Amgen Presents Several Sub-Analyses At ASBMR From The Ongoing Open-Label Extension Study Of The Pivotal Phase 3 Prolia Fracture

   Amgen Presents Several Sub-Analyses At ASBMR From The Ongoing Open-Label
         Extension Study Of The Pivotal Phase 3 Prolia Fracture Trial

Prolia Open-Label Extension Trial Showed Continued Increases in Bone Mineral
Density and Low Fracture Incidence Over Six Years

PR Newswire

THOUSAND OAKS, Calif., Oct. 14, 2012

THOUSAND OAKS, Calif., Oct. 14, 2012 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today
announced that it has presented data from several Prolia^® (denosumab)
studies, including data from the open-label extension study of the pivotal
Phase 3 fracture trial, which showed continued increases in bone mineral
density (BMD) and low fracture incidence over six years. These data, and those
from several key studies, were presented at the American Society for Bone and
Mineral Research (ASBMR) 2012 Annual Meeting in Minneapolis from Oct. 12-15,

"The data presented provide additional insight into the long-term clinical
profile of Prolia," said Sean E. Harper, M.D., executive vice president of
Research and Development at Amgen. "Given the increasing burden of
osteoporosis in an aging population, it is important to see that continued
Prolia therapy may provide ongoing benefit."

Abstracts are available on the ASBMR website at and updated data
have been presented at the meeting.

  oRelationship Between Changes in Bone Mineral Density (BMD) and Incidence
    of Fracture with 6 Years of Denosumab Treatment
    Lead Author: PD Miller, M.D., University of Colorado Health Science Center
    and Colorado Center for Bone Research
    (Abstract No. 1099; Oral Presentation; October 14)

       oNearly all women who received six years of denosumab treatment showed
         gains in BMD at the lumbar spine, total hip or femoral neck: 95
         percent demonstrated gains of greater than six percent at any of
         these sites. The risk for new or worsening vertebral fracture and
         nonvertebral fracture decreased with increasing percentage change in
         total hip BMD over six years.

  oLong-term Denosumab Treatment Maintains Low Incidence of Fracture in
    Postmenopausal Women >75 Years with Osteoporosis
    Lead Author: S. Papapoulos, M.D., Leiden University Medical Center
    (Abstract No. FR0391; Plenary Poster; October 12)

       oDespite the increase in age of the patients during the pivotal Phase
         3 fracture study extension, denosumab treatment continued to be
         associated with a low incidence of new vertebral, nonvertebral and
         hip fractures.
       oThe incidence of fractures in patients > 75 years in the study
         extension was similar to what was originally observed in women older
         than 75 years in the original pivotal Phase 3 fracture study.

  oEffects of 5 Years of Denosumab on Bone Histology and Histomorphometry:
    FREEDOM Study Extension
    Lead Author: JP Brown, M.D., Laval University and CHUQ
    (Abstract No. 1134; Oral Presentation; October 14)

       oDenosumab treatment through five years resulted in normal bone
         quality with reduced bone turnover, consistent with its mechanism of

About Osteoporosis
Osteoporosis, which causes more than 2 million bone breaks each year, is a
growing concern among health professionals as more than 40 million people are
either living with, or at risk for developing, the disease. The World Health
Organization has officially declared osteoporosis a public health crisis,
while the International Osteoporosis Foundation urges governments worldwide to
make osteoporosis a healthcare priority.

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

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.^1 [ ]The direct medical cost of
osteoporotic fractures in Europe is expected to rise from €31.7 billion in
2000 to €76.7 billion in 2050.^2

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 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 also indicated as a treatment to increase bone mass in women at high
risk for fracture receiving adjuvant aromatase inhibitor therapy for breast
cancer and in men at high risk for fracture receiving androgen deprivation
therapy for nonmetastatic prostate cancer. In these patients with prostate
cancer, Prolia reduced the incidence of vertebral fractures.

Prolia is indicated for treatment to increase bone mass in men 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 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., Canada, Australia and in all 27 EU member
states as well as in Norway, Iceland and Liechtenstein. Applications in the
rest of the world are pending.

Prolia is administered as a single subcutaneous injection of 60 mg once every
six months. For further information on Prolia, including prescribing
information and medication guide, please visit:

Important U.S. Safety Information
Prolia is contraindicated in patients with hypocalcemia. Pre-existing
hypocalcemia must be corrected prior to initiating Prolia. Prolia is
contraindicated in women who are pregnant and may cause fetal harm. Prolia is
contraindicated in patients with a history of systemic hypersensitivity to any
component of the product. Patients receiving Prolia should not receive XGEVA^®
(denosumab), as both Prolia and XGEVA contain the same active ingredient,

Hypocalcemia may worsen with the use of Prolia, especially in patients with
severe renal impairment. All patients should be adequately supplemented with
calcium and vitamin D. In the pivotal Phase 3 study of women with
postmenopausal osteoporosis (n=7808), 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.

In clinical trials in women with postmenopausal osteoporosis, 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 and atypical femoral fractures have 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) in
patients with postmenopausal osteoporosis were back pain, pain in extremity,
musculoskeletal pain, hypercholesterolemia and cystitis. The most common
adverse reactions in men with osteoporosis were back pain, arthralgia and
nasopharyngitis. Pancreatitis has also been reported with Prolia in patients
with osteoporosis. The most common (per patient incidence >10 percent) adverse
reactions reported with Prolia in patients with bone loss receiving androgen
deprivation therapy for prostate cancer or adjuvant aromatase inhibitor
therapy for breast cancer are arthralgia and back pain. Pain in extremity and
musculoskeletal pain have also been reported in clinical trials.

The extent to which Prolia is present in seminal fluid is unknown. For men
treated with Prolia, there is a potential for fetal exposure if the sexual
partner is pregnant. While the risk is likely to be low, patients should be
advised of this potential risk.

Important EU Safety Information
The most common adverse reactions with Prolia were urinary tract infection,
upper respiratory tract infection, sciatica, cataracts, constipation, rash and
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 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. In the post-marketing setting, rare
events of drug-related hypersensitivity have been reported in patients
receiving 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, 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 Follow us on

Forward Looking Statements
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CONTACT: Amgen, Thousand Oaks
Christine Regan, 805-447-5476 (media)
Arvind Sood, 805-447-1060 (investors)


^1National Osteoporosis Foundation. "Fast Facts." Available at: Last accessed on 9 October 2012.
^2International Osteoporosis Foundation." Facts and Statistics." Available at: Last accessed on 9
October 2012.
^3International Osteoporosis Foundation. "Osteoporosis in the European Union
in 2008: Ten years of progress and ongoing challenges." Available
 Last accessed on 9 October 2012.


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