THOUSAND OAKS, Calif. and
BRUSSELS, July 22, 2016 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced the
submission of a Biologics License Application (BLA) to the U.S.
Food and Drug Administration (FDA) for romosozumab, an
investigational monoclonal antibody for the treatment of
osteoporosis in postmenopausal women at increased risk of fracture.
Romosozumab works by binding and inhibiting sclerostin, a protein
naturally occurring in the bone, thereby increasing bone formation
and decreasing bone resorption.
"Osteoporosis is a large public health problem yet is often
overlooked, even in patients who have already experienced an
osteoporotic fracture,"1,2 said Sean E. Harper, M.D., executive vice president
of Research and Development at Amgen. "This BLA submission is an
exciting milestone; romosozumab has the potential to reduce the
risk of fractures and help patients suffering from this serious
disease."
The BLA for romosozumab is based on data from the pivotal Phase
3 placebo-controlled FRActure study in postemenopausal
woMen with ostEoporosis (FRAME) in approximately
7,200 patients. Amgen and UCB plan to present results from the
FRAME clinical trial at an upcoming medical congress.
"Osteoporosis is a chronic disease, largely asymptomatic, and
often undetected until a fragility fracture occurs.1,3,4
Many patients often view fragility fractures as part of
aging,5 but these fractures are an indication of a
weakened skeleton and a signal for intervention with medication,"
said Dr. Pascale Richetta, head of
bone and executive vice president, UCB. "We are pleased to submit
the first regulatory submission for romosozumab and are
committed to seeking global regulatory approvals in the hopes of
making this important therapy available for appropriate patients at
increased risk of fracture."
Osteoporosis-related fragility fractures are
common.1,6 In the United
States, one in two women over the age of 50 will experience
an osteoporotic fracture.7 Data shows that only 20
percent of women who have experienced a fracture receive any type
of osteoporosis treatment during the first year post
fracture.1
About Romosozumab
Romosozumab is an investigational
bone-forming agent and is not approved by any regulatory authority
for the treatment of osteoporosis. It is designed to work by
inhibiting the protein sclerostin, and has a dual effect on bone,
both increasing bone formation and decreasing bone breakdown.
Romosozumab 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 romosozumab to either
placebo or active comparator in more than 10,000 postmenopausal
women with osteoporosis. Amgen and UCB are co-developing
romosozumab.
About the FRAME study
FRAME is a multi-center,
international, randomized, double-blind, placebo-controlled,
parallel-group study in postmenopausal women with osteoporosis,
defined as low bone mineral density at the total hip or femoral
neck. The study evaluated the effectiveness of romosozumab
treatment, compared with placebo, in reducing the risk of new
vertebral fractures through 12 months. The study also further
evaluated if romosozumab treatment for 12 months followed by
denosumab treatment for 12 months, compared with placebo followed
by denosumab treatment, was effective in reducing the risk of new
vertebral fractures through 24 months. In addition, clinical
fracture (a composite endpoint of non-vertebral and symptomatic
vertebral fractures) risk reduction, non-vertebral fracture
(fractures outside of the spine, excluding sites that are not
considered osteoporotic, fractures due to high trauma or pathologic
fractures) risk reduction and other endpoints were assessed at 12
and 24 months. The most common adverse reactions (greater than or
equal to 10 percent) reported in the Phase 3 FRAME study were
arthralgia and nasopharyngitis.
7,180 patients were randomized 1:1 to receive either 210 mg
romosozumab subcutaneous (SC) monthly (QM) or placebo SC QM for the
12-month double-blind study period. After the placebo-controlled
study period, patients entered the open-label phase where all
patients received 60 mg denosumab SC every six months (Q6M) for 12
months, while remaining blinded to initial treatment. An additional
12 month extension period of open-label 60 mg denosumab SC Q6M is
currently ongoing.
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 € 3.9 billion in 2015. 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
practices, reimbursement activities and outcomes and other such
estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed
below and more fully described in the Securities and Exchange
Commission reports filed by Amgen, including our most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and Form 8-K. Unless otherwise noted, Amgen is providing
this information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future
events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project.
