THOUSAND OAKS, Calif. and
BRUSSELS, Oct. 12, 2015 /PRNewswire/ -- Amgen (NASDAQ:
AMGN) and UCB (Euronext Brussels: UCB) today presented additional
findings from an exploratory sub-study of the previously reported
romosozumab Phase 2 trial.1 The findings were presented
today in an oral plenary session at the American Society for Bone
and Mineral Research (ASBMR) 2015 Annual Meeting in Seattle.
The small exploratory sub-study data showed that, at month 12,
the investigational bone-forming agent romosozumab increased
estimated bone strength (percent change from baseline) at the spine
and hip more than open-label teriparatide in postmenopausal women
with low bone mass. These results were measured by a validated
method called finite element analysis (FEA), which utilized
quantitative computed tomography (QCT) scans to simulate
compression overload to estimate vertebral strength, and a sideways
fall to estimate femoral strength.2
"Engineers and physicists have long used finite element analysis
to better understand the structural integrity and failure of
physical objects when subjected to load," said lead investigator
Tony M. Keaveny, Ph.D., professor of
Mechanical Engineering and Bioengineering at the University of California, Berkeley. "By applying
this analysis to bone scans of postmenopausal women with low bone
mass, we were able to integrate the information we had on bone
mineral density and structure to estimate bone strength in those
treated with romosozumab."
The FEA showed that, at the spine, women in the romosozumab
group (210 mg once monthly, n=24) increased estimated strength
compared to baseline by 27.3 percent at month 12, which was greater
than placebo (–3.9 percent, n=27) and teriparatide (18.5 percent,
n=28).2 At the hip, the estimated strength increased
from baseline by 3.6 percent with romosozumab (n=9), compared with
placebo (-0.1 percent, n=18) or teriparatide (-0.7 percent,
n=19).2
These data are from a small exploratory sub-study (n=79) of a
Phase 2 trial (NCT00896532) that included a total of 419 patients.
A subset of these women underwent spine and hip QCT imaging to
measure bone mineral density (BMD) gains.3 To
investigate the effects of romosozumab on bone strength an FEA was
performed on these QCT scans.
"The strength improvements observed with romosozumab in this
trial – and documented using a validated method for assessing
fracture risk and monitoring treatment – further support its
potential as a treatment option for patients at high risk for
fracture," said Sean E. Harper,
M.D., executive vice president of Research and Development at
Amgen. "These important new data support our extensive global Phase
3 program of romosozumab, and we look forward to advancing this
research to help provide a potential new treatment option for
appropriate patients."
Adverse events in the original Phase 2 study were similar across
groups, except for mild, generally non-recurring injection site
reactions observed more frequently with romosozumab compared to
placebo, but with no observed dose-related relationship. The most
common adverse events included mild upper respiratory tract
infection, pain in the back and joints, and headache. These
reactions did not lead to study drug discontinuation or study
withdrawal; the safety of romosozumab will be further addressed in
subsequent larger studies.
"These data illustrate the potential impact of building bone
through both increasing bone formation and decreasing bone
resorption as romosozumab has demonstrated in skeletal regions of
interest. These sub-study results reinforce our confidence in the
ability of romosozumab to build bone strength as well as density
and we look forward to reporting the outcomes of the first fracture
study in 2016," said Professor Dr. Iris
Loew-Friedrich, chief medical officer and executive vice
president at UCB.
About Finite Element Analysis
Finite element analysis (FEA) is a computer model of a material
or design that is stressed and analyzed and tested for specific
results. This involves breaking down an object into a large number
of finite elements (e.g., small cubes), and using mathematical
equations to help predict the behavior of each element. These
behaviors are then calculated by a computer to predict the behavior
of the object as a whole.
FEA has been applied for the past 40 years to simulate the
mechanical behavior of bone, helping to predict strength at major
fracture sites, like the lumbar spine and femoral hip.
About Romosozumab
Romosozumab is an investigational bone-forming monoclonal
antibody and is not approved by any regulatory authority for the
treatment of osteoporosis. It is designed to work by inhibiting the
protein sclerostin, thereby increasing bone formation and
decreasing bone breakdown. Romosozumab is being studied for its
potential to reduce the risk of fractures in an extensive global
Phase 3 program. This program evaluating the safety and efficacy of
romosozumab includes two large fracture trials comparing
romosozumab to either placebo or active comparator in more than
10,000 postmenopausal patients with osteoporosis. Primary results
from the Phase 3 study FRAME are expected in the first half of
2016. Romosozumab is being co-developed by Amgen and UCB.
About Amgen
Amgen is committed to unlocking the potential of biology for
patients suffering from serious illnesses by discovering,
developing, manufacturing and delivering innovative human
therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its biologics manufacturing expertise to strive for solutions that
improve health outcomes and dramatically improve people's lives. A
biotechnology pioneer since 1980, Amgen has grown to be one of the
world's largest independent biotechnology companies, has reached
millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
About UCB
UCB, Brussels, Belgium
(www.ucb.com) is a global biopharmaceutical company focused on the
discovery and development of innovative medicines and solutions to
transform the lives of people living with severe diseases of the
immune system or of the central nervous system. With more than 8500
people in approximately 40 countries, the company generated revenue
of € 3.3 billion in 2014. UCB is listed on Euronext Brussels
(symbol: UCB). Follow us on Twitter: @UCB_news.
Forward-Looking Statements - Amgen
This news release contains forward-looking statements that are
based on the current expectations and beliefs of Amgen Inc. and its
subsidiaries (Amgen or us) 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
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expressly disclaims any duty to update information contained in
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No forward-looking statement can be guaranteed and actual
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identification of new product candidates or development of new
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In addition, sales of our products (including products of our
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Forward-Looking Statements – UCB
This press release contains forward-looking statements based on
current plans, estimates and beliefs of management. All statements,
other than statements of historical fact, are statements that could
be deemed forward-looking statements, including estimates of
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between the partners. Also, UCB or others could discover safety,
side effects or manufacturing problems with its products after they
are marketed.
Moreover, sales may be impacted by international and domestic
trends toward managed care and health care cost containment and the
reimbursement policies imposed by third-party payers as well as
legislation affecting biopharmaceutical pricing and
reimbursement.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(investors)
CONTACT: UCB, Brussels
France Nivelle, Global
Communications, UCB
T +32.2.559.9178, france.nivelle@ucb.com
Laurent Schots, Media Relations,
UCB
T+32.2.559.92.64, Laurent.schots@ucb.com
Antje Witte, Investor Relations,
UCB
T +32.2.559.94.14, antje.witte@ucb.com
References
1 McClung MR, Grauer A, Boonen S, et al. Romosozumab
in postmenopausal women with low bone mineral density. N Engl J
Med. 2014 Jan 30;370(5):412-20.
2 Keaveny TM et al. Romosozumab improves strength at
the lumbar spine and hip in postmenopausal women with low bone mass
compared with teriparatide. Abstract 1143, Oral Presentation,
ASBMR, October 2015.
3 Genant KH et al. Effect of Romosozumab on Lumbar
Spine and Hip Volumetric Bone Mineral Density (vBMD) as Assessed by
Quantitative Computed Tomography (QCT). Presentation Number: 1022,
ASBMR October 2013.
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SOURCE Amgen