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

By Amgen, PRNE
Thursday, December 17, 2009

THOUSAND OAKS, California, December 18 - Amgen Inc. (Nasdaq: AMGN) 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 statements that could be deemed forward-looking
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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
Dec. 18, 2009 and expressly disclaims any duty to update information
contained in this news release.

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    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
www.iofbonehealth.org/health-professionals/about-osteoporosis/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
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.

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, or media, oncology, Christine Regan, +1-805-447-5476, or investors, John Shutter, +1-805-447-1060, all of Amgen, Thousand Oaks

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