THOUSAND OAKS, Calif.,
Nov. 16, 2016 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced positive top-line results for
erenumab from a global Phase 3, randomized, double-blind,
placebo-controlled STudy to evaluate the efficacy and safety
of erenumab in migRaIne preVEntion (STRIVE).
These data showed the STRIVE study met the primary endpoint,
demonstrating statistically significant reductions from baseline in
monthly migraine days in patients with episodic migraine treated
with either 70 mg or 140 mg erenumab compared with placebo.
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.
"Migraine is ranked one of the most debilitating diseases by the
World Health Organization, yet it is often under-diagnosed and
under-treated. People who experience migraine battle the disease
for many years and it has significant impact on their everyday
activities," said Sean E. Harper,
M.D., executive vice president of Research and Development at
Amgen. "The results of this study are important because they
confirm the results from our previous studies and add to our body
of research in episodic migraine. We look forward to working with
regulatory authorities to pursue approval of erenumab and making
this novel migraine prevention treatment available to patients and
physicians."
Patients enrolled in STRIVE were randomized to receive either
placebo, or one of two erenumab doses – 70 mg or 140 mg –
subcutaneously, once monthly for six months. At baseline, patients
were experiencing an average of 8.3 migraine days per month.
Patients in the erenumab 70 mg and 140 mg treatment arms
experienced reductions of 3.2 and 3.7 days from baseline in monthly
migraine days, respectively, as compared to a 1.8-day reduction in
the placebo arm.These results were statistically significant.
The safety profile of erenumab was comparable to placebo across
both treatment arms and was consistent with previously reported
studies. The most frequently reported adverse events were
nasopharyngitis, upper respiratory tract infection and
sinusitis.
Further analysis of STRIVE data is ongoing and will be submitted
to a future medical conference and for publication.
Two other positive trials—ARISE, a Phase 3 study of erenumab in
episodic migraine prevention, and the Phase 2 study of erenumab in
chronic migraine prevention—were announced earlier this year.
Combined together, almost 2,200 patients with chronic and episodic
migraine have participated in these three erenumab clinical trials.
These data will help support discussions with regulatory agencies,
with filing anticipated in 2017.
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 rest of world.
About STRIVE
STRIVE (20120296) is a global Phase 3,
multicenter, randomized 24-week, double-blind, placebo-controlled
study evaluating the safety and efficacy of erenumab in episodic
migraine prevention. In the study, 955 patients were randomized to
receive once-monthly subcutaneous placebo or erenumab (70 mg or 140
mg) in a 1:1:1 ratio. Patients enrolled in STRIVE were experiencing
an average of 8.3 migraine days per month. The primary endpoint was
change in mean monthly migraine days from baseline over the last
three months of the double-blind treatment phase of the study
(months 4, 5, 6). Secondary study endpoints assessed at six months
included reduction of at least 50 percent from baseline in mean
monthly migraine days, change from baseline in mean monthly acute
migraine-specific medication days, and reductions from baseline in
both mean impact on everyday activities domain and mean physical
impairment domain scores on the Migraine Physical Function Impact
Diary (MPFID).
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 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 ranks
migraine as one of the most debilitating illnesses.2
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.3,4 Worldwide, approximately 90 percent of
people diagnosed with migraine have episodic migraine, which is
characterized by up to 14 migraine days a month.5,6 The
remaining 10 percent have chronic migraine, which is characterized
by at least 15 headache days per month, of which eight 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 as
well as open-label studies in episodic and chronic 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
This news release contains
forward-looking statements that are based on the current
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statements of historical fact, are statements that could be deemed
forward-looking statements, including estimates of revenues,
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estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed
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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
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Our results may be affected by our ability to successfully
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Further, while we routinely obtain patents for our products and
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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
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of new products. Further, some raw materials, medical devices and
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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
terms that are favorable to us, or at all. We are increasingly
dependent on information technology systems, infrastructure and
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number of events. Our business performance could affect or limit
the ability of our Board of Directors to declare a dividend or our
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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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the safety or effectiveness of the product candidates.
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
November 2, 2016.
2 World Health Organization. Headache disorders.
http://www.who.int/mediacentre/factsheets/fs277/en/. Accessed
November 2, 2016.
3 GBD 2015 Disease and Injury Incidence and Prevalence
Collaborators. Global, regional, and national incidence,
prevalence, and years lived with disability for 310 diseases and
injuries, 1990-2015: a systematic analysis for the Global Burden of
Disease Study 2015. Lancet. 2016; 388: 1545–602.
4 Diamond S et al. Patterns of diagnosis and acute and
preventive treatment for migraine in the
United States: results from the American Migraine Prevalence
and Prevention Study. Headache. 2007; 47:355-363.
5 Stovner L et al. The global burden of headache: a
documentation of headache prevalence and disability worldwide.
Cephalalgia. 2007; 27: 193-210.
6 Headache Classification Committee of the International
Headache Society (IHS). Cephalalgia. 2013;33:629-808.
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