THOUSAND OAKS, Calif.,
Dec. 2, 2016 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced the
submission of a Marketing Authorization Application (MAA) to the
European Medicines Agency (EMA) for ABP 215, a biosimilar candidate
to Avastin® (bevacizumab). The companies believe this
submission is the first bevacizumab biosimilar application
submitted to the EMA.
"The submission of ABP 215 to the EMA is an important milestone
as Amgen seeks to expand our oncology portfolio," said Sean E. Harper, M.D., executive vice president
of Research and Development at Amgen. "Amgen is committed to
delivering medicines to patients worldwide and ABP 215 has the
potential to offer an additional high-quality therapeutic option
for patients diagnosed with cancer."
"The EMA submission of ABP 215
marks an important step forward in providing a potential
therapeutic option for patients diagnosed with cancer. Allergan is
committed to globally developing high-quality therapies in critical
disease areas," said David
Nicholson, Chief Research and Development Officer at
Allergan.
ABP 215 is a biosimilar candidate to bevacizumab, a recombinant
immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds to
vascular endothelial growth factor (VEGF) and inhibits the
interaction of VEGF with its receptors, VEGF receptor-1 and VEGF
receptor-2, thus inhibiting establishment of new blood vessels
necessary for the maintenance and growth of solid tumors.
The MAA submission includes analytical, pharmacokinetic and
clinical data, as well as pharmacology and toxicology data. The
Phase 3 comparative efficacy, safety and immunogenicity study was
conducted in adult patients with non-squamous non-small cell lung
cancer (NSCLC). The Phase 3 study confirmed no clinically
meaningful difference to bevacizumab in terms of efficacy, safety
and immunogenicity.
About ABP 215
ABP 215 is being developed as a
biosimilar to bevacizumab, which is approved in the U.S., EU and
other regions for the treatment of patients with unresectable,
locally advanced, recurrent or metastatic non-squamous NSCLC as
well as metastatic carcinoma of the colon or rectum; metastatic
renal cell carcinoma; and other region-specific
indications.
About the Amgen and Allergan Collaboration
In
December 2011, Amgen
and Allergan plc. (then Watson Pharmaceuticals, Inc.) formed a
collaboration to develop and commercialize, on a worldwide basis,
four oncology antibody biosimilar medicines. This collaboration
reflects the shared belief that the development and
commercialization of biosimilar products will not follow a pure
brand or generic model, and will require significant expertise,
infrastructure, and investment to ensure safe, reliably supplied
therapies for patients. Under the terms of the
agreement, Amgen will assume primary responsibility for
developing, manufacturing and initially commercializing the
oncology antibody products.
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 will help to
maintain Amgen's commitment to connect patients with vital
medicines, and Amgen is well positioned to leverage its more than
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.
About Allergan plc
Allergan plc (NYSE: AGN),
headquartered in Dublin, Ireland,
is a bold, global pharmaceutical company and a leader in a new
industry model – Growth Pharma. Allergan is focused on
developing, manufacturing and commercializing branded
pharmaceuticals, devices and biologic products for patients around
the world.
Allergan markets a portfolio of leading brands and best-in-class
products for the central nervous system, eye care, medical
aesthetics and dermatology, gastroenterology, women's health,
urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company's
R&D model, which defines our approach to identifying and
developing game-changing ideas and innovation for better patient
care. This approach has led to Allergan building one of the
broadest development pipelines in the pharmaceutical industry with
70+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 16,000 global
colleagues' commitment to being Bold for Life. Together, we
build bridges, power ideas, act fast and drive results for our
customers and patients around the world by always doing what is
right.
With commercial operations in approximately 100 countries,
Allergan is committed to working with physicians, healthcare
providers and patients to deliver innovative and meaningful
treatments that help people around the world live longer, healthier
lives every day.
For more information, visit Allergan's website at
www.Allergan.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 its 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 Amgen project. Amgen's
results may be affected by its 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 its products and global economic conditions. In
addition, sales of Amgen's 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, Amgen's research, testing, pricing,
marketing and other operations are subject to extensive regulation
by domestic and foreign government regulatory authorities. Amgen or
others could identify safety, side effects or manufacturing
problems with its products after they are on the market. Amgen's
business may be impacted by government investigations, litigation
and product liability claims. In addition, Amgen's business may be
impacted by the adoption of new tax legislation or exposure to
additional tax liabilities. If Amgen fails to meet the compliance
obligations in the corporate integrity agreement between it and the
U.S. government, Amgen could become subject to significant
sanctions. Further, while Amgen routinely obtains patents for its
products and technology, the protection offered by its patents and
patent applications may be challenged, invalidated or circumvented
by its competitors, or Amgen may fail to prevail in present and
future intellectual property litigation. Amgen performs a
substantial amount of its commercial manufacturing activities at a
few key manufacturing facilities and also depends on third parties
for a portion of its manufacturing activities, and limits on supply
may constrain sales of certain of its current products and product
candidate development. In addition, Amgen competes with other
companies with respect to many of its marketed products as well as
for the discovery and development of new products. 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, some raw materials, medical
devices and component parts for Amgen's products are supplied by
sole third-party suppliers. 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 its business and results of
operations. Amgen's efforts to acquire other companies or products
and to integrate the operations of companies Amgen has acquired may
not be successful. Amgen may not be able to access the capital and
credit markets on terms that are favorable to it, or at all. Amgen
is increasingly dependent on information technology systems,
infrastructure and data security. Amgen's stock price may be
volatile and may be affected by a number of events. Amgen's
business performance could affect or limit the ability of the Amgen
Board of Directors to declare a dividend or its ability to pay a
dividend or repurchase its 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 the European Medicines Agency, and no conclusions
can or should be drawn regarding the safety or effectiveness of the
product candidates.
Allergan plc Forward-Looking Statement
Statements
contained in this press release that refer to future events or
other non-historical facts are forward-looking statements that
reflect Allergan's current perspective of existing trends and
information as of the date of this release. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements. Actual results may differ
materially from Allergan's current expectations depending upon a
number of factors affecting Allergan's business. These factors
include, among others, the difficulty of predicting the timing or
outcome of FDA approvals or actions, if any; the impact of
competitive products and pricing; market acceptance of and
continued demand for Allergan's products; difficulties or delays in
manufacturing; and other risks and uncertainties detailed in
Allergan's periodic public filings with the Securities and Exchange
Commission, including but not limited to Allergan's Annual Report
on Form 10-K for the year ended December 31,
2015 and Quarterly Report on Form 10-Q for the quarter ended
September 30, 2016 (certain of such
periodic public filings having been filed under the "Actavis plc"
name). Except as expressly required by law, Allergan disclaims any
intent or obligation to update these forward-looking
statements.
Avastin® is a registered trademark of Genentech,
Inc.
CONTACT: Amgen, Thousand
Oaks
Kristen Neese, 805-313-8267
(media)
Kristen Davis, 805-447-3008
(media)
Arvind Sood, 805-447-1060
(investors)
Amgen, Europe
Emma Gilbert, +41 41 369 2542
CONTACT: Allergan plc.
Lisa Defrancesco, 862-261-7152
(investors)
Mark Marmur, 862-261-7558
(media)
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