THOUSAND OAKS, Calif. and
BRUSSELS, Belgium, Jan. 8, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN)
and UCB (Euronext Brussels: UCB) today announced that the Japanese
Ministry of Health, Labor and Welfare has granted a marketing
authorization for EVENITY™ (romosozumab) for the treatment of
osteoporosis in patients at high risk of fracture.1
Amgen and UCB are co-developing EVENITY worldwide, with development
in Japan being led by Amgen
Astellas BioPharma K.K., a joint venture between Amgen and Astellas
Pharma Inc., headquartered in Tokyo.
"The approval of EVENITY in Japan is a significant milestone that
reinforces our commitment to bringing effective treatments to the
millions of patients who suffer from osteoporosis," said
David M. Reese, M.D., executive vice
president of Research and Development at Amgen. "A patient
with a prior osteoporotic fracture is twice as likely to suffer
another fracture if left undiagnosed and without appropriate
treatment.2 With this approval, physicians in
Japan now have a new medicine to
help patients reduce their risk of fracture."
EVENITY is a bone forming agent that both increases bone
formation and reduces bone resorption to increase bone mineral
density (BMD) and reduce the risk of fracture. The approval is
based on results from two pivotal Phase 3 studies:
FRAME,3 which included 7,180 postmenopausal women with
osteoporosis, and BRIDGE,4 which included 245 men with
osteoporosis. The Japanese Pharmaceuticals and Medical Devices
Agency undertook a thorough review of the safety profile of
EVENITY, including the cardiovascular safety findings in the ARCH
trial.
"In Japan, osteoporotic fracture is one of the leading causes
for patients losing independence and needing nursing care. As the
aged population of Japan
increases, preventing such fractures should be given high
priority," said Steve Sugino, Amgen
vice president and president and representative director of AABP.
"Japanese patients will be the first in the world to have a new
therapeutic option for osteoporosis that reduces the risk of
fracture by not only increasing bone formation but also decreasing
bone resorption."1
"Patients with a prior fracture face the risk of having another
fracture and particularly stand to benefit from the option of a new
bone-forming agent," said Toshio
Matsumoto, M.D., Ph.D., emeritus professor of Tokushima
University and the advisor of the university's Fujii Memorial
Institute of Medical Sciences. "Physicians have been waiting for a
new therapeutic option. I have great hope that the approval of
EVENITY will help reduce the fracture risk for patients in
Japan."
Japan has one of the longest
life expectancy rates in the world, and it is believed that by
2050, over 37 percent of the population will be aged 60 or older.
5 Age is one of the most common risk factors associated
with developing osteoporosis, as bone mass is lost over
time.6,7 Today, the prevalence of osteoporosis in
the country is around 12 million, and the hip fracture incidence
rate in the population over 75 is increasing dramatically in both
men and women.8
"With one of the longest life expectancy rates in the world,
Japan is a country of longevity,
but this means that the rate of osteoporosis will increase, leaving
many people at high risk for fracture due to the condition," said
Dr. Pascale Richetta, head of bone and executive vice
president, UCB. "We are proud that EVENITY is now approved as a new
treatment to help address this important public health issue and
help people with their osteoporosis."
This is the first approval for EVENITY in the world, and the
third approval of a new medicine through AABP.
The U.S. Food and Drug Administration (FDA) and the European
Medicines Agency (EMA) are currently reviewing marketing
applications for EVENITY and interactions with the agencies are
ongoing.
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 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.9 Without
proper care or access to effective intervention options, they
remain at risk of painful and disabling fractures in the
future.
About EVENITY™ (romosozumab)
EVENITY is an bone-forming monoclonal antibody approved in
Japan.. It is designed to work by
inhibiting the activity of sclerostin, which enables EVENITY to
both 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.
Important Japan Product Information
Product Name:
EVENITY® subcutaneous injection 105mg syringe
Generic Name:
Romosozumab (Genetical Recombination) Injection
Indication:
Osteoporosis at high risk of fracture
Dosage and Administration:
The usual adult dosage is 210 mg as romosozumab (genetical
recombination) by subcutaneous injection once a month for 12
months.
For more information, see the Japan Package Inserts.
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.
About Amgen Astellas BioPharma K.K.
Amgen Astellas BioPharma K.K. (AABP) is a Japanese company that
began operations on Oct. 1, 2013, to
provide breakthrough-science-based medicines to help address unmet
medical needs of patients in Japan. The company is a joint venture between
Amgen, one of the world's leading independent biotechnology
companies, and Astellas Pharma Inc., a leading Tokyo-based R&D oriented global
pharmaceutical company.
AABP has grown into an organization with over 400 employees and
comprehensive functions to be fully operational as a marketing
authorization holder in Japan. AABP's sales organization,
with 19 regional sales offices located throughout Japan, will co-promote its products with
Astellas. The joint venture will become a wholly-owned Amgen
affiliate as soon as 2020.
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
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. All
statements, other than statements of historical fact, are
statements that could be deemed forward-looking statements,
including estimates of revenues, operating margins, capital
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No forward-looking statement can be guaranteed and actual
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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,
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necessary regulatory approvals or to obtain them on acceptable
terms, costs associated with research and development, changes in
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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
Trish Hawkins, 805-447-5631
(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
1. Pharmaceuticals and Medical Devices Agency Prescription Drug
Database http://www.info.pmda.go.jp/go/pack/39994C7G1022_1_02/
2. International Osteoporosis Foundation. Patient Brochure.
http://share.iofbonehealth.org/WOD/2012/patient_brochure/WOD12-pa-tient_brochure.pdf.
Accessed December 6, 2018.
3. 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 2018.
4. 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 2018, 2016.
5. Population projections for Japan, 2001-2050, The
National Institute of Population and Social Security Research,
2002.
6. Kanis JA, Johnell O, Odén A, Dawson A, De LAet C, Jonsson B. Ten year probabilities of
osteoporotic fractures according to BMD and diagnosis thresholds.
Osteoporosis Int 2001;12:989-95
7. International Osteoporosis Foundation. Fixed Risk Factors.
Available at http://www.iofbonehealth.org/fixed-risk-factors.
Accessed November 2018
8. International Osteoporosis Foundation.
Asian_regional_audit_Japan. Available at:
https://www.iofbonehealth.org/sites/default/files/PDFs/Audit%20Asia/Asian_regional_audit_Japan.pdf.
Accessed November 2018.
9. International Osteoporosis Foundation. Facts and Statistics.
Available at https://www.iofbonehealth.org/facts-statistics.
Accessed December 17, 2018.
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SOURCE Amgen