THOUSAND OAKS, Calif., Sept. 10 /PRNewswire-FirstCall/ -- Amgen
(NASDAQ: AMGN) today announced that new data will be presented on
the burden of osteoporosis, current osteoporosis treatment
challenges and Prolia(TM) (denosumab) at the 2009 American Society
for Bone and Mineral Research (ASBMR) annual meeting in Denver from
Sept. 11-15, 2009. Prolia currently is being evaluated by
regulatory bodies in the United States (U.S.), the European Union,
Switzerland, Australia and Canada as a potential therapy for
postmenopausal osteoporosis and bone loss in patients undergoing
hormone ablation for prostate and breast cancer. "The continued
need for new alternatives to treat postmenopausal osteoporosis is
reinforced by data that will be presented at this year's ASBMR
meeting. These data highlight challenges with adherence to therapy
and show the link between adherence and fracture outcomes," said
Roger M. Perlmutter, M.D., Ph.D., executive vice president for
Research and Development at Amgen. "Clinical data that will be
presented at the meeting include a Phase 3 study sub-analysis
showing Prolia's effect on fracture reduction in woman at a greater
risk for fracture, 6-year efficacy and safety data from a Phase 2
study, and bone histology data." ASBMR abstracts are available and
can be viewed online at http://www.asbmr.org/. Identified below are
selected abstracts of interest on Amgen research. Prolia(TM)
(denosumab) -- Effects of Denosumab on Bone Mineral Density and
Biochemical Markers of Bone Turnover: 6 Year Results of a Phase 2
Clinical Trial Lead Author: Miller P Abstract No. 1026 (Saturday,
Sept. 12, 2009, 10:15am MT) -- Effects of Denosumab on Bone
Histomorphometry: the FREEDOM and STAND Studies Lead Author: Reid
IR Abstract No. 1027 (Saturday, Sept. 12, 2009, 10:30am MT) --
Effect of Denosumab on the Incidence of Hip, New Vertebral, and
Nonvertebral Fractures Over 3 Years Among Postmenopausal Women with
Higher Fracture Risk: A Subgroup Analysis From the FREEDOM Study
Lead Author: Boonen S Abstract No. 1199 (Monday, Sept. 14, 2009,
3:00pm MT) -- Effects of Denosumab Treatment and Discontinuation on
Bone Mineral Density and Bone Turnover Markers in Postmenopausal
Women With Low Bone Mass Lead Author: Bone H Abstract No. 1243
(Monday, Sept. 14, 2009, 5:30pm MT) -- Baseline Remodeling
Intensity and Greater Suppression by Denosumab Than Alendronate:
Effects on HR-pQCT Parameters at the Radius Lead Author: Seeman SE
Abstract No. 1244 (Monday, Sept. 14, 2009, 5:45pm MT) -- Evaluation
of Health-Related Quality of Life in Postmenopausal Women Who
Participated in the FREEDOM Trial Lead Author: Siris E Abstract No.
1282 (Tuesday, Sept. 15, 2009, 11:15am MT) -- Increases in BMD on
Denosumab Explains Much of the Reduction in Fracture Risk Lead
Author: Cummings SR Abstract No. 1284 (Tuesday, Sept. 15, 2009,
11:45am MT) Osteoporosis Burden and Treatment Challenges -- Impact
of Treatment Satisfaction (Perceived Benefits, Convenience, Side
Effects) on Persistence with Postmenopausal Osteoporosis (PMO)
Therapy Lead Author: Do T Abstract No. SA0317 (Saturday, Sept. 12,
2009, 11:30 am MT) -- Impact of Adherence to Osteoporosis
Medication on Risk of Fracture Lead Author: Halpern R. Abstract No.
SA0368 (Saturday, Sept. 12, 2009, 11:30 am MT) -- Association
Between Adherence to Osteoporosis Medication and Inpatient Stays
and Medical Services Costs Lead Author: Iqbal SU Abstract No.
SU0387 (Sunday, Sept. 13, 2009, 11:30 am MT) -- Comorbidities, Bone
Loss and Concomitant Medication Use in European Postmenopausal
Women: POSSIBLE EU Lead Author: Freemantle N Abstract No. MO0369
(Monday, Sept. 14, 2009, 12:00pm MT) -- Assessment of Patient
Preference, Satisfaction, and Bother with Two Treatments For
Postmenopausal Bone Loss Lead Author: Gold DT Abstract No. MO0369
(Monday, Sept. 14, 2009, 12:00pm MT) About Prolia(TM) (denosumab)
Prolia is the first fully human monoclonal antibody in late stage
clinical development that specifically targets RANK Ligand, an
essential regulator of osteoclasts (the cells that break down
bone). Prolia is being investigated for its potential to inhibit
all stages of osteoclast activity through a targeted mechanism.
Prolia is being studied in a range of bone loss conditions
including postmenopausal osteoporosis and bone loss in patients
undergoing hormone ablation for prostate and breast cancer. In
February 2009, the U.S. Food and Drug Administration (FDA) accepted
the Biologics License Application (BLA), submitted by Amgen for
Prolia for the treatment and prevention of osteoporosis in
postmenopausal women and cancer treatment-induced bone loss in
women and men receiving hormone therapy for either breast cancer or
prostate cancer based on these studies and a parallel trial in
women with breast cancer. The FDA has provisionally approved the
trade name Prolia in these proposed indications, for which
denosumab is administered twice yearly subcutaneously at a 60mg
dose. The trade name is only for these indications and may not
apply for other indications of denosumab. Amgen has also submitted
marketing applications for use of Prolia in the European Union,
Canada, Switzerland, and Australia. Osteoporosis: Impact and
Prevalence 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. The economic burden of osteoporosis is comparable to that
of other major chronic diseases; for example, in the U.S., the
costs associated with osteoporosis-related fractures are equivalent
to those of cardiovascular disease and asthma.(i,ii,iii) It has
been reported that osteoporosis results in more hospital bed-days
than stroke, myocardial infarction or breast cancer.(iv) 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/. 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 Sept. 9,
2009 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
payors, 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. Food and Drug Administration (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. i. Burge R, et al. J Bone Miner
Res. 2007; 22:465-475 ii. "Osteoporosis Fast Facts." National
Osteoporosis Foundation. Accessed on August 19, 2009 at
http://www.nof.org/osteoporosis/diseasefacts.htm iii. "Economic
Cost of Cardiovascular Diseases." American Heart Association.
Accessed on February 24, 2009 at
http://www.americanheart.org/statistics/10econom.html. iv. Lippuner
K, et al. "Incidence and direct medical costs of hospitalisations
due to osteoporotic fractures in switzerland." Osteoporosis
International.1997;7:414-25. CONTACT: Amgen, Thousand Oaks Sarah
Reines: (805) 447-9783 (U.S. media) Arvind Sood: (805) 447-1060
(investors) (Logo:
http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO)
http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO
http://photoarchive.ap.org/ DATASOURCE: Amgen CONTACT: U.S. Media,
Sarah Reines: +1-805-447-9783, Investors, Arvind Sood,
+1-805-447-1060, both of Amgen, Thousand Oaks Web Site:
http://www.amgen.com/
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