THOUSAND OAKS, Calif.,
Dec. 7, 2020 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced a partnership with Karamo Brown, Emmy-nominated host from Netflix's
hit show "Queer Eye," to support and empower people living with
migraine. Karamo, who is known for helping people open up about
themselves, is discussing his own struggles with migraine for the
first time to help spread knowledge and acceptance. The Know
Migraine Mission is a national effort by the companies behind
Aimovig® (erenumab-aooe) to challenge public
misconceptions, start new conversations and make the world a more
migraine-friendly place. As part of the initiative, Karamo, who is
not an Aimovig® patient but has dealt with migraine for
years, will share his thoughts with people personally affected by
migraine along with their friends, families and coworkers to help
increase understanding of the disease.
"We've all been feeling the stress of this year, and it's
compounded if you live with migraine like me. However, some people
don't realize how challenging this disease can be, which is why I'm
excited to lend my voice to the Know Migraine Mission," said
Karamo. "For people with migraine, talking about it can help make a
real difference in their lives. Those conversations are important,
even though they might look different today – so, whether it's a
social-distanced lunch date with a friend or a video call with a
doctor, it's important to take control where possible."
Migraine is a complex neurological disease that impacts millions
of people in the U.S.2-5 Despite its prevalence and
severity, migraine is often misunderstood and dismissed as being
"just a headache."6 Research shows people may often feel
stigmatized for missing time with friends, family and co-workers
because of their migraine.2,6
Karamo has struggled with migraine since he was in high school.
The disease has impacted many parts of his life, including his
ability to spend time with his two sons and other family and
friends. As part of this partnership, Karamo is answering questions
and sharing his thoughts with others who are living with this
disease. On KnowMigraineMission.com and social media,
including the Aimovig Facebook and Instagram pages,
Karamo will address how others can start new conversations to help
reduce the stigma around migraine.6
Aimovig, co-marketed in the U.S. by Amgen and Novartis, is the
first Food and Drug Administration (FDA)-approved treatment
indicated to prevent migraine in adults by targeting the calcitonin
gene-related peptide (CGRP) receptor.7 Clinical study
results have established the efficacy and safety profile of Aimovig
across a spectrum of people living with both episodic and chronic
migraine.8,9
"Aimovig is proven to reduce monthly migraine days and for some,
can cut the number of monthly migraine days in half or more,
allowing patients to be there more in their everyday
lives," said Darryl Sleep,
M.D., senior vice president, Global Medical, and chief medical
officer at Amgen. "But while treatment has evolved, progress
still needs to be made to change the conversation around migraine
and better support people living with this debilitating
disease. Through the Know Migraine Mission, we want to educate
the broader community about the impact of migraine and empower
people to speak up about their disease and seek treatment options
that may be appropriate for them."
To learn more about Karamo's story and for additional
information and resources,
visit www.KnowMigraineMission.com and follow Aimovig on
Facebook and Instagram.
About the Know Migraine Mission
The Know Migraine Mission is a national effort by Amgen and
Novartis to challenge public misconceptions, start new
conversations and make the world a more migraine-friendly place.
The way migraine can be treated has changed,7 but the
way people with migraine are treated still has a long way to go.
Amgen and Novartis believe the more vocal and visible people with
migraine are, the more others will recognize the debilitating
effects of this disease.5
About Aimovig®
(erenumab-aooe)
Aimovig, co-marketed in the U.S. by Amgen and Novartis, is the
first FDA-approved migraine preventive treatment that targets the
calcitonin gene-related peptide (CGRP) receptor, which is
associated with migraine.7,11 Aimovig has been studied
in several large, global, randomized, double-blind,
placebo-controlled studies to assess its efficacy and safety in
migraine prevention.9,10 Aimovig is self-administered
once monthly via the easy-to-use SureClick®
autoinjector, without a required loading dose.7,12 More
than 3,000 patients participated in registrational trials of
Aimovig across four placebo-controlled Phase 2 and Phase 3 clinical
studies and their open-label extensions.8,9,10,13,14
Aimovig is also being evaluated through CATALYST, a
comprehensive evidence generation program initiated by Amgen and
Novartis that includes over 7,500 patients across ongoing clinical
trials and a robust assessment of real-world evidence. Spanning
over 39 countries globally, CATALYST clinical trials will explore
the role of Aimovig in comparative studies, assessing impact on
novel migraine outcomes, understanding predictive biomarkers and
investigating Aimovig's use in additional study populations. To
date, more than 480,000 patients worldwide have been prescribed
Aimovig for the preventive treatment of migraine in
adults.15
AIMOVIG INDICATION
Aimovig® (erenumab-aooe) is indicated for the preventive
treatment of migraine in adults.
IMPORTANT SAFETY INFORMATION
Contraindication: Aimovig® is contraindicated in
patients with serious hypersensitivity to erenumab-aooe or to any
of the excipients. Reactions have included anaphylaxis and
angioedema.
