
prevention of postmenopausal osteoporosis and for the treatment of
bone loss in patients undergoing hormone ablation therapy for breast
or prostate cancer.

About Denosumab

Denosumab has a unique mechanism of action. It is the first and
only therapy in late stage development that specifically targets RANK
Ligand, an essential regulator of osteoclasts (the cells that break
down bone). Administered every six months as a subcutaneous injection
just under the skin, denosumab helps stop the process that causes
bone loss, resulting in greater bone density, stronger bones and
reduced risk for fractures at the spine, hip and other non-vertebral
sites.

Given its potential to inhibit all stages of osteoclast
development through a unique and targeted mechanism, denosumab is
also being studied in a range of other bone loss conditions including
rheumatoid arthritis, and for its potential to delay bone metastases
and inhibit and treat bone destruction in patients with advanced
cancer.

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. It is estimated that 30 percent
of postmenopausal women in the EU have osteoporosis.(iii) The World
Health Organization (WHO) has recently identified osteoporosis as a
priority health issue along with other major non-communicable
diseases.

Osteoporotic fractures 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. Yet despite
the availability of osteoporosis treatments for more than 10 years,
the worldwide lifetime risk of fracture remains high at 30-50 percent
for women and 15-30 percent for men(vi).It is estimated that fewer
than 50 percent of patients adhere to their current therapy for more
than one year(vii,viii,ix), which may leave many patients
insufficiently protected against bone loss.

About 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.(x) 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.

No 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 the drug for postmenopausal osteoporosis and oncology
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 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
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Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for
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discussed in this news release.

CONTACT:
Amgen, Zug, Switzerland
Marie Fay: +41-(41)-3690-339 (media, osteoporosis)
Sabeena Ahmad: +41-(41)-3692-530 (media, oncology)
Amgen, Thousand Oaks
Kerry Beth Daly: +1-(805)-447-3020 (media, osteoporosis)
Christine Regan: +1-(805)-447-5476 (media, oncology)
John Shutter: +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-o
steoporosis/epidemio logy.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) International Osteoporosis Foundation (2002). Osteoporosis
in the Workplace: The social, economic and human costs of
osteoporosis on employees, employers and governments

(vii) Rossini M et al. Osteoporosis Int. 2006;17:914-921

(viii) Payer J et al. Biomed Pharmacother 2007;61:191-193

(ix) McCombs JS et al. Maturitas 2004;48:271-287

(x) Ferlay J, et al. Estimates of the cancer incidence and
mortality in Europe in 2006. Annals of Oncology, 2007 Feb. 7.

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

Contact:
CONTACT: Switzerland, media, osteoporosis, Marie Fay,
+41-(41)-3690-339,or media, oncology, Sabeena Ahmad,
+41-(41)-3692-530, both of Amgen, Zug,Switzerland, or media,
osteoporosis, Kerry Beth Daly, +1-805-447-3020, ormedia, oncology,
Christine Regan, +1-805-447-5476, or investors, JohnShutter,
+1-805-447-1060, all of Amgen, Thousand Oaks