THOUSAND OAKS, Calif. and
BRUSSELS, Sept. 1, 2015 /PRNewswire/ -- Amgen (NASDAQ:
AMGN) and UCB (Euronext Brussels: UCB) today announced top-line
results from the STRUCTURE trial (STudy evaluating effect of
RomosozUmab Compared with Teriparatide in postmenopaUsal women with
osteoporosis at high risk for fracture pReviously treated with
bisphosphonatE therapy). The study (NCT01796301) met the primary
endpoint, demonstrating a statistically significant difference in
favor of romosozumab in the percent change of total hip bone
mineral density (measured by DXA) through month 12.
STRUCTURE was a Phase 3, multi-center, international,
randomized, open-label, teriparatide-controlled study that
evaluated safety, tolerability and efficacy of romosozumab in women
with postmenopausal osteoporosis. A total of 436 patients
previously treated with bisphosphonate therapy received either
subcutaneous romosozumab (210 mg monthly) or subcutaneous
teriparatide (20 mcg daily) through to month 12.
The overall subject incidence of adverse events was generally
balanced between arms. Adverse events in patients treated with
romosozumab were similar to those previously reported and no new
safety signals were detected. Adverse events reported in the
romosozumab arm in more than five percent of patients were
nasopharyngitis, arthralgia, back pain, headache and fall.
Further analysis of the Phase 3 STRUCTURE study results are
ongoing and will be submitted to a future medical conference and
for publication.
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. First results from the Phase 3 study FRAME are
expected in H1 2016. Romosozumab is being co-developed by Amgen and
UCB.
About Osteoporosis
Osteoporosis affects many women
after menopause as their ability to form new bone cannot counter
balance the rate at which bone is being removed.1,2 This
bone loss leads to weakened bones over time, increasing the
potential for a break.3,4
About half of all women over age 50 will have an
osteoporosis-related fracture in their remaining
lifetime.5 Additionally, patients with a previous hip
fracture have a threefold greater risk of a subsequent fracture
within two years.6,7
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.
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 leading 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.
Amgen Forward-Looking Statements
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 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 Inc., including Amgen
Inc.'s most recent annual report on Form 10-K and any subsequent
periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen
Inc.'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. 1, 2015, 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
and our partners 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 product
liability claims. If we fail to meet the compliance obligations in
the corporate integrity agreement between us and the U.S.
government, we could become subject to significant sanctions. 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 (including products of our
wholly-owned subsidiaries) are affected by the reimbursement
policies imposed by third-party payers, 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 and
our partners routinely obtain patents for products and technology,
the protection of our products offered by patents and patent
applications may be challenged, invalidated or circumvented by our
or our partners' competitors and there can be no guarantee of our
or our partners' 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. Our efforts to integrate the operations of companies we
have acquired may not be successful. We may experience
difficulties, delays or unexpected costs and not achieve
anticipated benefits and savings from our ongoing restructuring
plan. Our business performance could affect or limit the
ability of our Board of Directors to declare a dividend or our
ability to pay a dividend or repurchase common stock.
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, and no conclusions can or
should be drawn regarding the safety or effectiveness of the
product candidates.
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).
UCB is listed on Euronext Brussels (symbol: UCB). Follow us on
Twitter: @UCB_news.
UCB Forward-Looking Statements
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 revenues,
operating margins, capital expenditures, cash, other financial
information, expected legal, political, regulatory or clinical
results and other such estimates and results. By their nature, such
forward-looking statements are not guarantees of future performance
and are subject to risks, uncertainties and assumptions which could
cause actual results to differ materially from those that may be
implied by such forward-looking statements contained in this press
release.
Important factors that could result in such differences include:
changes in general economic, business and competitive conditions,
the inability to obtain necessary regulatory approvals or to obtain
them on acceptable terms, costs associated with research and
development, changes in the prospects for products in the pipeline
or under development by UCB, effects of future judicial decisions
or governmental investigations, product liability claims,
challenges to patent protection for products or product candidates,
changes in laws or regulations, exchange rate fluctuations,
changes or uncertainties in tax laws or the administration of such
laws and hiring and retention of its employees. UCB is
providing this information as of the date of this press release and
expressly disclaims any duty to update any information contained in
this press release, either to confirm the actual results or to
report a change in its expectations.
There is no guarantee that new product candidates in the
pipeline will progress to product approval or that new indications
for existing products will be developed and approved. Products or
potential products which are the subject of partnerships, joint
ventures or licensing collaborations may be subject to differences
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
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
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1 U.S.
Department of Health and Human Services, Office of the Surgeon
General. The 2004 Surgeon General's Report on Bone Health and
Osteoporosis: What It Means to You.
http://www.ncbi.nlm.nih.gov/books/NBK45513/pdf/Bookshelf_NBK45513.pdf.
Published October 14, 2004. Accessed August 5, 2015.
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2 National
Osteoporosis Foundation. Clinician's Guide to Prevention and
Treatment of Osteoporosis.
http://nof.org/files/nof/public/content/file/344/upload/159.pdf.
Published January 2010. Accessed August 5, 2015.
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3
Chavassieux P, et al. Insights into material and structural basis
of bone fragility from diseases associated with fractures: how
determinants of the biomechanical properties of bone are
compromised by disease. Endocr Rev. 2007;28:151-164.
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4 Seeman
E, Delmas PD. Bone quality – the material and structural basis of
bone strength and fragility. N Engl J Med.
2006;354:2250-2261.
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5 American Academy of
Orthopedic Surgeons. Osteoporosis and Bone Health.
http://www.aaos.org/news/aaosnow/may09/clinical8.asp. Accessed
August 5, 2015.
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6
Colón-Emeric C, Kuchibhatla M, Pieper C, et al. The contribution of
hip fracture to risk of subsequent fractures: data from two
longitudinal studies. Osteoporos Int. 2003;14:879-883.
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7 Lyles
KW, Schenck AP, Colón-Emeric CS. Hip and other osteoporotic
fractures increase the risk of subsequent fractures in nursing home
residents. Osteoporos Int. 2008;19:1225-1233.
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