THOUSAND OAKS, Calif. and
BRUSSELS, Jan. 7, 2018 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that
the European Medicines Agency (EMA) has accepted the Marketing
Authorization Application (MAA) for EVENITY™* (romosozumab) for the
treatment of osteoporosis in postmenopausal women and in men at
increased risk of fracture. If approved in Europe, EVENITY will be a novel osteoporosis
treatment that increases bone formation and reduces bone resorption
simultaneously to increase bone mineral density (BMD) and reduce
the risk of fracture.
"Amgen has a legacy of addressing the needs of patients with
osteoporosis, and EVENITY has the potential to deliver fracture
risk reduction to patients," said Sean E.
Harper, M.D., executive vice president of Research and
Development at Amgen. "Together with UCB, we look forward to
discussing the overall benefit:risk with European regulatory
authorities."
The MAA for EVENITY is based on results from three pivotal Phase
3 studies: FRAME, including 7,180 postmenopausal women with
osteoporosis; ARCH, including 4,093 postmenopausal women with
osteoporosis at high risk for fracture; and BRIDGE, including 245
men with osteoporosis. The agency will evaluate the clinical
benefit:risk profile of EVENITY in these three pivotal studies,
including the potential to increase BMD and reduce the risk of
fractures in women with osteoporosis, as well as the cardiovascular
safety signal seen in the ARCH study.
"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 adequate
management, some fragility fractures may lead to a loss of autonomy
in patients' daily lives," said Dr. Pascale
Richetta, head of bone and executive vice president, UCB.
"At UCB, we are striving to help patients avoid potentially
debilitating fractures and to help close this concerning gap."
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 increase bone formation and
reduce bone resorption simultaneously. EVENITY is being studied for
its potential to reduce the risk of fractures in an extensive
global Phase 3 program. This program includes 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 bone mineral density (BMD) at the lumbar
spine and the effect on BMD at the femoral neck and total
hip.
About Osteoporosis
Osteoporosis is a condition that
weakens bone over time, making them thinner, more brittle and more
likely to break.2 Patients who experience an
osteoporotic fracture are twice as likely to suffer a future
fracture, yet approximately 80 percent of patients are not treated
for underlying osteoporosis after a fracture.3
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 7,500 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
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.
Additionally, information contained in this document shall not
constitute an offer to sell or the solicitation of an offer to buy
any securities, nor shall there be any offer, solicitation or sale
of securities in any jurisdiction in which such offer, solicitation
or sale would be unlawful prior to the registration or
qualification under the securities laws of such jurisdiction. UCB
is providing this information as of the date of this presentation
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.
*The trademark 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
Scott Fleming, Global Communications
Lead, Bone, UCB
T+447702777378, scott.fleming@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
- Nguyen TV, Center JR, Eisman JA (2004) Osteoporosis:
underrated, underdiagnosed and undertreated. Med J Aust
180:S18.
- International Osteoporosis Foundation. What Is Osteoporosis?
2015. Available at:
http://www.iofbonehealth.org/what-is-osteoporosis. Accessed
August 4, 2017.
- International Osteoporosis Foundation. Stop at One. One
Fracture Leads to
Another. http://share.iofbonehealth.org/WOD/2012/patient_brochure/WOD12-patient_brochure.pdf.
Accessed January 3, 2018.
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SOURCE Amgen