THOUSAND OAKS, Calif.,
June 8, 2017 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced that it will present 19
scientific abstracts at the 59th Annual Scientific
Meeting of the American Headache Society (AHS) held June 8-11 in Boston. These include a new analysis from a
pivotal Phase 2 study highlighting the efficacy of erenumab in
patients with 15 or more headache days a month (chronic migraine)
and a recent history of acute migraine medication overuse.
Additionally, Amgen will present detailed clinical results and
patient-reported outcomes data from two Phase 3 studies of
erenumab, STRIVE and ARISE, for the prevention of migraine in
patients who experience between four and 14 headache days a month
(episodic migraine).
"Migraine is a disabling disease for many patients. It disrupts
daily living and the ability to function and participate in
activities with loved ones," said Sean E.
Harper, M.D., executive vice president of Research and
Development at Amgen. "The data from our clinical program
demonstrate that erenumab has a sustained effect in significantly
reducing the number of days people suffer from migraine each month.
Based on the benefit-risk profile seen in clinical studies,
erenumab is poised to become the first migraine-specific preventive
option blocking the calcitonin gene-related peptide, or CGRP,
receptor that could help get many patients back to doing the things
they love."
Excessive use of acute pain-relief medications is common among
people who suffer from migraine as they desperately try to control
the symptoms. Among the patients experiencing 15 or more headache
days a month in the erenumab Phase 2 study (n=667), 41 percent met
strict criteria for medication overuse. Compared to a 3.5-day
reduction in placebo, both dosages of erenumab reduced mean monthly
migraine days by 6.6 by the end of the study (both
p<0.001 versus placebo). Furthermore, days requiring
acute pain-relief medications were also significantly reduced in
both dosage arms (2.1-day reduction for placebo, compared to 5.4
days for erenumab 70 mg and 4.9 for erenumab 140 mg; both
p<0.001 versus placebo).
Detailed results from the positive six-month STRIVE study of
erenumab 70 mg and 140 mg, and the positive three-month ARISE study
of erenumab 70 mg will also be presented at the meeting. These data
include both primary and secondary endpoints, evaluating the
reduction in monthly migraine days and the percentage of patients
who responded to erenumab. Results from STRIVE have been submitted
for peer-reviewed publication.
The safety profile of erenumab was similar to placebo across all
treatment arms in the Phase 2 and Phase 3 studies. The most common
adverse events across the studies were upper respiratory tract
infection, injection site pain, nausea and nasopharyngitis.
Erenumab is a human monoclonal antibody specifically designed
for the prevention of migraine. Erenumab specifically inhibits the
CGRP receptor, believed to play a critical role in mediating the
incapacitating pain of migraine. Across the four
placebo-controlled Phase 2 and Phase 3 clinical studies, more than
2,600 patients have been exposed to erenumab.
These data support the first submissions in the United States (U.S.) and European Union
for a CGRP pathway inhibitor in migraine prevention. In addition,
an ongoing extension trial is underway evaluating people with
migraine for up to five years.
Amgen and Novartis will co-commercialize erenumab 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.
Amgen-sponsored abstracts at the 2017 Annual Scientific Meeting
of the AHS include:
Clinical Studies
- Early Onset of Efficacy in a Phase 2 Clinical Trial of
Erenumab in Patients with Chronic Migraine
Poster #PS24,
Saturday, June 10, 6:30 a.m. – 5 p.m.
ET
- A Multicenter, Open-label, Pharmacokinetic Drug Interaction
Study of Erenumab (AMG 334) and a Combined Oral Contraceptive in
Healthy Female Subjects (Ph1b DDI OC)
Poster #PS23,
Saturday, June 10, 6:30 a.m. – 5 p.m.
