Prolia(TM) (denosumab) Receives Best New Drug Honor at Scrip Awards

Thousand Oaks, California, November 5 (ots/PRNewswire) - Amgen is
pleased to announce that it has won the Best New Drug award for
Prolia(TM) (denosumab), a novel treatment approved in the United
States (U.S.) for women with postmenopausal osteoporosis at high risk
for fracture, at the 2010 Scrip Awards ceremony Nov. 4 in London.
Named one of TIME's Top 10 Medical Breakthroughs of 2009, Prolia is
the first treatment specifically designed to target osteoclasts, the
cells that break down bone.

In addition to its novel mechanism of action, the Scrip judges
highlighted Prolia's efficacy in reducing fractures and dosing
regimen. Prolia, the first and only RANK Ligand inhibitor approved in
the U.S. and the European Union (EU), is an every six month
subcutaneous injection.

"We are honored to be recognized again by our industry peers with
the Best New Drug award," said Roger M. Perlmutter, M.D., Ph.D.,
executive vice president of Research and Development at Amgen. "Only
last year we were recognized by Scrip for our robust pipeline, which
at the time included Prolia. This medicine is the result of more than
a decade of work, beginning with Amgen's discovery of a pathway that
regulates bone metabolism and culminating in this important new
treatment option for patients with bone disease."

Osteoporosis is a serious, chronic disease that affects 30
percent of postmenopausal women in the EU.(i) In the U.S., one in two
women over the age of 50 with postmenopausal osteoporosis will
experience a fracture in her remaining lifetime.(ii) Postmenopausal
women with osteoporosis who have experienced a fracture are at
increased risk for another fracture.(iii),(iv), (v)

The annual Scrip Awards are independently judged by a panel of
senior industry experts and are given to biotechnology and
pharmaceutical companies for their contribution to the improvement of
healthcare. For more information, visit the Scrip website
http://www.scripintelligence.com/awards/

About Prolia

Prolia is approved for use in the U.S., the EU, Canada, Australia
and Switzerland. In the U.S., Prolia is approved 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. In postmenopausal women with
osteoporosis, Prolia reduces the incidence of vertebral,
non-vertebral and hip fractures. The U.S. prescribing information
indicates Prolia should be administered by a healthcare professional.

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 demonstrated that Prolia,
administered as a 60mg subcutaneous injection every six months,
compared with placebo at three years resulted in:(vi)

-- A 68 percent reduction in vertebral fractures (4.8 percent absolute
risk reduction). The incidence of new spine fractures was 2.3 percent
with Prolia vs. 7.2 percent with placebo;
-- A 40 percent reduction in hip fractures (0.3 percent absolute risk
reduction). The incidence of hip fractures was 0.7 percent with Prolia
vs. 1.2 percent with placebo;
-- A 20 percent reduction in non-vertebral fractures (1.5 percent
absolute risk reduction). The incidence of non-spine fractures was 6.5
percent with Prolia vs. 8 percent with placebo;
-- Significant bone density increases at all key sites measured (8.8
percent at the lumbar spine, 6.4 percent at the total hip, and 5.2
percent at the femoral neck).

In the EU, Prolia is approved 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 also the
first and only product approved in the EU for the treatment of bone
loss associated with hormone ablation in men with prostate cancer at
increased risk of fractures.

Important U.S. Prolia 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 osteonecrosis
of the jaw (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.

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 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.

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

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 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 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.

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CONTACT: Amgen, Thousand Oaks
Sarah Reines: +1-805-447-5476 (media)
Arvind Sood: +1-805-447-1060 (investors)

(i) International Osteoporosis Foundation. Epidemiology. Accessed
at http://www.iofbonehealth.org/health-professionals/about-osteoporos
is/epidemiology.html on 28 October 2010.

(ii) National Osteoporosis Foundation. Osteoporosis Fast Facts.
Washington (DC): Accessed at http://www.nof.org/node/40 on 28 October
2010.

(iii) Kanis JA et al. A Meta-Analysis of Previous Fracture and
Subsequent Fracture Risk. Bone. 2004;35(2):375-82.

(iv) Lindsay R et al. Risk of new vertebral fracture in the year
following a fracture. JAMA. 2001 Jan 17;285(3):320-3.

(v) Klotzbuecher CM et al. Patients with prior fractures have an
increased risk of future fractures: a summary of the literature and
statistical synthesis. J Bone Miner Res. 2000 Apr;15(4):721-39.

(vi) Cummings SR et al. Denosumab for Prevention of Fractures in
Postmenopausal Women with Osteoporosis. N Engl J Med. 2009;
361(8):756-65.

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Contact:
CONTACT: media, Sarah Reines, +1-805-447-5476, or investors, Arvind
Sood,+1-805-447-1060, both of Amgen, Thousand Oaks