THOUSAND OAKS, Calif.,
Sept. 1, 2015 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced a neuroscience
collaboration with Novartis in the areas of Alzheimer's disease and
migraine. The collaboration accelerates Amgen's potential entry
into Alzheimer's disease by teaming up with Novartis on a
differentiated and genetically validated Alzheimer's disease
program directed at genetically predisposed individuals at risk of
developing Alzheimer's disease. The collaboration also enables
Amgen to focus on the commercialization of its migraine programs in
the U.S., Canada and Japan, while leveraging Novartis' strong
commercial capabilities in neuroscience throughout Europe and other markets worldwide.
The agreement combines each company's BACE (beta-site
APP-cleaving enzyme-1) programs targeting Alzheimer's disease into
a global co-commercialization and co-development arrangement.
Novartis' Phase 1/2a BACE inhibitor (CNP520) will be the lead
molecule and each company's pre-clinical BACE inhibitor programs
will be potential follow-ons. Amgen will make upfront and milestone
payments, and will be responsible for disproportional research and
development (R&D) costs for an agreed-upon period followed by a
50/50 cost and profit share arrangement. CNP520 is planned to be
included in a pioneering prevention study, in collaboration with
the Banner Alzheimer's Institute. Amgen was the first company to
clone the BACE gene and subsequent genetic validation of the BACE
target has been confirmed by Amgen subsidiary deCODE Genetics.
As part of the collaboration, Novartis receives global
co-development rights and commercial rights outside of the U.S.,
Canada and Japan to the investigative molecules in
Amgen's migraine portfolio program. This includes AMG 334 in Phase
3 and AMG 301 in Phase 1, as well as an option to commercialize an
additional early-stage Amgen molecule in these territories. In
exchange for territory rights, Novartis will fund disproportional
amounts of global R&D expenses for an agreed-upon period on the
migraine programs and pay Amgen double-digit royalties on
sales.
"We are very pleased to be joining forces with Novartis on two
important neuroscience programs where there remains high unmet
medical need," said Sean E. Harper,
M.D., executive vice president of Research and Development at
Amgen. "Our collaboration on BACE inhibition reflects Amgen's
strategic focus on genetically validated drug candidates while our
collaboration in migraine creates an opportunity to more rapidly
advance AMG 334 on a global scale."
About CNP520
Novartis' CNP520 is an oral drug designed
to prevent the production of different forms of amyloid and has the
potential to prevent, slow or delay the symptoms associated with
Alzheimer's disease. It is currently in Phase 1/2a trials.
About Amgen's BACE Research
BACE (beta-site
APP-cleaving enzyme-1) initiates the production of beta amyloid
(Ab), the primary constituent of amyloid plaques that are believed
to play a key role in the etiology of Alzheimer's disease. It is
hypothesized that inhibiting BACE could reduce the production of
amyloid plaques. Amgen was the first to clone and characterize BACE
in a 1999 Science publication.1 Amgen subsidiary
deCODE Genetics subsequently added corroborating human genetic
evidence of its link to Alzheimer's disease in a 2012 Nature
publication.2 Amgen has a number of preclinical
candidates targeting BACE inhibition.
About Novartis' Collaboration with the Banner
Alzheimer's Institute
In collaboration with the
Banner Alzheimer's Institute (BAI), Novartis is conducting a
pioneering prevention study. The study with BAI is part of a
ground-breaking research program known as the Alzheimer's
Prevention Initiative and will involve more than 1,300 cognitively
healthy adults, ages 60 to 75, with a genetic risk of developing
symptoms of Alzheimer's disease because they inherited two genetic
copies of the apolipoprotein E epsilon 4 (APOE4) allele – one from
each parent. About 2 percent of the world's population has this
genetic profile, which is strongly linked to late-onset Alzheimer's
disease. One in four people carries one copy of the APOE4 gene.
Participants in the study will be given either CNP520, CAD106 (not included in the collaboration with
Amgen), or placebo. Pending regulatory approval, the study is
planned to start in late 2015/early 2016 in sites in North America and Europe.
About Alzheimer's Disease
Alzheimer's disease, the
most common type of dementia, is a progressive neurodegenerative
disease that begins with microscopic changes in the brain.
Alzheimer's disease causes problems with memory, thinking and
behavior. Symptoms of the disease develop slowly and worsen over
time. Two important components of Alzheimer's disease are amyloid
plaques and inflammation, the combination of which is believed to
lead to a loss of synapses and neuronal death. The disease
continuum can span decades with the initial amyloid accumulation
occurring many years before the first signs of memory loss appear.