ET
- Chronic Migraine Treatment with Erenumab: Responder
Rates
Poster #PS33, Saturday, June
10, 6:30 a.m. – 5 p.m. ET
- Efficacy of Erenumab for the Treatment of Patients with
Chronic Migraine in Presence of Medication Overuse
Poster
#PS32, Saturday, June 10,
6:30 a.m. – 5
p.m. ET
- Phase 3, Randomized, Double-Blind, Placebo-Controlled Study
to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in
Migraine Prevention: Primary Results of the STRIVE
Trial
Platform Presentation #IOR04, Saturday, June 10, 8:30 – 8:40 a.m. ET
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled
Study to Evaluate the Efficacy and Safety of Erenumab in Migraine
Prevention: Primary Results of the ARISE Trial
Poster #PS21,
Saturday, June 10, 6:30 a.m. – 5 p.m.
ET
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study
to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in
Chronic Migraine Prevention
Platform Presentation #IOR07,
Saturday, June 10, 9 – 9:10 a.m. ET
- Patient Reported Outcomes in Chronic Migraine Patients
Receiving Placebo or Erenumab (AMG 334) in a Phase 2 Randomized,
Double-Blind Study
Poster #PS34, Saturday, June 10, 6:30
a.m. – 5 p.m. ET
- Patient-Reported Outcomes from the STRIVE Trial: A Phase 3,
Randomized, Double-Blind Study of Erenumab in Subjects with
Episodic Migraine
Poster #PS35 Saturday, June 10, 6:30
a.m. – 5 p.m. ET
- Patient-Reported Outcomes from the ARISE Trial: A Phase 3,
Randomized, Double-Blind Study of Erenumab in Subjects with
Episodic Migraine
Poster #PS22, Saturday, June 10, 6:30
a.m. – 5 p.m. ET
Global Health Economics
- The Impact of Physical Functioning in Adults with Chronic
and Episodic Migraine
Poster #PF47, Friday, June 9, 6:30
a.m. – 5 p.m. ET
- Patient Satisfaction with Current Prophylactic Migraine
Medications
Poster #PF02, Friday,
June 9, 6:30 a.m. –
5 p.m. ET
- Risk of Cerebrovascular Events in Migraine Patients Treated
with Prophylactic Medications
Poster #PF66, Friday, June 9, 6:30
a.m. – 5 p.m. ET
- Development and Psychometric Validation of the Migraine
Functional Impact Questionnaire (MFIQ): a New Instrument Measuring
the Impact of Migraine on Physical, Social, and Emotional
Functioning
Poster #PF40, Friday,
June 9, 6:30 a.m. –
5 p.m. ET
- How much change in headache-related disability is clinically
meaningful? Estimating minimally important difference (MID) or
change in MIDAS using data from the AMPP Study
Poster #PF52,
Friday, June 9, 6:30 a.m. – 5 p.m.
ET
- Improving Communications Between People with Migraine and
Healthcare Professionals for Optimized Migraine Management: A
Modified Delphi Approach to Designing a Migraine Tracker
App
Poster #PS61, Saturday, June
10, 6:30 a.m. – 5 p.m. ET
- Healthcare Costs and Utilization and Medication Treatment
Patterns Among Migraine Patients: A Retrospective
Analysis
Poster #PS58, Saturday, June
10, 6:30 a.m. – 5 p.m. ET
Center for Observational Research
- Risk of Cardiovascular Events in Migraine Patients Treated
with Prophylactic Medications
Poster #PF03, Friday, June 9, 6:30
a.m. – 5 p.m. ET
Late-Breaking Research
- Effect of Anti-CGRP Receptor Antibody AA58 on CGRP Receptor
Internalization and Trafficking
Late-Breaking Poster
#PF85LB, Friday, June 9, 6:30 a.m. – 5
p.m. ET
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
nine 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 Phase 3 Studies
STRIVE (STudy to
evaluate the efficacy and safety of erenumab in migRaIne
preVEntion, 20120296) is a global Phase 3, multicenter, randomized
six-month, double-blind, placebo-controlled study evaluating the
safety and efficacy of erenumab in episodic migraine prevention. In
the study, 955 patients were randomized to receive once-monthly
subcutaneous placebo or erenumab (70 mg or 140 mg) in a 1:1:1
ratio. Patients enrolled in STRIVE were experiencing an average of
8.3 migraine days per month at baseline. The primary endpoint was
change from baseline in mean monthly migraine days over the last
three months of the double-blind treatment phase of the study
(months 4, 5, 6). Secondary study endpoints included reduction of
at least 50 percent from baseline in mean monthly migraine days,
change from baseline in mean monthly acute migraine-specific
medication days, and reductions from baseline in both mean impact
on everyday activities domain and mean physical impairment domain
scores on the Migraine Physical Function Impact Diary (MPFID).