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 guarantee safe and effective
performance of product candidates in 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 us to complete clinical trials and
obtain regulatory approval for product marketing has in the past
varied and we expect similar variability in the future. Even when
clinical trials are successful, regulatory authorities may question
the sufficiency for approval of the trial endpoints we have
selected. We develop 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 we may have believed at the time of entering into such
relationship. Also, we or others could identify safety, side
effects or manufacturing problems with our products after they are
on the market.
Our results may be affected by our ability to successfully
market both new and existing products domestically and
internationally, clinical and regulatory developments involving
current and future products, sales growth of recently launched
products, competition from other products including biosimilars,
difficulties or delays in manufacturing our products and global
economic conditions. In addition, sales of our products are
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
healthcare cost containment. Furthermore, our research, testing,
pricing, marketing and other operations are subject to extensive
regulation by domestic and foreign government regulatory
authorities. We or others could identify safety, side effects or
manufacturing problems with our products after they are on the
market. Our business may be impacted by government investigations,
litigation and product liability claims. In addition, our business
may be impacted by the adoption of new tax legislation or exposure
to additional tax liabilities. If we fail to meet the compliance
obligations in the corporate integrity agreement between us and the
U.S. government, we could become subject to significant sanctions.
Further, while we routinely obtain patents for our products and
technology, the protection offered by our patents and patent
applications may be challenged, invalidated or circumvented by our
competitors, or we may fail to prevail in present and future
intellectual property litigation. We perform a substantial amount
of our commercial manufacturing activities at a few key facilities
and also depend on third parties for a portion of our manufacturing
activities, and limits on supply may constrain sales of certain of
our current products and product candidate development. In
addition, we compete with other companies with respect to many of
our marketed products as well as for the discovery and development
of new products. Further, some raw materials, medical devices and
component parts for our products are supplied by sole third-party
suppliers. The discovery of significant problems with a product
similar to one of our products that implicate an entire class of
products could have a material adverse effect on sales of the
affected products and on our business and results of operations.
Our efforts to acquire other companies or products and to integrate
the operations of companies we have acquired may not be successful.
We may not be able to access the capital and credit markets on
terms that are favorable to us, or at all. We are increasingly
dependent on information technology systems, infrastructure and
data security. Our stock price is volatile and may be affected by a
number of events. Our business performance could affect or limit
the ability of our Board of Directors to declare a dividend or our
ability to pay a dividend or repurchase our common stock.
The scientific information discussed in this news release
related to our 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.
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
1 Reginster JY, Burlet N. Osteoporosis: A still
increasing prevalence. Bone. 2006 Feb;38 (2 Suppl
1):S4-9.
2 Wilk A et al. Post-fracture pharmacotherapy for women
with osteoporotic fracture: analysis of a managed care population
in the USA. Osteoporosis
Int. 2014;25(12):2777-2786.
3 International Osteoporosis Foundation. The Global
Burden of Osteoporosis. What you need to know. Available at:
http://www.iofbonehealth.org/data-publications/fact-sheets/what-you-need-know-about-osteoporosis.
Accessed July 14, 2016.
4 International Osteoporosis Foundation. Who's at Risk?
2015. Available at: https://www.iofbonehealth.org/whos-risk.
Accessed July 15, 2016.
5 National Osteoporosis Foundation. What Women Need To
Know. Available at:
www.nof.org/prevention/general-facts/what-women-need-to-know.
Accessed July 15, 2016.
6 American Academy of Orthopaedic Surgeons. Position
Statement: Osteoporosis/Bone Health in Adults as a National Public
Health Priority. December 2014.
Available at: www.aaos.org/about/papers/position/1113.asp. Accessed
July 14, 2016.
7 National Osteoporosis Foundation. What Is Osteoporosis
and What Causes It? Available at:
https://www.nof.org/patients/what-is-osteoporosis. Accessed
July 15, 2016.
Logo - http://photos.prnewswire.com/prnh/20081015/AMGENLOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/amgen-and-ucb-submit-biologics-license-application-for-romosozumab-to-the-fda-300302620.html
SOURCE Amgen