THOUSAND OAKS, Calif.,
June 19, 2015 /PRNewswire/ -- Amgen
(NASDAQ: AMGN) today announced positive interim results from its
open-label extension of the global Phase 2, double-blind,
placebo-controlled study evaluating the safety and efficacy of AMG
334 for the prevention of episodic migraine. Patients who entered
the open-label phase received AMG 334 70 mg monthly and experienced
a sustained reduction in monthly migraine days at week 52. The data
were presented at the 57th Annual Scientific Meeting of the
American Headache Society (AHS) on June 19,
2015, in Washington,
D.C.
At one year, patients receiving AMG 334 70 mg experienced an
average of a -4.9-day reduction from a baseline of 8.7 mean monthly
migraine days, regardless of treatment received during the blinded
phase. The 50 percent responder rate (greater than 50 percent
reduction in monthly migraine days) was 62 percent at 52 weeks.
Additional responder rates were reported for the first time: at 52
weeks the 75 percent responder rate was 38 percent and the 100
percent responder rate was 19 percent.
"These long-term data further demonstrate that AMG 334 provided
meaningful benefit to these patients with fewer migraine days and
more days with the ability to participate in work and social
activities each month," said Sean E.
Harper, M.D., executive vice president of Research and
Development at Amgen. "The sustained safety and efficacy shown in
this interim analysis adds to the growing body of evidence that
reinforces the potential of AMG 334 for patients with this
debilitating condition. We look forward to advancing the program to
help fill an unmet need in migraine prevention."
The open-label portion of the Phase 2 study included 383
patients. All patients received AMG 334 70 mg starting at week 12
for up to 256 weeks. Safety and tolerability were evaluated monthly
and this interim analysis includes data up to week 52. Additional
efficacy endpoints included the change in monthly migraine-specific
medication use days and patient-reported outcomes using the
Migraine Disability Assessment (MIDAS) questionnaire.
Patients reported a nearly 50 percent reduction of monthly
migraine-specific medication use days of -2 at 52 weeks, from a
baseline of 4.3 days per month. In addition to clinical measures,
patients self-reported the impact of headache and migraine on their
daily activities. At one year, using the MIDAS tool, patients
reported an improvement of approximately 12 days over the previous
three months in their ability to function in work, home and social
situations. According to the Migraine Research Foundation, migraine
costs American employers more than $13
billion each year as a result of 113 million lost work
days.
The safety and tolerability profile during the open-label phase
was similar to that observed in the blinded phase of the study. The
most commonly reported adverse events included fatigue, influenza,
nasopharyngitis, arthralgia and back pain. No Grade 4 or 5 adverse
events were reported. Serious adverse events were reported in 13
patients, one of which was deemed treatment-related. Less than 5
percent of patients discontinued the study during the open-label
phase due to adverse events.
About Migraine
Migraine has been declared one of the
top 10 most disabling conditions in the world, with more than 10
percent of the worldwide population suffering from the
condition.1 More complex than just a headache, migraines
involve incapacitating head pain and physical impairment,
frequently accompanied by nausea, vomiting, and aura-related sound
or other sensory disturbances.2 Migraine poses a
significant burden to society, costing American employers more than
$13 billion each year as a result of
113 million lost work days due to migraine.3 Migraine
also has a tremendous impact on patients' everyday lives, including
work productivity and social interactions.3,4
More than half of people living with migraine will go
undiagnosed.5
About AMG 334
AMG 334 is a fully human monoclonal
antibody under investigation for the prevention of migraine. AMG
334 targets the calcitonin gene-related peptide (CGRP) receptor,
which is believed to transmit signals that can cause incapacitating
pain.
AMG 334 is currently under evaluation in several large global,
randomized, double-blind, placebo-controlled studies to evaluate
its safety and efficacy in migraine prevention.
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 biologics manufacturing 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 the world's
largest independent biotechnology company, 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 Inc. and its subsidiaries (Amgen,
we or us) and are subject to a number of risks, uncertainties and
assumptions that could cause actual results to differ materially
from those described. 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 Inc., including Amgen Inc.'s most
recent annual report on Form 10-K and any subsequent periodic
reports on Form 10-Q and Form 8-K. Please refer to Amgen Inc.'s
most recent Forms 10-K, 10-Q and 8-K for additional information on
the uncertainties and risk factors related to our business. Unless
otherwise noted, we are providing this information as of
June 19, 2015, and expressly disclaim
any duty to update information contained in this news release.
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
and our partners to complete clinical trials and obtain regulatory
approval for product marketing has in the past varied and we expect
similar variability in the future. 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 business may be
impacted by government investigations, litigation and product
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of our current products and product candidate development.
In addition, sales of our products (including products of our
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affected by regulatory, clinical and guideline developments and
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pharmaceutical pricing and reimbursement. Government and others'
regulations and reimbursement policies may affect the development,
usage and pricing of our products. In addition, we compete with
other companies with respect to some of our marketed products as
well as for the discovery and development of new products. We
believe that some of our newer products, product candidates or new
indications for existing products, may face competition when and as
they are approved and marketed. Our products may compete against
products that have lower prices, established reimbursement,
superior performance, are easier to administer, or that are
otherwise competitive with our products. In addition, while we and
our partners routinely obtain patents for our and their products
and technology, the protection of our products offered by patents
and patent applications may be challenged, invalidated or
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no guarantee of our or our partners' ability to obtain or maintain
patent protection for our products or product candidates. We cannot
guarantee that we will be able to produce commercially successful
products or maintain the commercial success of our existing
products. Our stock price may be affected by actual or perceived
market opportunity, competitive position, and success or failure of
our products or product candidates. Further, 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
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may experience difficulties, delays or unexpected costs and not
achieve anticipated benefits and savings from our restructuring
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ability of our Board of Directors to declare a dividend or our
ability to pay a dividend or repurchase 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)
Arvind Sood, 805-447-1060
(investors)
1 Vos 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.
2 National Institute for Neurological Disorders and
Stroke. Headache: Hope Through Research.
http://www.ninds.nih.gov/disorders/headache/detail_headache.htm.
Accessed June 4, 2015.
3 Migraine Research Foundation. Migraine Fact Sheet.
2015. Available:
http://www.migraineresearchfoundation.org/fact-sheet.html. Accessed
June 4, 2015.
4 Scher Al, Stewart WF, Ricci JA, Lipton RB. Factors
associated with the onset and remission of chronic daily headache
in a population-based study. Pain. 2003 Nov:
106(102:81-9).
5 National Headache Foundation. Migraine. Oct 2007. Available:
http://www.headaches.org/2007/10/25/migraine/. Accessed
June 4, 2015.
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