Prolia(R) (denosumab) Open-Label Extension Trial Showed Continued Increase in Bone Mineral Density Over Five Years of Treatment With Similar Safety Profile Observed in Pivotal Trial

Thousand Oaks, California (ots/PRNewswire) - Amgen
today announced new long-term data showing that during the fourth and
fifth years of Prolia(R) (denosumab) treatment, postmenopausal women
with osteoporosis receiving Prolia continued with further,
statistically significant, year-over-year increases in lumbar spine
and total hip bone mineral density (BMD), a key measurement of bone
strength. The overall adverse event profile was similar for the
fourth and fifth years of consecutive Prolia treatment.

The data, which were presented at the annual European Congress
Osteoporosis and Osteoarthritis (ECCEO11-IOF) in Valencia, Spain,
showed that treatment with Prolia, the first and only approved RANK
Ligand inhibitor for the treatment of postmenopausal osteoporosis,
resulted in robust BMD gains after five continuous years of treatment
(13.7 percent for lumbar spine BMD and 7.0 percent for total hip
BMD).

The FREEDOM Study and the 5-Year Prolia Data

The pivotal FREEDOM (Fracture REduction Evaluation of Denosumab
in Osteoporosis every 6 Months) study established the efficacy and
safety of Prolia based on three years of data from approximately
7,800 postmenopausal women. The open-label extension of FREEDOM is
evaluating the long-term (up to 10 years) efficacy and safety of
Prolia in 4,550 postmenopausal women. Seventy percent of eligible
women from the FREEDOM study continued enrollment in the extension
study; 2,343 women continued to receive Prolia treatment, and 2,207
transitioned from placebo to Prolia.

Continued treatment with Prolia resulted in consistent
year-over-year gains in BMD at the lumbar spine and total hip. In
years 4 and 5 respectively, women taking Prolia experienced further
1.9 percent and 1.7 percent increases in lumbar spine BMD and further
0.7 percent and 0.6 percent increases in total hip BMD (all P<0.0001
compared with extension baseline).

The incidences of new osteoporotic fractures also remained low
for women taking Prolia for five years.

The women who transitioned from placebo to Prolia in the
extension study showed significant BMD increases during the first two
years of Prolia treatment: 7.9 percent increase in lumbar spine BMD
and 4.1 percent increase in total hip BMD (all P<0.0001 compared with
extension baseline).

Rates of adverse events (AEs) were 83.4 percent for women who
continued on Prolia and 82.8 percent for women transitioned from
placebo to Prolia. Rates of serious AEs were 18.9 percent and 19.4
percent for the two groups respectively. Two subjects in the group
that transitioned from placebo to Prolia had AEs adjudicated to
osteonecrosis of the jaw (ONJ) that healed without further
complications. One of these subjects continued Prolia, and one
subject discontinued. No atypical femoral fractures were reported in
either group.

Osteoporosis: Impact and Prevalence

Referred to as a "silent epidemic" by the International
Osteoporosis Foundation (IOF), osteoporosis is a global problem that
is increasing in significance as the population of the world both
increases and ages. The World Health Organization has officially
declared osteoporosis a public health crisis, and the IOF is urging
governments worldwide to make osteoporosis a healthcare priority.

Osteoporosis-associated fractures are a significant cause of
mortality and morbidity. In 2000, the number of osteoporotic
fractures in Europe was estimated at 3.79 million, of which 890,000
were hip fractures.(1) Since 2001, the incidence of hip fractures in
European countries has risen significantly.(2) In the United States
(U.S.), the number of fractures due to osteoporosis is expected to
rise to more than three million by 2025.(3)

The direct medical cost of osteoporotic fractures in Europe is
expected to rise from euro 31.7 billion in 2000 to euro 76.7 billion
in 2050.(4) In 2005, osteoporosis-related fractures were responsible
for an estimated $19 billion in cost in the U.S., and this cost is
expected to rise to approximately $25 billion by 2025.(5)

About Prolia

Prolia is the first approved therapy that specifically targets
RANK Ligand, an essential regulator of osteoclasts (the cells that
break down bone).

