THOUSAND OAKS, Calif. and
BRUSSELS, Jan. 16, 2019 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced
strong support from the U.S. Food and Drug Administration (FDA)
Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC)
for the approval of EVENITY™* (romosozumab) for the treatment of
postmenopausal women with osteoporosis at high risk for fracture
after reviewing safety and efficacy data from the pivotal Phase 3
studies. Eighteen of 19 members voted yes for approval. In their
discussion, the Committee emphasized the need for post-marketing
follow-up.
"We are pleased with the Committee's recommendation to approve
EVENITY for the treatment of postmenopausal women with osteoporosis
at high risk for fracture," said David M.
Reese, M.D., executive vice president of Research and
Development at Amgen. "A fracture due to osteoporosis can be
devastating to the lives of patients. After an osteoporotic
fracture, a woman is five times more likely to suffer another
fracture within the first year, and her risk remains elevated over
time if untreated.1 Despite available therapies, these
women who are at high risk for fracture could benefit from an
additional treatment option that has the potential to both build
new bone and slow existing bone loss. We are committed to working
with the FDA to help make EVENITY available to appropriate
patients."
The EVENITY development program includes 19 clinical studies
that enrolled approximately 14,000 patients.2 Notable
Phase 3 studies include FRAME,3 a placebo-controlled
study with 7,180 postmenopausal women with osteoporosis at risk for
fracture; ARCH,4 an active comparator-controlled study
with 4,093 postmenopausal women with osteoporosis and with prior
history of fracture; and STRUCTURE,5 an active
comparator-controlled study with 436 postmenopausal women with
osteoporosis. The BRUDAC evaluated the FRAME and ARCH studies in
its review of the clinical benefit:risk profile of EVENITY,
including the cardiovascular safety finding 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.
"Evidence suggests that many women who sustain a fragility
fracture are not appropriately treated for osteoporosis. This is
why new treatment options, like EVENITY, are so important," said
Dr. Pascale Richetta, head of bone
and executive vice president, UCB. "The Committee's recommendation
represents a step forward for patients and we look forward to
working with our partner, Amgen, in the coming months to bring
EVENITY to the patients that need it most."
While the FDA is not bound by the Advisory Committee's
recommendations, it takes the advice into consideration when making
its decision.
In the U.S., one in two women over the age of 50 will experience
an osteoporotic fracture.6 Unfortunately, only 20
percent of women who have experienced a fracture receive any type
of osteoporosis treatment during the first year
post-fracture.7
EVENITY was granted marketing authorization – its first approval
anywhere in the world – by the Japanese Ministry of Health, Labor
and Welfare on Jan. 8, 2019, for the
treatment of osteoporosis in patients at high risk of
fracture.8 The European Medicines Agency (EMA) is
currently reviewing the marketing application for EVENITY and
interactions between our partner and the agency are ongoing.
About EVENITY™* (romosozumab)
EVENITY is an
investigational bone-forming monoclonal antibody. It is designed to
work by inhibiting the activity of sclerostin, which enables
EVENITY to rapidly increase bone formation and reduce bone
resorption simultaneously. The EVENITY development program includes
19 clinical studies that enrolled approximately 14,000 patients.
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 at risk for fracture.
The study evaluated the effectiveness of EVENITY treatment (210 mg
administered monthly), 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 administered monthly) followed by at
least 12 months of alendronate treatment (70 mg), compared with
alendronate treatment alone, to assess its effectiveness in
reducing the incidence of clinical fracture (non-vertebral fracture
and clinical vertebral fracture) and new vertebral fracture.
About the STRUCTURE Clinical Trial
STRUCTURE (Study
evaluating effect of romosozumab compared
with teriparatide in postmenopausal women with osteoporosis at
high risk for fracture previously treated with
bisphosphonate therapy) is 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. The trial
included 436 postmenopausal women averaging 72 years of age who had
postmenopausal osteoporosis and a history of bone fracture;
patients were treated with bisphosphonate therapy for a minimum of
three years prior to screening, with treatment with alendronate (70
mg weekly or equivalent) during the year immediately prior to
screening.
