THOUSAND OAKS, Calif.,
May 22, 2015 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced the Company has
commenced termination of its participation in the co-development
and commercialization of brodalumab with AstraZeneca (LON:AZN,
STO:AZN and NYSE:AZN). Brodalumab, an investigational IL-17
inhibitor, is in development for patients with moderate-to-severe
plaque psoriasis, psoriatic arthritis, and axial
spondyloarthritis. The decision was based on events of
suicidal ideation and behavior in the brodalumab program, which
Amgen believes likely would necessitate restrictive labeling.
"During our preparation process for regulatory submissions, we
came to believe that labeling requirements likely would limit the
appropriate patient population for brodalumab," said Sean E. Harper, M.D., executive vice president
of Research and Development at Amgen.
After Amgen transitions the program to AstraZeneca, future
decisions on the clinical development and submission of marketing
applications for brodalumab will be at the sole discretion of
AstraZeneca for all territories, except for certain Asian
territories, including Japan,
where Kyowa Hakko Kirin has rights to brodalumab.
Amgen has decided to focus its efforts and resources on other
key molecules that address unmet medical needs and deliver value to
patients and shareholders. The Company continues to make
progress against its strategic and financial commitments and does
not expect any meaningful impact from this decision on its ability
to meet them.
About the Amgen and AstraZeneca Collaboration
In April 2012, Amgen and
AstraZeneca formed a collaboration to jointly develop and
commercialize five monoclonal antibodies from Amgen's clinical
inflammation portfolio. With oversight from joint governing bodies,
Amgen leads clinical development and commercialization for
brodalumab and AMG 557/MEDI5872 (Phase 1b for autoimmune diseases,
such as systemic lupus erythematosus). AstraZeneca, through its
biologics arm MedImmune, leads clinical development and
commercialization for MEDI7183/AMG 181 (Phase 2 for ulcerative
colitis and Crohn's disease), MEDI2070/AMG 139 (Phase 2 for Crohn's
disease) and MEDI9929/AMG 157 (Phase 2 for asthma).
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 management's current expectations and beliefs 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, including Amgen'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's most recent Forms 10-K, 10-Q and 8-K for
additional information on the uncertainties and risk factors
related to our business. Unless otherwise noted, Amgen is providing
this information as of May 22, 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 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. 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 business may be impacted by
government investigations, litigation and products liability
claims. We depend on third parties for a significant portion of our
manufacturing capacity for the supply of certain of our current and
future products and limits on supply may constrain sales of certain
of our current products and product candidate development.
In addition, sales of our products are affected by the
reimbursement policies imposed by third-party payors, 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 our products. In addition, we compete with
other companies with respect to some of our marketed products as
well as for the discovery and development of new products. We
believe that some of our newer products, product candidates or new
indications for existing products, may face competition when and as
they are approved and marketed. Our products may compete against
products that have lower prices, established reimbursement,
superior performance, are easier to administer, or that are
otherwise competitive with our products. In addition, 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 and
there can be no guarantee of our ability to obtain or maintain
patent protection for our products or product candidates. We cannot
guarantee that we will be able to produce commercially successful
products or maintain the commercial success of our existing
products. Our stock price may be affected by actual or perceived
market opportunity, competitive position, and success or failure of
our products or product candidates. Further, 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 integrate the
operations of companies we have acquired may not be successful. We
may experience difficulties, delays or unexpected costs and not
achieve anticipated benefits and savings from our recently
announced restructuring plan. Our business performance could
affect or limit the ability of our Board of Directors to declare a
dividend or their ability to pay a dividend or repurchase our
common stock.
CONTACT: Amgen, Thousand
Oaks
Trish Hawkins, 805-447-5631
(media)
Arvind Sood, 805-447-1060
(investors)
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SOURCE Amgen