THOUSAND OAKS, Calif. and
LONDON, Dec. 11, 2014 /PRNewswire/ -- Amgen (NASDAQ:
AMGN) and AstraZeneca (NYSE: AZN) today announced that additional
results from AMAGINE-1TM, a pivotal, multi-arm Phase 3
trial evaluating two doses of brodalumab in patients with
moderate-to-severe plaque psoriasis will be presented at the
Psoriasis: From Gene to Clinic International Congress in
London on Saturday, Dec. 13, 2014, at 11:20 a.m. GMT (Abstract FC30). Brodalumab is the
only investigational treatment in development that binds to the
interleukin-17 (IL-17) receptor and inhibits inflammatory signaling
by blocking the binding of several IL-17 cytokines (A, F and A/F)
to the receptor. The IL-17 receptor and cytokine family play a
central role in the development and clinical manifestations of
plaque psoriasis.
"We are excited to present additional data from AMAGINE-1, which
provide further insight into brodalumab's potential role in
addressing the unmet needs of patients living with psoriasis," said
Sean E. Harper, M.D., executive vice
president of Research and Development at Amgen. "We continue to be
encouraged by the emerging data from this program and look forward
to initiating global regulatory filings in 2015."
The AMAGINE-1 trial assessed the safety and efficacy of
brodalumab given every two weeks via subcutaneous injection at two
doses (140 mg or 210 mg) compared with placebo after 12 weeks of
treatment in patients with moderate-to-severe plaque psoriasis.
Another purpose of the study was to assess safety and efficacy when
patients treated with brodalumab, who responded to treatment,
continued receiving brodalumab compared to patients who had
treatment withdrawn and began receiving placebo. Data being
presented include results through week 52.
The AMAGINE program comprises three pivotal Phase 3 studies
designed to assess the efficacy and safety of brodalumab in more
than 4,200 patients with moderate-to-severe plaque psoriasis.
Positive top-line results from AMAGINE-1 were released in
May 2014. Positive top-line results
from AMAGINE-2TM and AMAGINE-3TM, comparing
brodalumab with Stelara® (ustekinumab) and placebo, were
announced in November 2014. AMAGINE-2
and AMAGINE-3 are identical in design.
About Brodalumab (AMG 827)
Brodalumab is a novel
human monoclonal antibody that binds to the interleukin-17 (IL-17)
receptor and inhibits inflammatory signaling by blocking the
binding of several IL-17 ligands to the receptor. By stopping IL-17
ligands from activating the receptor, brodalumab prevents the body
from receiving signals that may lead to inflammation. The IL-17
pathway plays a central role in inducing and promoting inflammatory
disease processes.1 In addition to moderate-to-severe
plaque psoriasis (Phase 3), brodalumab is currently being
investigated for the treatment of psoriatic arthritis (Phase 3) and
asthma (Phase 2).
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 (Phase 3 for
moderate-to-severe plaque psoriasis and psoriatic arthritis, Phase
2 for asthma) 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.
About AstraZeneca
AstraZeneca is a global,
innovation-driven biopharmaceutical business that focuses on the
discovery, development and commercialisation of prescription
medicines, primarily for the treatment of cardiovascular,
metabolic, respiratory, inflammation, autoimmune, oncology,
infection and neuroscience diseases. AstraZeneca operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. For more information please visit:
www.astrazeneca.com.
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,
we or us) 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 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 our business. Unless
otherwise noted, we are providing this information as of
Dec. 11, 2014, and expressly disclaim
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
and our partners 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 product
liability claims. 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. 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 (including products of our
wholly-owned subsidiaries) 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 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 and
our partners routinely obtain patents for our and their products
and technology, the protection of our products offered by patents
and patent applications may be challenged, invalidated or
circumvented by our or our partners' competitors and there can be
no guarantee of our or our partners' 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.
Cost savings initiatives may result in us incurring impairment or
other related charges on our assets. We may experience
difficulties, delays or unexpected costs and not achieve
anticipated benefits and savings from our recently announced
restructuring plans. 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 common stock.
The scientific information discussed in this news release
related to our product candidates is preliminary and
investigative. Such product candidates are not approved by
the U.S. Food and Drug Administration, and no conclusions can or
should be drawn regarding the safety or effectiveness of the
product candidates.
Stelara® is a registered trademark of Janssen
Biotech, Inc.
CONTACT: Amgen, Thousand
Oaks
Eva Groves, 805-447-2739 (media)
Kristen Davis, 805-447-3008
(media)
Arvind Sood, 805-447-1060
(investors)
CONTACT: AstraZeneca
Media:
Esra Erkal-Paler, +44 20 7604 8030
(UK/Global)
Michele Meixell, +1 302 885 2677
(US)
Investors:
Thomas Kudsk Larsen, +44 20 7604
8199, mob: +44 7818 524185
Karl Hård, +44 20 7604 8123, mob: +44 7789 654364
References:
- Miossec P, Korn T, Kuchroo VK. Interleukin-17 and Type 17
Helper T Cells. The New England Journal of Medicine. 2009; 361:
888-98.
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