THOUSAND OAKS, Calif.,
May 11, 2015 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced it will be presenting
data for its calcitonin gene-related peptide (CGRP) receptor
inhibitor AMG 334 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
receptor of CGRP, which has long been understood to play a role in
the migraine pain pathway.
"Migraine is a debilitating condition that exerts a tremendous
impact on patients' everyday lives. While current therapies have
the potential to reduce the number of headache days a migraneur
might experience each month, many patients who start treatment
discontinue within a year due to lack of efficacy or side effects,"
said Sean E. Harper, M.D., executive
vice president, Research and Development at Amgen. "We are excited
to add these positive results to our growing body of data across
our global AMG 334 clinical program and are committed to evaluating
this potential treatment option for the prevention of migraine to
help address a significant unmet need."
Data to be presented include results from a Phase 2 randomized,
double-blind, placebo-controlled, dose-ranging study evaluating AMG
334 for the prevention of episodic migraine, as well as results
from two Phase 1 studies evaluating dosing and pharmacokinetic-
pharmacodynamic modeling in capsaicin-induced increase in dermal
blood flow.
SELECTED ABSTRACTS OF INTEREST
AMG 334 Oral Presentations
- Results of a randomized, double-blind, placebo-controlled,
Phase 2 study to evaluate the efficacy and safety of AMG 334 for
the prevention of episodic migraine. Abstract IHC15-0284, Oral
Presentation, Friday, May 15,
10:00 a.m. to
11:00 a.m. CEDT
AMG 334 Poster Presentations
- Phase 1, randomized, double-blind, placebo-controlled,
single-dose and multiple-dose studies of AMG 334 in healthy
subjects and migraine patients. Abstract IHC15-0266. Poster
available to view from Thursday, May
14 at 12:30 p.m. CEDT until
Friday, May 15 at 8:30 p.m. CEDT
- Pharmacokinetic/pharmacodynamics modeling of monoclonal
antibody AMG 334 to characterize concentration relationship with
capsaicin-induced increase in dermal blood flow in healthy subjects
and migraine patients. Abstract IHC15-0285; Lunch Session I:
Friday, May 15, 1:00 p.m. CEDT and poster available to view from
Thursday, May 14 at 12:30 p.m. CEDT until Friday, May 15 at 8:30
p.m. CEDT
Additional Abstracts of Interest
- Understanding reasons for patient non-adherence to
prophylactic migraine medications. Abstract IHC15-0451. Poster
available to view from Thursday, May
14 at 12:30 p.m. CEDT until
Friday, May 15 at 8:30 p.m. CEDT
- Treatment patterns for migraine patients receiving
prophylaxis. Abstract IHC15-0273. Poster available to view from
Thursday, May 14 at 12:30 p.m. CEDT until Friday, May 15 at 8:30
p.m. CEDT
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 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 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
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 May 11, 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
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could identify safety, side effects or manufacturing problems with
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In addition, sales of our products (including products of our
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well as for the discovery and development of new products. We
believe that some of our newer products, product candidates or new
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our partners routinely obtain patents for our and their products
and technology, the protection of our products offered by patents
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products or maintain the commercial success of our existing
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market opportunity, competitive position, and success or failure of
our products or product candidates. Further, the discovery of
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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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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)
Cuyler Mayer, 805-447-6332
(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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SOURCE Amgen