ARISE (A Phase 3, RandomIzed, double-blind, placebo-controlled
Study to Evaluate the efficacy and safety of erenumab in migraine
prevention, 20120297) is a global Phase 3, multicenter, randomized,
three-month, double-blind, placebo-controlled study evaluating the
safety and efficacy of erenumab in episodic migraine prevention. In
the study, 577 patients were randomized to receive once-monthly
subcutaneous placebo or erenumab (70 mg) in a 1:1 ratio. Study
participants who completed the double-blinded portion had the
option to continue in a long-term safety extension. Patients
enrolled in ARISE were experiencing an average 8.3 migraine days
each month at baseline. The primary endpoint was change from
baseline in monthly migraine days from baseline to the last four
weeks of the three-month treatment phase (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 and change from baseline in monthly acute migraine-specific
medication treatment days. The MPFID assessed two other secondary
endpoints.
About Erenumab
Erenumab is a human monoclonal antibody
specifically designed for the prevention of migraine. Erenumab
specifically inhibits the receptor of the calcitonin gene-related
peptide (CGRP) which is thought to play a causal role in migraine
pathophysiology. Erenumab has been studied in several large global,
randomized, double-blind, placebo-controlled trials to assess its
safety and efficacy in migraine prevention.
About Migraine
Migraine is a distinct neurological
disease.1 People with migraine lose a substantial
portion of their lives to this illness, experiencing significant
physical impairment, frequently accompanied by head pain, nausea,
vomiting and meaningful disruption of daily activities.1
The World Health Organization ranks migraine as one of the most
debilitating illnesses.2 For the approximately 10
million Americans whose migraine frequency or severity impacts
daily activities, preventive medications may be an
option.3 Approximately 3.5 million of these patients are
currently on a preventive therapy, but up to 80 percent discontinue
these within one year.3,4 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 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 (Biologics License Application submitted to U.S. FDA in
May 2017) and AMG 301 (currently in
Phase 1 development). In April 2017,
the collaboration was expanded to include co-commercialization of
erenumab in the U.S. For the migraine program, Amgen retains
exclusive rights in Japan, and
Novartis has exclusive rights in Europe, Canada and rest of world. Also, the companies
are partnering in the development and commercialization of a
beta-secretase 1 (BACE) inhibitor program in AD. The oral therapy
CNP520 (currently in Phase 3 for AD) 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
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forward-looking statements that are based on the current
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statements of historical fact, are statements that could be deemed
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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. Our results
may be affected by our ability to successfully market both new and
existing products domestically and internationally, clinical and
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Furthermore, our research, testing, pricing, marketing and other
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Discovery or identification of new product candidates cannot be
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Such product candidates are not approved by the U.S. Food and Drug
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CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(investors)
References
1Lipton RB, et al. Migraine prevalence, disease
burden, and the need for preventative therapy. Neurology. 2007;
68(5):343-9.
2Headache disorders - Fact sheets. World Health
Organization. http://www.who.int/mediacentre/factsheets/fs277/en/.
Accessed March 3, 2017.
3Marketscan data on file. March
31, 2017. Ref Type: Data File
4Hepp Z et al. Adherence to oral migraine-preventive
medications among patients with chronic migraine. Cephalalgia.
2015; 35(6):478-88.
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