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.9 Yet despite this, there
is 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.7 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 7,500 people in approximately 40 countries, the
company generated revenue of € 4.5 billion in 2017. UCB is listed
on Euronext Brussels (symbol: UCB). Follow us on Twitter:
@UCB_news
Amgen Forward-Looking Statements
This news release
contains forward-looking statements that are based on the current
expectations and beliefs of Amgen. 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
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Amgen is providing this information as of the date of this news
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of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those Amgen projects. 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
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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
Amgen to complete clinical trials and obtain regulatory approval
for product marketing has in the past varied and Amgen expects
similar variability in the future. Even when clinical trials are
successful, regulatory authorities may question the sufficiency for
approval of the trial endpoints Amgen has selected. Amgen develops
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 Amgen may
have believed at the time of entering into such relationship. Also,
Amgen or others could identify safety, side effects or
manufacturing problems with its products, including its devices,
after they are on the market.
Amgen's results may be affected by its ability to successfully
market both new and existing products domestically and
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current and future products, sales growth of recently launched
products, competition from other products including biosimilars,
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affected by pricing pressure, political and public scrutiny and
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
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Amgen routinely obtains patents for its products and technology,
the protection offered by its patents and patent applications may
be challenged, invalidated or circumvented by its competitors, or
Amgen may fail to prevail in present and future intellectual
property litigation. Amgen performs a substantial amount of its
commercial manufacturing activities at a few key manufacturing
facilities, including in Puerto
Rico, and also depends on third parties for a portion of its
manufacturing activities, and limits on supply may constrain sales
of certain of its current products and product candidate
development. In addition, Amgen competes with other companies with
respect to many of its marketed products as well as for the
discovery and development of new products. Further, some raw
materials, medical devices and component parts for Amgen's products
are supplied by sole third-party suppliers. Certain of Amgen's
distributors, customers and payers have substantial purchasing
leverage in their dealings with Amgen. The discovery of significant
problems with a product similar to one of Amgen's products that
implicate an entire class of products could have a material adverse
effect on sales of the affected products and on its business and
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or products and to integrate the operations of companies Amgen has
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information security breach could compromise the confidentiality,
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Amgen's stock price may be volatile and may be affected by a number
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ability of the Amgen Board of Directors to declare a dividend or
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may not be able to access the capital and credit markets on terms
that are favorable to it, or at all.
The scientific information discussed in this news release
related to Amgen's 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.
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.
*The trade name EVENITY™ is provisionally approved for use by
the FDA and EMA.
CONTACT: Amgen, Thousand
Oaks
Kelley Davenport, 202-585-9637
(media)
Kristen Davis, 805-447-3008
(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
- Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral
fracture in the year following fracture. JAMA.
2001;285(3):320-323.
- FDA Briefing Document. Meeting of the Bone, Reproductive and
Urologic Drugs Advisory Committee. January
16, 2019. BLA 761062 Romosozumab Amgen, Inc. Available at:
https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM629456.pdf.
Accessed January 14, 2019.
- 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 January 14, 2019.
- Study to Determine the Efficacy and Safety of Romosozumab in
the Treatment of Postmenopausal Women With Osteoporosis (ARCH).
Available
at: https://clinicaltrials.gov/ct2/show/NCT01631214?term=NCT01631214&rank=1.
Accessed January 14, 2019.
- An Open-label Study to Evaluate the Effect of Treatment With
Romosozumab or Teriparatide in Postmenopausal Women (STRUCTURE).
Available at:
https://clinicaltrials.gov/ct2/show/NCT01796301?term=STRUCTURE+ROMOSOZUMAB&rank=1.
Accessed January 14, 2019.
- National Osteoporosis Foundation. Osteoporosis Fast Facts.
https://cdn.nof.org/wp-content/uploads/2015/12/Osteoporosis-Fast-Facts.pdf.
Accessed January 14, 2019.
- International Osteoporosis Foundation. Facts and Statistics.
https://www.iofbonehealth.org/facts-statistics.
Accessed January 14, 2019.
- Amgen Astellas BioPharma (2018) Evenity subcutaneous injection
105mg syringe: 2 syringes. [package insert] Tokyo, Japan.
- International Osteoporosis Foundation. Patient Brochure.
http://share.iofbonehealth.org/WOD/2012/patient_brochure/WOD12-patient_brochure.pdf.
Accessed January 14, 2019.
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