THOUSAND OAKS, Calif. and
BRUSSELS, July 12, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN)
and UCB (Euronext Brussels: UCB) today announced the resubmission
of the Biologics License Application (BLA) to the U.S. Food and
Drug Administration (FDA) for EVENITY™* (romosozumab), an
investigational monoclonal antibody for the treatment of
osteoporosis in postmenopausal women at high risk for fracture.
EVENITY increases bone formation and reduces bone resorption
simultaneously to increase bone mineral density (BMD) and reduce
the risk of fracture.
"A fracture due to osteoporosis can be a life-altering event,
and EVENITY has the potential to reduce fracture risk in patients
at high risk due to a prior fracture," said Sean E. Harper, M.D., executive vice president
of Research and Development at Amgen. "We look forward to
continuing our work with the FDA to demonstrate the benefit:risk
profile for EVENITY. Our hope is to bring to patients an innovative
treatment option that addresses a serious unmet medical need."
The BLA for EVENITY now adds results from two more recent
pivotal Phase 3 trials: the ARCH study, an alendronate-active
comparator trial including 4,093 postmenopausal women with
osteoporosis who experienced a fracture, and the BRIDGE study,
including 245 men with osteoporosis. The FDA will evaluate the
clinical benefit:risk profile of EVENITY, including the
cardiovascular safety signal seen in the ARCH study, for the
potential to reduce the risk of fractures and increase BMD in
postmenopausal women with osteoporosis. The original FDA submission
included data from a comprehensive Phase 1 and Phase 2 program and
the Phase 3 placebo-controlled FRAME study, including 7,180
postmenopausal women with osteoporosis.
"The burden of osteoporosis can have tremendous impact on a
patient's life," said Pascale
Richetta, M.D., head of bone and executive vice president at
UCB. "We are one step closer in our ability to bring this first of
its kind treatment to thousands of women affected by fragility
fractures each year."
In the U.S., one in two women over the age of 50 will suffer a
fragility (or osteoporotic) fracture due to osteoporosis, and with
an aging population these numbers will likely rise.1 Yet
despite this, there is currently a large gap in the management and
treatment of osteoporosis, especially in the post-fracture setting,
with an estimated four out of five patients remaining undiagnosed
and untreated after a fracture.2 Without proper care or
access to effective intervention options, they remain at risk of
painful and disabling fractures in the future.
The European Medicines Agency (EMA) and the Pharmaceuticals and
Medical Device Agency (PMDA) in Japan are currently reviewing marketing
applications for EVENITY and interactions with the agencies are
ongoing.
About EVENITY™* (romosozumab)
EVENITY 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 activity of
sclerostin, which enables EVENITY to rapidly increase bone
formation and reduce bone resorption simultaneously. EVENITY has
been studied for its potential to reduce the risk of fractures in
an extensive global Phase 3 program. This program included two
large fracture trials comparing EVENITY to either placebo or active
comparator in more than 11,000 postmenopausal women with
osteoporosis. Amgen and UCB are co-developing
EVENITY.
About the Pivotal EVENITY Clinical Trials
FRAME
(FRActure study in postmenopausal woMen with
ostEoporosis) is a randomized, double-blind,
placebo-controlled study that evaluated 7,180 postmenopausal women
with osteoporosis. The study evaluated the effectiveness of EVENITY
treatment (210 mg), compared with placebo, in reducing the risk of
new vertebral fractures through 12 months. The study also evaluated
the effectiveness of treating with EVENITY for 12 months followed
by denosumab for 12 months, compared with placebo followed by
denosumab, in reducing the risk of new vertebral fractures through
24 months.
ARCH (Active-contRolled fraCture study in
postmenopausal women with osteoporosis at High risk of
fracture) is a randomized, double-blind, alendronate-controlled
study of EVENITY in 4,093 postmenopausal women with osteoporosis at
high risk for fracture based on previous fracture history. The
study evaluated 12 months of EVENITY treatment (210 mg) followed by
at least 12 months of alendronate treatment (70 mg), compared with
alendronate treatment alone, to determine effectiveness in reducing
the incidence of clinical fracture (non-vertebral fracture and
clinical vertebral fracture) and new vertebral fracture.
BRIDGE (placeBo-contRolled study evaluatIng
the efficacy anD safety of romosozumab in
treatinG mEn with osteoporosis) is a randomized,
double-blind, placebo-controlled study of 245 men aged 55-90 years
with osteoporosis and a history of fragility fracture (excluding
hip fracture) or vertebral fracture. The study evaluated the
effectiveness of EVENITY treatment for 12 months, compared with
placebo, in increasing BMD at the lumbar spine and the effect on
BMD at the femoral neck and total hip.
About the Amgen and UCB Collaboration
Since
2004, Amgen and UCB have been working together under a
collaboration and license agreement to research, develop and market
antibody products targeting the protein sclerostin. As part of this
agreement, the two companies continue to collaborate on the
development of romosozumab for the treatment of osteoporosis. This
gene-to-drug project demonstrates how Amgen and UCB are
joining forces to translate a genetic discovery into a new
medicine, turning conceptual science into a reality.
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 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.
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 7,700 people in
approximately 40 countries, the company generated revenue of € 4.2
billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB).
Follow us on Twitter: @UCB_news
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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
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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.
*The trade name EVENITY™ is provisionally approved for use by
the U.S. Food and Drug Administration and
the European Medicines Agency.
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
Isabelle Ghellynck, Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com
References
1 National
Osteoporosis Foundation. What is Osteoporosis and What Causes It?
https://nof.org/patients/what-is-osteoporosis. Accessed
June 28, 2018.
2 Nguyen TV, Center JR, Eisman JA (2004) Osteoporosis:
underrated, underdiagnosed and undertreated. Med J Aust.
180:S18.
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