Hypersensitivity Reactions: Hypersensitivity reactions,
including rash, angioedema, and anaphylaxis, have been reported
with Aimovig® in post marketing experience. Most
reactions were not serious and occurred within hours of
administration, although some occurred more than one week after
administration. If a serious or severe reaction occurs, discontinue
Aimovig® and initiate appropriate therapy.
Constipation with Serious Complications: Constipation
with serious complications has been reported following the use of
Aimovig® in the postmarketing setting. There were cases
that required hospitalization, including cases where surgery was
necessary. The onset of constipation was reported after the first
dose in a majority of these cases, but patients also reported later
on in treatment. Aimovig® was discontinued in most
reported cases. Constipation was one of the most common (up to 3%)
adverse reactions reported in clinical studies.
Monitor patients treated with Aimovig® for severe
constipation and manage as clinically appropriate. Concurrent use
of medications associated with decreased gastrointestinal motility
may increase the risk for more severe constipation and the
potential for constipation-related complications.
Hypertension: Development of hypertension and
worsening of pre-existing hypertension have been reported following
the use of Aimovig® in the postmarketing setting. Many
of the patients had pre-existing hypertension or risk factors for
hypertension. There were cases requiring pharmacological treatment
and, in some cases, hospitalization. Hypertension may occur at any
time during treatment but was most frequently reported within seven
days of dose administration. In the majority of the cases, the
onset or worsening of hypertension was reported after the first
dose. Aimovig® was discontinued in many of the reported
cases.
Monitor patients treated with Aimovig® for new-onset
hypertension, or worsening of pre-existing hypertension, and
consider whether discontinuation of Aimovig® is
warranted if evaluation fails to establish an alternative
etiology.
Adverse Reactions: The most common adverse reactions in
clinical studies (≥ 3% of Aimovig®-treated patients and
more often than placebo) were injection site reactions and
constipation.
Please see Aimovig® full Prescribing
Information.
About Migraine
People with frequent migraine attacks may lose more than half their
life to migraine.16,17 One attack could last up to three
days.16 They 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.5,6 The 2017 Global Burden of Disease Study
ranks migraine among the top 10 causes of years lived with
disability worldwide.18 Migraine is associated with
personal and societal burdens of pain, disability and financial
cost, and it remains under-recognized and
under-treated.2,19
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. The collaboration
focuses on investigational Amgen drugs in the migraine field,
including Aimovig (approved by the FDA in May 2018 for the preventive treatment of migraine
in adults).7 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 above) and Japan, and Novartis has exclusive
commercialization rights in Europe, Canada and rest of world. At the center of the
Amgen and Novartis neuroscience collaboration is the shared mission
to fight migraine and the stereotypes and misperceptions
surrounding this debilitating disease.
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.
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 any statements on the outcome, benefits and synergies of
collaborations, or potential collaborations, with any other
company, including BeiGene, Ltd. or any collaboration or potential
collaboration in pursuit of therapeutic antibodies against COVID-19
(including statements regarding such collaboration's, or our own,
ability to discover and develop fully-human neutralizing antibodies
targeting SARS-CoV-2 or antibodies against targets other than the
SARS-CoV-2 receptor binding domain, and/or to produce any such
antibodies to potentially prevent or treat COVID-19), or the
Otezla® (apremilast) acquisition (including anticipated
Otezla sales growth and the timing of non-GAAP EPS accretion), as
well as 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, effects of pandemics or
other widespread health problems such as the ongoing COVID-19
pandemic on our business, outcomes, progress, or effects relating
to studies of Otezla as a potential treatment for COVID-19, 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
governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
healthcare cost containment. Furthermore, our research, testing,
pricing, marketing and other operations are subject to extensive
regulation by domestic and foreign government regulatory
authorities. Our business may be impacted by government
investigations, litigation and product liability claims. In
addition, our business may be impacted by the adoption of new tax
legislation or exposure to additional tax liabilities. If we fail
to meet the compliance obligations in the corporate integrity
agreement between us and the U.S. government, we could become
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 in 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. An outbreak of disease or similar public
health threat, such as COVID-19, and the public and governmental
effort to mitigate against the spread of such disease, could have a
significant adverse effect on the supply of materials for our
manufacturing activities, the distribution of our products, the
commercialization of our product candidates, and our clinical trial
operations, and any such events may have a material adverse effect
on our product development, product sales, business and results of
operations. We rely on collaborations with third parties for the
development of some of our product candidates and for the
commercialization and sales of some of our commercial products. 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 collaborate
with or acquire other companies, products or technology, and to
integrate the operations of companies or to support the products or
technology we have acquired, may not be successful. A breakdown,
cyberattack or information security breach could compromise the
confidentiality, integrity and availability of our systems and our
data. 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. We may
not be able to access the capital and credit markets on terms that
are favorable to us, or at all.
