THOUSAND OAKS, Calif.,
Dec. 19, 2019 /PRNewswire/
-- Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today
announced the submission of a Biologics License Application (BLA)
to the U.S. Food and Drug Administration (FDA) for ABP 798, a
biosimilar candidate to Rituxan® (rituximab). Amgen and
Allergan are collaborating on four oncology biosimilar medicines,
two of which have already been approved by the FDA.
"The U.S. filing for ABP 798 marks
an important milestone for Amgen, as it affirms our commitment to
providing high quality biosimilars that offer more life-altering
biological treatment options and contribute to the sustainability
of healthcare systems," said David M.
Reese, M.D., executive vice president of Research and
Development at Amgen. "We look forward to working with the FDA to
bring ABP 798 to market."
ABP 798 has been developed as a biosimilar candidate to Rituxan.
Rituxan is a CD20-directed cytolytic antibody that has been
approved in many regions for, among other things, the treatment of
adult patients alone or in combination with chemotherapy for
non-Hodgkin's lymphoma, in combination with fludarabine and
cyclophosphamide for chronic lymphocytic leukemia, granulomatosis
with polyangiitis and microscopic polyangiitis with
glucocorticoids.
"We are excited about the progress that we've made to date
through our partnership with Amgen, which includes the launch of
the first two oncology therapeutic biosimilars in the U.S.," said
David Nicholson, Ph.D., chief
research and development officer at Allergan. "With ABP 798, we
look forward to the opportunity to continue to provide additional
treatment options to patients suffering from serious
illnesses."
The BLA submission includes analytical, pharmacokinetic and
clinical data, as well as pharmacology and toxicology data
generated in two clinical studies. The results of these studies
confirmed no clinically meaningful differences between ABP 798 and
Rituxan.
Amgen has a total of 10 biosimilars in its portfolio, four of
which have been approved in the U.S. and three that are approved in
the European Union (EU).
About ABP 798
ABP 798 has been developed as a
biosimilar candidate to Rituxan. Rituxan is an anti-CD20 monoclonal
antibody that has been approved in many regions for the treatment
of, among other things, adult patients alone or in combination with
chemotherapy for non-Hodgkin's lymphoma, in combination with
fludarabine and cyclophosphamide for chronic lymphocytic
leukemia, granulomatosis with polyangiitis and microscopic
polyangiitis with glucocorticoids. The active ingredient of ABP 798
is a monoclonal antibody that has the same amino acid sequence as
Rituxan.
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 assumes primary responsibility for
developing, manufacturing and initially commercializing the
oncology antibody products.
About Amgen Biosimilars
Amgen 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 nearly four decades 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 Oncology
Amgen is searching for and
finding answers to incredibly complex questions that will advance
care and improve lives for cancer patients and their families. Our
research drives us to understand the disease in the context of the
patient's life – not just their cancer journey – so they can take
control of their lives.
For the last four decades, we have been dedicated to discovering
the firsts that matter in oncology and to finding ways to reduce
the burden of cancer. Building on our heritage, Amgen continues to
advance the largest pipeline in the Company's history, moving with
great speed to advance those innovations for the patients who need
them.
At Amgen, we are driven by our commitment to transform the lives
of cancer patients and keep them at the center of everything we
do.
For more information, follow us on
www.twitter.com/amgenoncology
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 leader. Allergan is focused
on developing, manufacturing and commercializing branded
pharmaceutical, device, biologic, surgical and regenerative
medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class
products primarily focused on four key therapeutic areas including
central nervous system, eye care, medical aesthetics and
gastroenterology.
Allergan is an industry leader in Open Science, a model of
research and development, which defines our approach to identifying
and developing game-changing ideas and innovation for better
patient care. With this approach, Allergan has built one of the
broadest development pipelines in the pharmaceutical industry.
Allergan's success is powered by our 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 any statements on the
outcome, benefits and synergies of collaboration with any other
company, including BeiGene, Ltd. or the Otezla®
(apremilast) acquisition, including anticipated Otezla sales growth
and the timing of non-GAAP EPS accretion, as well as 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 current reports on 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, including our devices, 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. 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, including in Puerto Rico, 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. We rely on collaborations with third parties
for the development of some of our product candidates and for the
commercialization and sales of some of our commercial products. 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. Certain of our distributors, customers and payers have
substantial purchasing leverage in their dealings with us. 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 collaborate
with or acquire other companies or products and to integrate the
operations of companies or in support of products we have acquired,
may not be successful. A breakdown, cyberattack or information
security breach could compromise the confidentiality, integrity and
availability of our systems and our data. 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. We may not be able to access the
capital and credit markets on terms that are favorable to us, or at
all.
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.
Allergan plc Forward-Looking Statements
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 on existing trends and
information as of the date of this release. 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; the impact of uncertainty
around timing of generic entry related to key products, including
RESTASIS®, on our financial results; risks associated
with divestitures, acquisitions, mergers and joint ventures; risks
related to impairments; uncertainty associated with financial
projections, projected cost reductions, projected debt reduction,
projected synergies, restructurings, increased costs, and adverse
tax consequences; 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, 2018
and Allergan's Quarterly Report on Form 10-Q for the period ended
March 31, 2019. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements.
Rituxan® is a registered trademark of Biogen Inc.
CONTACT: Amgen, Thousand
Oaks
Kelley Davenport, 202-585-9637
(media)
Trish Hawkins, 805-447-5631
(media)
Arvind Sood, 805-447-1060
(investors)
CONTACT: Allergan plc.
Daphne Karydas, 862-261-8006
(investor relations)
Frances DeSena , 862-261-8820 (media
relations)
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