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

By Amgen, PRNE
Thursday, May 27, 2010

Given as an Injection Every Six Months, Prolia Reduced the Risk of Fractures in Treatment of Postmenopausal Osteoporosis in Women at Increased Risk of Fractures

THOUSAND OAKS, California, May 28, 2010 - Amgen Inc. (Nasdaq: AMGN) 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 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 statements that could be deemed forward-looking
statements, including estimates of revenues, operating margins, capital
expenditures, cash, other financial metrics, expected legal, arbitration,
political, regulatory or 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
May 28, 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 guaranteed and movement from concept to product is uncertain;
consequently, there 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 product. Further, preclinical results do not
guarantee safe and effective performance of product candidates in humans. The
complexity of the human body 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 in the past varied and we
expect similar variability in the future. We develop product candidates
internally and through licensing collaborations, partnerships and joint
ventures. Product candidates that are derived from relationships may be
subject to disputes between the parties or may prove to be not as effective
or as safe as we may have believed at the time of entering into such
relationship. Also, we or others could identify safety, side effects or
manufacturing problems with our products after they are on the market. Our
business may be impacted by government investigations, litigation and
products liability claims. We depend on third parties for a significant
portion of our manufacturing capacity for the supply of certain of our
current and future products and limits on supply may constrain sales of
certain of our current products and product candidate development. In
addition, sales of our products are affected by the reimbursement policies
imposed by third-party payers, including governments, private insurance plans
and managed care providers and may be affected by regulatory, clinical and
guideline developments and domestic and international trends toward managed
care and healthcare cost containment as well as U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government and others' regulations
and reimbursement policies may affect the development, usage and pricing of
our products. In addition, we compete with other companies with respect to
some of our marketed products as well as for the discovery and development of
new products. We believe that some of our newer products, product candidates
or new indications for existing products, may face competition when and as
they are approved and marketed. Our products may compete against products
that have lower prices, established reimbursement, superior performance, are
easier to administer, or that are otherwise competitive with our products. In
addition, while we routinely obtain patents for our products and technology,
the protection offered by our patents and patent applications may be
challenged, invalidated or circumvented by our competitors and there can be
no guarantee of our ability to obtain or maintain patent protection for our
products or product candidates. We cannot guarantee that we will be able to
produce commercially successful products or maintain the commercial success
of our existing products. Our stock price may be affected by actual or
perceived market opportunity, competitive position, and success or failure of
our products or product candidates. Further, the discovery of significant
problems with a product similar to one of our products that implicate an
entire class of products could have a material adverse effect on sales of the
affected products and on our business and results of operations.

The scientific information discussed in this news release related to our
product candidates is preliminary and investigative. Such product candidates
are not approved by the U.S. Food and Drug Administration (FDA), and no
conclusions can or should be drawn regarding the safety or effectiveness of
the product candidates. Only the FDA can determine whether the product
candidates are safe and effective for the use(s) being investigated. Further,
the scientific information discussed in this news release relating to new
indications for our products is preliminary and investigative and is not part
of the labeling approved by the U.S. FDA for the products. The products are
not approved for the investigational use(s) discussed in this news release,
and no conclusions can or should be drawn regarding the safety or
effectiveness of the products for these uses. Only the FDA can determine
whether the products are safe and effective for these uses. Healthcare
professionals should refer to and rely upon the FDA-approved labeling for the
products, and not the 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: 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 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
        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.

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), Arvind Sood, +1-805-447-1060 (investors)

YOUR VIEW POINT
NAME : (REQUIRED)
MAIL : (REQUIRED)
will not be displayed
WEBSITE : (OPTIONAL)
YOUR
COMMENT :