Any scientific information discussed in this news release
relating to new indications for our products is preliminary and
investigative and is not part of the labeling approved by the U.S.
Food and Drug Administration for the products. The products are not
approved for the investigational use(s) discussed in this news
release, and no conclusions can or should be drawn regarding the
safety or effectiveness of the products for
these uses.
References
- Al-Hashel and Ismail. Impact of coronavirus disease 2019
(COVID-19) pandemic on patients with migraine: a web-based survey
study. The Journal of Headache and Pain. (2020) 21:115.
- Lipton R, Bigal ME, Diamond M, et al. Migraine prevalence,
disease burden, and the need for preventive therapy.
Neurology. 2007;68(5)343-349.
- US Census Bureau. Age and Sex 2014-2018 American Community
Survey 5-Year Estimate.
https://data.census.gov/cedsci/table?q=united%
20states&tid=ACSDP5Y2018.DP05&hidePreview=true. Accessed
October 21, 2020.
- Buse DC, Manack AN, Fanning KM, et al. Chronic migraine
prevalence, disability, and sociodemographic factors: results from
the American Migraine Prevalence and Prevention Study.
Headache. 2012;52(10):1456-1470.
- Russo AF. Annu Rev Pharmacol Toxicol.
2015;55:533-552.
- Rutberg S, Ohrling K. Migraine – more than a headache: Women's
experiences of living with migraine. Disabil Rehabil.
2012;34(4):329-336.
- Aimovig® (erenumab-aooe) prescribing information,
Amgen, April 2020.
- Ashina M, Goadsby P, Reuter U, et al. Sustained efficacy and
long-term safety of erenumab inpatients with episodic migraine:
results of a 5-year, open-label extension study. Presented at The
18th Migraine Trust Virtual Symposium; October 3-9, 2020; London, U.K.
- Tepper S, Ashina M, Reuter U, et al. Safety and efficacy of
erenumab for preventive treatment of chronic migraine: a
randomised, double-blind, placebo-controlled phase 2 trial.
Lancet Neurol. 2017;16(6):425-434.
doi:10.1016/S1474-4422(17)30083-2.
- Olesen J, Diener HS, Husstedt I, et al. Calcitonin gene-related
peptide receptor antagonist BIBN 4096 BS for the acute treatment of
migraine. N Engl J Med. 2004;350(11):1104-1110.
- Sun H, Dodick DW, Silberstein S, et al. Safety and efficacy of
AMG 334 for prevention of episodic migraine: a randomised,
double-blind, placebo-controlled, phase 2 trial. Lancet
Neurol. 2016;15(4):382-390.
doi:10.1016/S1474-4422(16)00019-3.
- Data on File. Amgen. May
2019.
- Reuter U, Goadsby PJ, Lanteri-Minet M, et al. Sustained
Efficacy and Safety of Erenumab in Episodic Migraine Patients
Failing 2–4 Prior Preventive Treatments: 2-year Interim Results of
the LIBERTY Open-Label Extension Study. Presented at the 18th
Migraine Trust Virtual Symposium; October
3-9, 2020; London,
U.K.
- Wang S-J, Roxas Jr, A, Saravia B, et al. Efficacy and Safety of
Erenumab in Patients with Episodic Migraine from the EMPOWER Study.
Presented at the 18th Migraine Trust Virtual Symposium;
October 3-9, 2020; London, U.K.
- Data on File. Novartis. October
2020.
- Headache Classification Committee of the International Headache
Society (IHS). The International Classification of Headache
Disorders, 3rd edition. Cephalalgia. 2018;38(1):1-211.
- Lipton R, Stewart WF, Diamond S, et al. Prevalence and burden
of migraine in the United States:
data from the American Migraine Study II. Headache.
2001;41(7):1-211.
- GBD 2017 Disease and Injury Incidence and Prevalence
Collaborators. Global, regional, and national incidence,
prevalence, and years lived with disability for 354 diseases and
injuries for 195 countries, 1990–2017: a systematic analysis for
the Global Burden of Disease Study 2017. Lancet.
2018;392:1789-1858.
- Diamond S, Bigal ME, Silberstein S, et al. Patterns of
diagnosis and acute and preventive treatment for migraine in
the United States: results from
the American Migraine Prevalence and Prevention study.
Headache. 2007;47(3):355-363.
CONTACT: Amgen, Thousand Oaks
Megan Fox, 805-447-1423 (media)
Trish Rowland, 805-447-5631
(media)
Arvind Sood, 805-447-1060
(investors)
View original content to download
multimedia:http://www.prnewswire.com/news-releases/amgen-and-novartis-partner-with-karamo-brown-to-support-and-empower-people-living-with-migraine-301186712.html
SOURCE Amgen