THOUSAND OAKS, Calif.,
Jan. 22, 2018 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced positive results from
the Phase 3b LIBERTY study assessing
the efficacy and safety of Aimovig™ (erenumab) 140 mg in patients
with episodic migraine who had experienced two to four previous
preventive treatment failures, due to lack of efficacy or
intolerable side effects. The study met its primary endpoint, with
significantly more patients taking Aimovig experiencing at least a
50 percent reduction from baseline in their monthly migraine days
as compared to placebo. LIBERTY also met all secondary endpoints,
including reduction of monthly migraine days, reduction in days
needing acute (rescue) medication, improvement in scores on the
Migraine Physical Function Impact Diary (MPFID) tool, and 75
percent and 100 percent responder rates (number of patients
experiencing at least a 75 percent or 100 percent reduction in
monthly migraine days compared to placebo). The safety data are
consistent with previous studies of Aimovig to date. Full data will
be presented at an upcoming scientific meeting.
Aimovig is the only investigational fully human monoclonal
antibody, designed to selectively block the calcitonin gene-related
peptide (CGRP) receptor, which plays a critical role in migraine
activation. These results are the first positive placebo-controlled
data ever reported in an episodic patient population consisting
entirely of those who have tried and failed two to four preventive
medications due to lack of efficacy or intolerable side
effects.
"We've purposely designed a clinical program for Aimovig that
examined a broad spectrum of migraine patients, ranging from those
who have never tried a preventive treatment to patients who have
tried and failed such treatments," said Sean E. Harper, M.D., executive vice president
of Research and Development at Amgen. "These data in patients with
multiple treatment failures, who are not only considered difficult
to treat but also have few options available, add to the consistent
body of evidence for Aimovig. We look forward to working with
regulators to bring the first preventive option specifically
developed for migraine to patients worldwide."
The safety, efficacy and tolerability of Aimovig have been
assessed in more than 3,000 patients, including an ongoing
open-label extension of up to five years in duration. Aimovig was
the first investigational therapy targeting the CGRP pathway to
receive U.S. Food and Drug Administration (FDA) and European
Medicines Agency regulatory filing acceptance. The FDA has set a
Prescription Drug User Fee Act (PDUFA) target action date of
May 17, 2018. If approved, it will be
administered once-monthly using a self-injection device. If
approved, Novartis and Amgen will co-commercialize Aimovig in the
U.S. Amgen has exclusive commercialization rights to the drug in
Japan and Novartis has exclusive
rights to commercialize in rest of world.
About LIBERTY
LIBERTY (NCT03096834) is a Phase
3b, multicenter, randomized 12-week,
double-blind, placebo-controlled study evaluating the safety and
efficacy of Aimovig in patients with episodic migraine (defined in
the trial as four to 14 migraine days per month at baseline) who
have failed up to four prior preventive treatments for migraine. In
the study, 246 participants with episodic migraine who had two to
four previous treatment failures were randomized to receive Aimovig
140 mg or placebo during the 12-week double-blind treatment phase.
The primary endpoint was the percentage of patients with at least a
50 percent reduction of monthly migraine days from baseline over
the last four weeks of the double-blind treatment phase of the
study (weeks 9-12).1 The study includes an ongoing
52-week open-label extension study.
Secondary endpoints assessed during the same time period
included: change from baseline in monthly migraine days, change
from baseline in the number of monthly acute migraine-specific
medication treatment days, and change from baseline in the MPFID
physical impairment and impact on everyday activities domain
scores. The MPFID is a scale developed to measure these two
domains. The scale has been validated in line with FDA Patient
Reported Outcomes Guidance.2 Percentages of patients
with a 75 percent response rate and 100 percent response rate to
erenumab were also assessed as secondary endpoints.
About Aimovig™ (erenumab)
Aimovig is the only
treatment specifically designed to prevent migraine by blocking the
CGRP receptor, which is associated with migraine activation.
Aimovig has been studied in several large global, randomized,
double-blind, placebo-controlled studies to assess its safety and
efficacy in migraine prevention. The safety, efficacy and
tolerability of Aimovig has been assessed in more than 3,000
patients, including an ongoing open-label extension of up to five
years in duration. Regulatory submissions have been filed in
the U.S. and Europe.
About Migraine
People with frequent migraine may lose
more than half their life to migraine days.3 Migraine
robs individuals of time with their families, productivity at home
and at work, and their livelihoods. Migraine sufferers endure
debilitating pain, physical impairment, and live in constant dread
of the next attack – all of which is compounded by a widespread
misperception of the disease.4 The World Health
Organization ranks migraine as one of the most debilitating
illnesses.4 For the approximately 10 million Americans
whose migraine frequency or severity impacts daily activities,
preventive medications may be an option.5 Approximately
3.5 million of these patients are currently on a preventive
therapy, but up to 80 percent discontinue these within one
year.6,7 Migraine is associated with personal and
societal burdens of pain, disability, and financial cost, and it
remains under-recognized and under-treated.
About Amgen and Novartis Neuroscience Collaboration
In
August 2015, Amgen entered into a
global collaboration with Novartis to develop and commercialize
pioneering treatments in the field of migraine and Alzheimer's
disease. The collaboration focuses on investigational Amgen drugs
in the migraine field, including Aimovig (Biologics License
Application submitted to FDA in May
2017) and AMG 301 (currently in Phase 2 development). In
April 2017, the collaboration was
expanded to include co-commercialization of Aimovig in the U.S. For
the migraine programs, Amgen retains exclusive commercialization
rights in the U.S. (other than for Aimovig as described as above)
and Japan, and Novartis has
exclusive commercialization rights in Europe, Canada and rest of world. Also, the companies
are collaborating in the development and commercialization of a
beta-secretase 1 (BACE) inhibitor program in Alzheimer's disease.
The oral therapy CNP520 (currently in Phase 3 for Alzheimer's
disease) is 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 current reports on 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, including our devices, 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
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may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
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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, including Puerto Rico, 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. Certain of our
distributors, customers and payers have substantial purchasing
leverage in their dealings with us. 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.
*The trade name Aimovig™ is provisionally approved for use by
the U.S. Food and Drug Administration.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(investors)
References
1 ClinicalTrials.gov A Study
Evaluating the Effectiveness of AMG 334 Injection in Preventing
Migraines in Adults Having Failed Other Therapies (LIBERTY).
https://clinicaltrials.gov/ct2/show/NCT03096834. Accessed
January 2018.
2 Kawata AK et al. Psychometric Evaluation of a Novel
Instrument Assessing the Impact of Migraine on Physical
Functioning: The Migraine Physical Function Impact Diary. Headache.
2017; 57(9) 1385-1398.
3 Lipton RB, et al. Migraine prevalence, disease burden,
and the need for preventative therapy. Neurology. 2007;
68(5):343-9.
4 Stewart WF, Ricci JA, Chee E, Morganstein D, Lipton R.
Lost productive time and cost due to common pain conditions in the
US workforce. JAMA. 2003;290:2443-54
5 Headache disorders - Fact sheets. World Health
Organization. http://www.who.int/mediacentre/factsheets/fs277/en/.
Accessed September 17, 2017.
6 Marketscan data on file. September 17, 2017. Ref Type: Data File
7 Hepp Z et al. Adherence to oral migraine-preventive
medications among patients with chronic migraine. Cephalalgia.
2015; 35(6):478-88.
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