THOUSAND OAKS, Calif.,
July 12, 2016 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced that the Company will
discuss data supporting the ABP 501 Biologics License Application
(BLA) with the U.S. Food and Drug Administration's (FDA) Arthritis
Advisory Committee. ABP 501 is a biosimilar candidate to
Humira® (adalimumab), an anti-tumor necrosis
factor-alpha (TNF-α) monoclonal antibody, which is approved in many
regions for the treatment of several inflammatory diseases.
During the meeting, Amgen will present a comprehensive data
package which supports biosimilarity of ABP 501 to adalimumab based
on analytical, nonclinical, clinical and pharmacokinetic data,
including results from two Phase 3 studies conducted in
moderate-to-severe plaque psoriasis and moderate-to-severe
rheumatoid arthritis. The Phase 3 studies met their primary
endpoints showing clinical comparability to adalimumab. Safety and
immunogenicity of ABP 501 were also comparable to
adalimumab.
"As a developer of innovative medicines and biosimilars, Amgen
has worked diligently to apply our more than 35 years of experience
in biotechnology to the development of biosimilars," said
Sean E. Harper, M.D., executive vice
president of Research and Development at Amgen. "Today, we're
looking forward to discussing the efficacy, safety and
immunogenicity profile of ABP 501, Amgen's first prospective
biosimilar, with the FDA advisory committee. If approved, ABP 501
has the potential to provide an additional treatment option for
patients with chronic inflammatory diseases, as well as play a key
role in long-term disease management."
The FDA has set a Biosimilar User Fee Act (BsUFA) target action
date of Sept. 25, 2016 for ABP
501.
About ABP 501
ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α
monoclonal antibody, which is approved in many regions for the
treatment of several inflammatory diseases. The active ingredient
of ABP 501 is an anti-TNF-α monoclonal antibody that has the same
amino acid sequence as adalimumab. ABP 501 has the same
pharmaceutical dosage form and strength as adalimumab (U.S.) and
adalimumab (EU).
About Amgen Biosimilars
Amgen Biosimilars is committed to building upon Amgen's
experience in the development and manufacturing of innovative human
therapeutics to expand Amgen's reach to patients with serious
illnesses. Biosimilars offer the potential to increase patient
access to vital medicines, and Amgen is well positioned to leverage
its 35 years of experience in biotechnology to create high-quality
biosimilars and reliably supply them to patients worldwide.
For more information, visit www.amgenbiosimilars.com and follow
us on www.twitter.com/amgenbiosim.
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. 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
related to our product candidates is preliminary and investigative.
Such product candidates are not approved by the U.S. Food and Drug
Administration or European Commission, and no conclusions can or
should be drawn regarding the safety or effectiveness of the
product candidates.
Humira® is a registered trademark of AbbVie Inc.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(investors)
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SOURCE Amgen