THOUSAND OAKS, Calif.,
Sept. 28, 2016 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced positive top-line results for
erenumab (AMG 334) from A Phase 3, RandomIzed, double-blind,
placebo-controlled Study to Evaluate the efficacy and safety of
erenumab in migraine prevention (ARISE). These data showed the
ARISE study met the primary endpoint, demonstrating a statistically
significant reduction from baseline in monthly migraine days in
patients with episodic migraine treated with erenumab compared with
placebo at 12 weeks. Erenumab is specifically designed to prevent
migraine by blocking the Calcitonin Gene-Related Peptide (CGRP)
receptor, which is believed to have a critical role in mediating
the incapacitating pain of migraine.
"People with episodic migraine lose a substantial part of their
lives to migraine, and many face intolerable pain and physical
impairment, frequently accompanied by a significant disruption of
their daily activities. Unfortunately, there are limited preventive
treatment options currently available for these patients," said
Sean E. Harper, M.D., executive vice
president of Research and Development at Amgen. "These
positive results, along with the recent chronic migraine
results, contribute to the growing body of evidence
supporting erenumab as an innovative treatment option for people
who are suffering from this debilitating disease."
A total of 577 patients were randomized to receive either
placebo or erenumab 70 mg subcutaneously, once monthly. Patients
enrolled in the ARISE study were experiencing between four and 14
migraine days each month, with an average of eight migraine days
per month at baseline. Those receiving erenumab experienced a
statistically significant 2.9-day reduction from baseline in
monthly migraine days, as compared to a 1.8-day reduction in the
placebo arm.
The safety profile of erenumab was similar to placebo and
consistent with previously reported studies. The most common
adverse events were upper respiratory tract infection, injection
site pain and nasopharyngitis.
Further analysis of these data is ongoing and will be submitted
to a future medical conference and for publication. The STRIVE*
study, a second Phase 3 episodic migraine study evaluating both 70
mg and 140 mg doses for 24 weeks, is expected to be completed by
the end of this year. Positive results from a Phase 2 study of
erenumab in chronic migraine prevention were also announced earlier
this year.
Erenumab is being co-developed by Amgen and Novartis. As part of
the collaboration, Amgen retained commercialization rights in the
U.S., Canada and Japan, and Novartis has rights in Europe and the rest of the world.
*STRIVE is a Phase 3, randomized, double-blind,
placebo-controlled STudy to Evaluate the Efficacy and Safety
of AMG 334 in MigRaIne PreVEntion.
About the ARISE Study
The ARISE study (20120297) is a
global Phase 3, multicenter, randomized, 12-week, double-blind,
placebo-controlled study evaluating the safety and efficacy of
erenumab in episodic migraine prevention. In the study, 577
patients were randomized to receive once-monthly subcutaneous
placebo or erenumab (70 mg) in a 1:1 ratio. Trial participants who
completed the double-blinded portion had the option to continue in
a long-term safety extension. Patients enrolled in ARISE were
experiencing between four to 14 migraine days each month. The
primary endpoint was change in monthly migraine days from baseline
to the last four weeks of the 12-week treatment phase (the number
of migraine days between weeks 9 and 12). Secondary study endpoints
included reduction of at least 50 percent from baseline in monthly
migraine days and change from baseline in monthly acute
migraine-specific medication treatment days. The Migraine Physical
Function Impact Diary (MPFID), a scale developed to measure impact
of migraine on physical function and impact on everyday activities,
assessed two other secondary endpoints.
About Erenumab
Erenumab is a fully human monoclonal
antibody specifically designed for the prevention of migraine.
Erenumab targets and blocks the Calcitonin Gene-Related Peptide
(CGRP) receptor, thought to be pivotal in the genesis of migraine.
Erenumab is currently being studied in several large global,
randomized, double-blind, placebo-controlled trials to assess its
safety and efficacy in migraine prevention.
About Migraine
People with migraine face intolerable
pain and physical impairment, which is frequently accompanied by
nausea, vomiting and significant disruption of daily
activities.1 The World Health Organization
(WHO) ranks migraine as one of the most debilitating illnesses.
Migraine is associated with personal and societal burdens of pain,
disability, and financial cost, and it remains under-recognized and
under-treated with more than 40 percent of people going
undiagnosed.2,3 Worldwide, approximately 90
percent of people diagnosed with migraine have episodic migraine,
which is characterized by up to 14 migraine days a
month.4 The remaining 10 percent have chronic migraine,
which is characterized by at least 15 headache days per months, of
which 8 or more are migraine days, for more than three
months.
About Amgen and Novartis Neuroscience Collaboration
In
August 2015, Amgen entered into a
global collaboration with Novartis to jointly develop and
commercialize pioneering treatments in the field of migraine and
Alzheimer's disease (AD). The collaboration focuses on
investigational Amgen drugs in the migraine field, including
erenumab (currently in Phase 3 studies for episodic migraine) and
AMG 301 (currently in a Phase 1 study). For the migraine program,
Amgen retains commercialization rights in the U.S., Canada and Japan, and Novartis has commercialization
rights in Europe and rest of
world. Also, the companies are partnering in the development and
commercialization of a beta-secretase 1 (BACE) inhibitor program in
AD. Novartis' oral therapy CNP520 (currently in a Phase 2 study for
AD) will be the lead molecule and further compounds from both
companies' pre-clinical BACE inhibitor programs may be considered
as follow-on molecules.
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.
Forward-Looking Statements
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forward-looking statements that are based on the current
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statements of historical fact, are statements that could be deemed
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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
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candidates that are derived from relationships may be subject to
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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
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internationally, clinical and regulatory developments involving
current and future products, sales growth of recently launched
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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
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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
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of new products. Further, some raw materials, medical devices and
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affected products and on our business and results of operations.
Our efforts to acquire other companies or products and to integrate
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We may not be able to access the capital and credit markets on
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dependent on information technology systems, infrastructure and
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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
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CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(investors)
References
1Migraine Research Foundation.
Migraine Fact
Sheet. http://www.migraineresearchfoundation.org/fact-sheet.html.
Accessed March 24, 2016.
2 Vos T et al. Years lived with disability (YLDs) for
1160 sequelae of 289 diseases and injuries 1990–2010: a systematic
analysis for the Global Burden of Disease Study 2010. The
Lancet. 2012 Dec-2013 Jan;30(9859):2163-2196.
3 Steiner TJ et al. Migraine: the seventh disabler. J
Headache Pain. 2013;14(1):1.
4 Stovner L et al. The global burden of headache: a
documentation of headache prevalence and disability worldwide.
Cephalalgia. 2007; 27: 193-210.
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