THOUSAND OAKS, Calif.,
June 8, 2016 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced positive top-line
results from the global Phase 2 study evaluating the efficacy and
safety of erenumab (AMG 334) in chronic migraine prevention. The
study met its primary endpoint of change in monthly migraine days.
The reduction in migraine days was statistically significant for
both the 70 mg and 140 mg doses.
"Migraine is the sixth leading cause of disability worldwide.
Three to seven million Americans spend more than half of each month
living with the debilitating symptoms of chronic migraine,"
said Sean E. Harper, M.D., executive vice president of
Research and Development at Amgen. "These positive results are
exciting because they add to the growing body of evidence
supporting erenumab for the prevention of migraine. We look forward
to Phase 3 episodic migraine data later this year."
At baseline, patients enrolled in this study were experiencing
approximately 18 migraine days per month. Patients were randomized
to receive either placebo, or one of two erenumab doses — 70 mg or
140 mg — subcutaneously, once monthly. Patients experienced a
6.6-day reduction from baseline in monthly migraine days in each of
the erenumab treatment arms as compared to a 4.2-day reduction in
the placebo arm, a statistically significant reduction in each
erenumab treatment arm.
The safety profile of erenumab was similar to placebo across
both treatment arms. No adverse event was reported in greater than
five percent of patients treated with erenumab; the most common
adverse events were injection site pain, upper respiratory tract
infection and nausea.
Additional analyses of these data are ongoing and will be
submitted to a future medical meeting and for publication.
About the 20120295 Study
The 20120295 study is a
global Phase 2, randomized, 12-week, double-blind,
placebo-controlled study evaluating the safety and efficacy of
erenumab in chronic migraine prevention. In the study, 667 patients
were randomized to receive once-monthly subcutaneous placebo or
erenumab (70 mg or 140 mg) in a 3:2:2 ratio, respectively. The
primary endpoint was change in monthly migraine days from baseline
to the last four weeks of the 12-week treatment phase in patients
with chronic migraine (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,
change from baseline in monthly acute migraine-specific medication
days and change from baseline in cumulative monthly headache
hours.
About Erenumab
Erenumab is a fully human monoclonal
antibody under investigation for the prevention of migraine.
Erenumab specifically targets the Calcitonin-Gene-Related-Peptide
(CGRP) receptor, which is believed to transmit signals that can
cause incapacitating pain. Erenumab is currently under evaluation
in several large global, randomized, double-blind,
placebo-controlled trials to assess its safety and efficacy in
migraine prevention.
About Migraine
Migraine involves incapacitating head
pain and physical impairment, frequently accompanied by nausea,
vomiting, and aura-related sound or other sensory
disturbances.1 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 In the U.S.,
between three and seven million Americans suffer from chronic
migraine, with at least 15 headache days per month with at least
eight days being migraine.4
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 a
Phase 2 study for chronic migraine) and AMG 301 (currently in a
Phase 1 study for migraine). 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 1/2a 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
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
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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,
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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.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(investors)
References
1 National Institute for
Neurological Disorders and Stroke. Headache: Hope Through Research.
http://www.ninds.nih.gov/disorders/headache/detail_headache.htm.
Accessed June 6, 2016.
2 World Health Organization. Headache disorders.
http://www.who.int/mediacentre/factsheets/fs277/en/. Updated
April 2016. Accessed June 6, 2016.
3 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(3): 355-63.
4 Vimont C. "Chronic Migraine Impacts Entire Family."
Practical Pain Management.
http://www.practicalpainmanagement.com/patient/conditions/headache/chronic-migraine-impacts-entire-family.
Updated November 19, 2015. Accessed
June 6, 2016.
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