THOUSAND OAKS, Calif.,
April 24, 2017 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced an expanded commercial
collaboration with Novartis for erenumab, which is being
investigated for the prevention of migraine. This expanded
commercial collaboration builds on a global neuroscience
collaboration in Alzheimer's disease and migraine established in
2015 between Novartis and Amgen. This expanded collaboration
leverages Novartis' strong and established presence in neuroscience
to more effectively reach people with migraine. The companies have
agreed to combine capabilities to co-commercialize erenumab in the
U.S. Amgen retains exclusive commercialization rights in
Japan. Novartis gains exclusive
rights to commercialize erenumab in Canada, and retains its existing
commercialization rights in rest of the world. The companies will
continue global co-development.
Erenumab is a fully human monoclonal antibody specifically
designed to target and block the Calcitonin Gene-Related Peptide
(CGRP) receptor, believed to have a critical role in mediating the
incapacitating pain of migraine. Positive data from a Phase 2 study
and positive top-line results for two Phase 3 studies in migraine
prevention were announced in 2016. Detailed results from the Phase
3 studies will be presented at the annual meeting of the American
Academy of Neurology and submitted for publication. These data will
help support discussions with regulatory agencies, with filing
anticipated in the second quarter of 2017.
Under the terms of the agreement, Amgen will receive milestone
payments from Novartis expected to begin in 2017. Novartis will
share U.S. commercialization costs with Amgen. Amgen will book
sales of erenumab in the U.S., and will pay a royalty to Novartis
on net sales in the U.S. Novartis will book sales in the rest of
the world, excluding Japan, and
will pay Amgen royalties on the net sales in those countries. Amgen
will book sales in Japan, since it
will remain an exclusive territory for the Company. Novartis will
assume agreed upon remaining global development costs up to a cap
and share global development costs thereafter.
"Migraine is a debilitating disease and today many patients are
sub-optimally treated due to tolerability issues with existing
therapies," said Anthony C. Hooper,
executive vice president of Global Commercial Operations at Amgen.
"Combining the U.S. capabilities of Amgen and Novartis in
preparation for the launch of erenumab can create meaningful value
over the life of this first-in-class program by enabling us to more
effectively, and perhaps even more rapidly, reach people who live
with the impact of migraine on a daily basis."
This is an expansion of a global collaboration with Novartis
announced in September 2015 in
neuroscience, involving joint development and commercialization of
pioneering treatments in the field of Alzheimer's disease and
migraine.
About Erenumab
Erenumab is a fully human monoclonal
antibody specifically designed for the prevention of migraine.
Erenumab targets and blocks the Calcitonin Gene-Related Peptide
(CGRP) receptor, thought to be pivotal in the genesis of migraine.
Erenumab has been studied in several large global, randomized,
double-blind, placebo-controlled studies to assess its safety and
efficacy in migraine prevention. Positive results from a Phase 2
study and positive top-line data from two Phase 3 studies in
migraine prevention were announced in 2016. These data will help
support discussions with regulatory agencies, with filings
anticipated in 2017.
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 because of intolerable side effects or
limited efficacy.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
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 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 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. We or others could identify safety, side effects or
manufacturing problems with our products after they are on the
market. 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
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
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.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(Media)
Kristen Neese, 805-313-8267
(Media)
Arvind Sood, 805-447-1060
(Investors)
References
1. Migraine Research Foundation. Migraine Fact Sheet. 2015.
Available:
http://www.migraineresearchfoundation.org/fact-sheet.html.
Accessed April 7, 2017.
2. World Health Organization. Headache Disorder Fact Sheet.
Available: http://www.who.int/mediacentre/factsheets/fs277/en/.
Accessed April 7, 2017.
3. Lipton RB, et al. Migraine prevalence, disease burden, and the
need for preventative therapy. Neurology. 2007; 68(5):343-9.
4. Marketscan data on file. 3-24-2017. Ref Type: Data
File
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/amgen-announces-expanded-commercial-collaboration-with-novartis-for-erenumab-in-migraine-300444425.html
SOURCE Amgen