THOUSAND OAKS, Calif. and
BRUSSELS, Sept. 26, 2016 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that
the U.S. Food and Drug Administration (FDA) has accepted for review
the Biologics License Application (BLA) 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 the activity of the
protein sclerostin, a protein naturally occurring in the bone,
thereby increasing bone formation and decreasing bone
resorption.
"We believe romosozumab could serve as an important therapeutic
option for osteoporosis patients with an increased risk of
fracture," said Sean E. Harper,
M.D., executive vice president of Research and Development at
Amgen. "We look forward to potentially providing a new therapy to
address a critical unmet medical need and further supporting
patients worldwide."
The BLA, submitted on July 19,
2016, is based on data from the pivotal Phase 3
placebo-controlled FRActure study in postmenopausal
woMen with ostEoporosis (FRAME) in approximately
7,200 patients.
"Once a patient suffers a fragility fracture, the burden of
osteoporosis can have a tremendous impact on a patient's
life,"1,2 said Dr. Pascale
Richetta, head of bone and executive vice president, UCB.
"We are pleased with the FDA's acceptance of the BLA filing for
review and hope to continue the regulatory process towards U.S.
approval to introduce a potential therapy to reduce the risk of
fractures for this patient population."
The FDA has set a Prescription Drug User Fee Act (PDUFA) target
action date of July 19, 2017, for
romosozumab.
About Romosozumab
Romosozumab is an investigational
bone-forming monoclonal agent and is not approved by any regulatory
authority for the treatment of osteoporosis. It is designed to work
by inhibiting the activity of 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 multicenter,
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 which encompasses all symptomatic
fractures, both non-vertebral and painful 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.
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 its 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 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
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
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 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
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 its products and global
economic conditions. In addition, sales of Amgen's 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, Amgen's research,
testing, pricing, marketing and other operations are subject to
extensive regulation by domestic and foreign government regulatory
authorities. Amgen or others could identify safety, side effects or
manufacturing problems with its products after they are on the
market. Amgen's business may be impacted by government
investigations, litigation and product liability claims. In
addition, Amgen's business may be impacted by the adoption of new
tax legislation or exposure to additional tax liabilities. If Amgen
fails to meet the compliance obligations in the corporate integrity
agreement between it and the U.S. government, Amgen could become
subject to significant sanctions. Further, while 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 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. 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 results of
operations. Amgen's efforts to acquire other companies or products
and to integrate the operations of companies Amgen has acquired may
not be successful. Amgen may not be able to access the capital and
credit markets on terms that are favorable to it, or at all. Amgen
is increasingly dependent on information technology systems,
infrastructure and data security. Amgen's stock price may be
volatile and may be affected by a number of events. Amgen's
business performance could affect or limit the ability of the Amgen
Board of Directors to declare a dividend or its ability to pay a
dividend or repurchase its common stock.
The scientific information discussed in this news release
relating to new indications for Amgen's products is preliminary and
investigative and is not part of the labeling approved by the U.S.
Food and Drug Administration for the products. The products are not
approved for the investigational use(s) discussed in this news
release, and no conclusions can or should be drawn regarding the
safety or effectiveness of the products for these uses.
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
References:
1 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.
2International Osteoporosis Foundation. Who's at Risk?
2015. Available at: http://www.iofbonehealth.org/whos-risk.
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-announce-us-fda-acceptance-of-biologics-license-application-for-romosozumab-300334171.html
SOURCE Amgen