It is estimated that approximately 44 million people globally have
Alzheimer's disease or a related dementia.3 The global
direct costs of Alzheimer's disease are estimated to be more than
$600 billion.4
About AMG 334
AMG 334 is a fully human
monoclonal antibody under investigation for the prevention of
migraine. AMG 334 targets the calcitonin gene-related peptide
(CGRP) receptor, 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 AMG 301
AMG 301 is a monoclonal
antibody being investigated for the treatment of migraine.
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.5 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.6 Migraine also has a
tremendous impact on patients' everyday lives, including work
productivity and social interactions.7,8 More than half
of people living with migraine will go undiagnosed.9
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) 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 (SEC) 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 Amgen's business. Unless otherwise
noted, Amgen is providing this information as
of Sept. 1, 2015, and expressly disclaims 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 Amgen projects.
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 Amgen and its partners
to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied
and Amgen expects similar variability in the
future. Amgen develops 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 Amgen may have believed at the
time of entering into such relationship. Also, Amgen or
others could identify safety, side effects or manufacturing
problems with Amgen's products after they are on the
market. Amgen's business may be impacted by government
investigations, litigation and product liability claims.
If Amgen fails to meet the compliance obligations in the
corporate integrity agreement between Amgen and the U.S.
government, Amgen could become subject to significant
sanctions. Amgen depends on third parties for a
significant portion of its manufacturing capacity for the supply of
certain of its current and future products and limits on supply may
constrain sales of certain of its current products and product
candidate development.
In addition, sales of Amgen's products are affected by
the 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 as well as U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government and others'
regulations and reimbursement policies may affect the development,
usage and pricing of Amgen's products. In
addition, Amgen competes with other companies with
respect to some of its marketed products as well as for the
discovery and development of new products. Amgen believes that
some of its newer products, product candidates or new indications
for existing products, may face competition when and as they are
approved and marketed. Amgen's products may compete
against products that have lower prices, established reimbursement,
superior performance, are easier to administer, or that are
otherwise competitive with its products. In addition,
while Amgen and its partners routinely obtain patents for
their products and technology, the protection
of Amgen's products offered by patents and patent
applications may be challenged, invalidated or circumvented by its
competitors and there can be no guarantee of Amgen's or
its partners' ability to obtain or maintain patent protection
for Amgen's products or product
candidates. Amgen cannot guarantee that it will be able
to produce commercially successful products or maintain the
commercial success of its existing
products. Amgen's stock price may be affected by actual
or perceived market opportunity, competitive position and success
or failure of its products or product candidates. Further, the
discovery of significant problems with a product similar to one
of Amgen's products that implicate an entire class of
products could have a material adverse effect on sales of the
affected products and on Amgen's business and results of
operations. Amgen's efforts to integrate the operations
of companies it has acquired may not be
successful. Amgen may experience difficulties, delays or
unexpected costs and not achieve anticipated cost savings from its
ongoing restructuring plan. Amgen's business performance
could affect or limit the ability of Amgen's Board of
Directors to declare a dividend or their ability to pay a dividend
or repurchase Amgen common stock.
The scientific information discussed in this news release
related to Amgen's product candidates is preliminary and
investigative. Such product candidates are not approved by
the U.S. Food and Drug Administration (FDA), 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)
Kristen Neese,
805-313-8267 (media)
Arvind Sood, 805-447-1060
(investors)
References
1 Vassar, R. et al.
"β-Secretase cleavage of Alzheimer's amyloid precursor protein by
the transmembrane aspartic protease BACE." Science 286.5440 (1999):
735-741.
2 Supporting deCODE genetic evidence: Jonsson, T.
et al. "A mutation in APP protects against Alzheimer's disease and
age-related cognitive decline." Nature 488.7409 (2012): 96-99.
3 Policy Brief for Heads of Government: The Global
Impact of Dementia 2013-2015, Alzheimer's Disease International
(ADI), December 2013.
4 New Report Reveals Global Cost of Alzheimer's and
Related Dementias is More Than $600
Billion, Alzheimer's Association, 2010.
5 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.
6 National Institute for Neurological Disorders and
Stroke. Headache: Hope Through Research.
http://www.ninds.nih.gov/disorders/headache/detail_headache.htm.
Accessed June 4, 2015.
7 Migraine Research Foundation. Migraine Fact Sheet.
2015. Available:
http://www.migraineresearchfoundation.org/fact-sheet.html.
Accessed June 4, 2015.
8 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).
9 National Headache Foundation. Migraine.
Oct 2007. Available:
http://www.headaches.org/2007/10/25/migraine/. Accessed
June 4, 2015.
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