THOUSAND OAKS, Calif.,
May 15, 2015 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced the first results from its global
Phase 2, double-blind, placebo-controlled study evaluating the
efficacy and safety of AMG 334 for the prevention of episodic
migraine. The study met its primary endpoint of reducing monthly
mean migraine days compared with placebo. The data were presented
at the 17th Congress of the International Headache
Society (IHC 2015) in Valencia,
Spain.
AMG 334 is a fully human monoclonal antibody under investigation
for the prevention of migraine by inhibiting the calcitonin
gene-related peptide (CGRP) receptor that is believed to transmit
signals that can cause incapacitating pain.
In the trial, 483 patients were randomized to subcutaneous
monthly placebo or AMG 334 (7 mg, 21 mg or 70 mg) in a 3:2:2:2
ratio, respectively. Patients had a mean baseline of 8.7 migraine
days per month. The primary endpoint was the change from baseline
in monthly migraine days at week 12. Patients randomized to the 70
mg dose group observed a statistically significant 3.4-day
reduction in monthly migraine days compared with 2.28 days observed
in the placebo group (p=0.021).
"Migraine is a complicated, underdiagnosed neurological
condition that has significant impact on the everyday activities of
those who live with it, and for the millions of people around the
world who are affected by this disease, significant unmet
therapeutic need persists," said Sean E.
Harper, M.D., executive vice president, Research and
Development at Amgen. "We are encouraged by these Phase 2 data,
which further validate AMG 334 as a potential preventive treatment
for episodic migraine."
Secondary study endpoints included a 50 percent responder rate,
monthly migraine attacks, and safety and tolerability. Key
exploratory endpoints included change in monthly headache days and
change in monthly acute migraine-specific medication use days. AMG
334 demonstrated a statistically significant increase in the 50
percent responder rate compared with placebo (47 percent vs. 30
percent, respectively). Furthermore, reductions in monthly
headache days (-3.54 vs. -2.39) and monthly migraine-specific
medication use days (-1.64 vs. -.69) were also statistically
significant in patients taking the 70 mg AMG 334 dose compared with
placebo, respectively.
The dose tolerability profile of AMG 334 was similar to placebo
across all dosing groups. The most commonly reported adverse events
included fatigue, influenza, nasopharyngitis, arthralgia and back
pain. No Grade 4 or 5 adverse events were reported.
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 has a tremendous impact on
patients' everyday lives, including work productivity and social
interactions.3,4 Approximately 50 percent 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 inhibits the CGRP receptor,
rather than CGRP itself, which is believed to transmit signals that
can cause incapacitating pain.
AMG 334 is currently under investigation 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 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 Inc. and its
subsidiaries (Amgen, we or us) and are subject to a number of
risks, uncertainties and assumptions that could cause actual
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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
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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 May 15, 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
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and our partners to complete clinical trials and obtain regulatory
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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 April 20, 2015.
3 Migraine Research Foundation. Migraine Fact Sheet.
http://www.migraineresearchfoundation.org/fact-sheet.html. Accessed
April 17, 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. Facts About Migraine.
Available:
http://www.headaches.org/press/NHF_Press_Kits/Press_Kits_-_Facts_About_Migraine.
Accessed March 27, 2015.
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