THOUSAND OAKS, Calif. and
BRUSSELS, Nov. 30, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN)
and UCB (Euronext Brussels: UCB) today announced the U.S. Food and
Drug Administration (FDA) Bone, Reproductive and Urologic Drugs
Advisory Committee (BRUDAC) will review data supporting the
Biologics License Application (BLA) for EVENITYTM
(romosozumab) for the treatment of osteoporosis in postmenopausal
women at high risk for fracture at a meeting on Jan. 16, 2019.
"After a fracture, postmenopausal women with osteoporosis are
five times more likely to fracture in the subsequent year, and
these fractures can be life-changing. Yet these patients often
remain undiagnosed and untreated and could benefit from a potential
new bone forming therapy that has been shown to reduce their risk
of fracture within the first year," said David M. Reese, M.D., executive vice president
of Research and Development at Amgen. "We look forward to
discussing the efficacy and safety data from our EVENITY clinical
program with the members of the Committee."
The EVENITY development program includes three pivotal Phase 3
studies that included more than 11,000 patients: FRAME,1
including 7,180 postmenopausal women with osteoporosis;
ARCH,2 including 4,093 postmenopausal women with
osteoporosis at high risk for fracture; and BRIDGE,3
including 245 men with osteoporosis. The BRUDAC will focus its
discussion on the FRAME and ARCH studies in its review of the
clinical benefit:risk profile of EVENITY, including the
cardiovascular safety findings seen in the ARCH study, for the
potential to reduce the risk of fractures and increase bone mineral
density (BMD) in postmenopausal women with osteoporosis.
"We are currently seeing a large gap in the management and
treatment of osteoporosis, especially in the post-fracture setting,
with an estimated 77 percent of women aged 67 or older remaining
undiagnosed and untreated in the first six months after a
fracture.4 This is a stark reminder of the need to
improve post-fracture care and reduce the risk of future
fractures," said Dr. Pascale
Richetta, head of bone and executive vice president, UCB.
"We believe EVENITY has the potential to help postmenopausal women
with osteoporosis who are at high risk for fracture, and we look
forward to the interactions with the members of the Committee."
In July 2018, Amgen and UCB
resubmitted the BLA to the FDA for EVENITY. Marketing authorization
applications for EVENITY are also ongoing in other parts of the
world including Europe and
Japan.
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 10,000 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 bone mineral density (BMD) at the lumbar
spine and the effect on BMD at the femoral neck and total hip.
About Fragility Fractures
Worldwide, one in three
women and one in five men, over the age of 50, will suffer a
fragility fracture due to osteoporosis and with an aging population
these numbers will rise.2 Yet despite this, we are
currently seeing 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.1 Without proper care or
access to effective intervention options, they remain at risk of
painful and disabling fractures in the future.
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 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 the world's
largest independent biotechnology company, 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
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liability claims, challenges to patent protection for products or
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fluctuations, changes or uncertainties in tax laws or the
administration of such laws and hiring and retention of its
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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
- Efficacy and Safety of Romosozumab Treatment in Postmenopausal
Women With Osteoporosis (FRAME). Available at:
https://clinicaltrials.gov/ct2/show/NCT01575834?term=NCT01575834&rank=1.
Accessed November 27, 2018.
- Study to Determine the Efficacy and Safety of Romosozumab in
the Treatment of Postmenopausal Women With Osteoporosis. Available
at:
https://clinicaltrials.gov/ct2/show/NCT01631214?term=NCT01631214&rank=1.
Accessed November 27, 2018.
- A Double-blind Study to Compare the Safety and Efficacy of
Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis
(BRIDGE). Available at:
https://clinicaltrials.gov/ct2/show/NCT02186171?term=NCT02186171&rank=1.
Accessed November 27, 2018.
- Cosman F, de Beur SJ, LeBoff MS, et al. Clinician's Guide
to Prevention and Treatment of Osteoporosis. Osteoporos Int. 2014;
25(10): 2359–2381.
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