Prolia is approved in the European Union (EU) 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 is approved in the U.S. for the treatment of
postmenopausal women with osteoporosis at high risk for fracture,
defined as a history of osteoporotic fracture, or multiple risk
factors for fracture; or patients who have failed or are intolerant
to other available osteoporosis therapy.

Prolia is available in 12 European countries, the U.S., Canada
and Australia. Applications in the rest of the world are pending.

Prolia is administered as a single subcutaneous injection of 60mg
once every six months. For further information on Prolia, please
visit: http://www.prolia.com.

Important EU Safety Information

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). No imbalance in cataract adverse events was
observed in postmenopausal women with osteoporosis or in women
undergoing aromatase inhibitor therapy for nonmetastatic breast
cancer.

Prolia may lead to hypocalcaemia. Hypocalcaemia must be corrected
by adequate intake of calcium and vitamin D before initiating
therapy. ONJ has been reported rarely in clinical studies in patients
receiving denosumab at a dose of 60 mg every 6 months for
osteoporosis.

Important U.S. Safety Information

Prolia is contraindicated in patients with hypocalcemia.
Pre-existing hypocalcemia must be corrected prior to initiating
Prolia. Hypocalcemia may worsen, especially in patients with severe
renal impairment. All patients should be adequately supplemented with
calcium and vitamin D.

In the pivotal study, serious infections leading to
hospitalizations were reported more frequently in the Prolia-treated
patient group. Serious skin infections, as well as infections of the
abdomen, urinary tract and ear, were more frequent in patients
treated with Prolia. Patients should be advised to seek prompt
medical attention if they develop signs or symptoms of severe
infection, including cellulitis. Endocarditis was reported more
frequently in the Prolia-treated patient group. Epidermal and dermal
adverse events such as dermatitis, rashes, and eczema have been
reported. Discontinuation of Prolia should be considered if severe
symptoms develop.

Prolia resulted in significant suppression of bone remodeling.
The significance of these findings is unknown. The long-term
consequences of the degree of suppression of bone remodeling observed
with Prolia may contribute to adverse outcomes such as ONJ, atypical
fractures, and delayed fracture healing. ONJ has been reported in
patients with Prolia. Patients should be monitored for these adverse
outcomes. The most common adverse reactions (> 5 percent and more
common than placebo) were back pain, pain in extremity,
musculoskeletal pain, hypercholesterolemia, and cystitis.
Pancreatitis has also been reported with Prolia.

Denosumab Commercialization Collaborations

In July 2009, Amgen and GlaxoSmithKline 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 potential oncology
indications in the U.S. and Canada and for all oncology indications
in Europe and in other specified markets.

In addition, GlaxoSmithKline 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, 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 vital medicines, visit http://www.amgen.com.

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Editor's Note: Prolia(R) (denosumab) currently is not
commercialized in Spain.

CONTACT: Amgen, Thousand Oaks
Ashleigh Koss: +1-805-313-6151 (U.S. media)
Wendy Woods Williams: +41(41)3692-542 (E.U. media)
Arvind Sood: +1-805-447-1060 (investors)

(1) "Facts and statistics about osteoporosis and its impact."
International Osteoporosis Foundation. Accessed at http://www.iofbone
health.org/facts-and-statistics.html#factsheet-category-22 on 4
February 2011

(2) "Osteoporosis in the European Union in 2008: Ten years of
progress and ongoing challenges." Accessed at http://www.iofbonehealt
h.org/publications/eu-policy-report-of-2008.html on 4 February 2011

(3) Burge R, et al. Incidence and economic burden of
osteoporosis-related fractures in the United States, 2005-2025. J
Bone Miner Res. 2007: 22::465-475

(4) "Facts and statistics about osteoporosis and its impact."
International Osteoporosis Foundation. Accessed at
http://www.iofbonehealth.org/facts-and-statistics.html on 4 February
2011

(5) "Fast Facts" National Osteoporosis Foundation. Accessed at
http://www.nof.org/node/40 on 4 February 2011

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Contact:
U.S. media - Ashleigh Koss, +1-805-313-6151; E.U. media - WendyWoods
Williams: +41(41)3692-542; investors, Arvind Sood: +1-805-447-1060