THOUSAND OAKS, Calif.,
March 23, 2018 /PRNewswire/
-- Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today
announced that the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) has adopted a
positive opinion for the marketing authorization of ABP 980, a
biosimilar to Herceptin® (trastuzumab). ABP 980 has been
recommended for approval for the treatment of the same three types
of cancer as Herceptin is approved for in the European Union (EU),
including HER2-positive metastatic breast cancer, HER2-positive
early breast cancer and HER2-positive metastatic adenocarcinoma of
the stomach or gastroesophageal junction.
"The positive opinion issued by the CHMP for ABP 980 marks an important step for our biosimilar
portfolio, as it's our second oncology biosimilar to reach this
important milestone, and further underscores our commitment to
providing the oncology community access to high-quality cancer
therapies," said Sean E. Harper,
M.D., executive vice president of Research and Development at
Amgen. "We look forward to continuing our work with Allergan and
European regulatory authorities to bring additional options to
patients with cancer."
The Marketing Authorization Application for ABP 980 was
supported by 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
female patients with HER2-positive early breast cancer.
"We are committed to providing patients with important medicines
to help them fight cancer," said David
Nicholson, chief research and development officer at
Allergan. "The CHMP's positive opinion for the marketing
authorization of ABP 980 reinforces its potential to increase
physician choice and patient access to an important biologic."
The CHMP positive opinion will now be reviewed by
the European Commission (EC), which has the authority to
approve medicines for the EU. If approved, a centralized
marketing authorization will be granted that will be valid in the
28 countries that are members of the
EU. Norway, Iceland and Liechtenstein, as
members of the European Economic Area (EEA), will take
corresponding decisions on the basis of the EC's decision.
Amgen and Allergan are collaborating on the development and
commercialization of four oncology biosimilars. Amgen has a total
of 10 biosimilars in its portfolio, two of which have been approved
by the EC.
About ABP 980
ABP 980 is being developed as a biosimilar to trastuzumab, a
recombinant DNA-derived humanized monoclonal immunoglobulin G1
kappa antibody approved in many regions for the treatment of
HER2-overexpressing early breast cancer, adjuvant breast cancer,
metastatic breast cancer and metastatic gastric cancer. The active
ingredient of ABP 980 is a humanized monoclonal antibody that has
the same amino acid sequence as trastuzumab. ABP 980 has the same
pharmaceutical dosage form and same strength after reconstitution
as trastuzumab. Amgen and Allergan also submitted a
Biologics License Application to the U.S. Food and Drug
Administration (FDA) for ABP 980 in 2017.
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 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's Commitment to Oncology
Amgen Oncology is committed to helping patients take on some of
the toughest cancers, such as those that have been resistant to
drugs, those that progress rapidly through the body and those where
limited treatment options exist. Amgen's supportive care
treatments help patients combat certain side effects of strong
chemotherapy, and our targeted medicines and immunotherapies focus
on more than a dozen different malignancies, ranging from blood
cancers to solid tumors. With decades of experience providing
therapies for cancer patients, Amgen continues to grow
its portfolio of innovative and biosimilar oncology medicines.
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 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 Amgen projects. 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
Amgen to complete clinical trials and obtain regulatory approval
for product marketing has in the past varied and Amgen expects
similar variability in the future. Even when clinical trials are
successful, regulatory authorities may question the sufficiency for
approval of the trial endpoints Amgen has selected. Amgen develops
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 Amgen may
have believed at the time of entering into such relationship. Also,
Amgen or others could identify safety, side effects or
manufacturing problems with its products, including its devices,
after they are on the market.
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'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. Further, some raw materials, medical devices and
component parts for Amgen's products are supplied by sole
third-party suppliers. Certain of Amgen's distributors, customers
and payers have substantial purchasing leverage in their dealings
with Amgen. 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.
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; uncertainty
associated with financial projections, projected cost reductions,
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, 2016
and Allergan's Quarterly Report on Form 10-Q for the period ended
September 30, 2017. Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements.
Herceptin® is registered trademark of
Genentech.
CONTACT: Amgen, Thousand
Oaks
Kelley Davenport, 202-585-9637
(media)
Kristen Davis, 805-447-3008
(media)
Arvind Sood, 805-447-1060
(investors)
Amgen, Europe
Emma Gilbert, +41 41 369 2542
CONTACT: Allergan plc.
Daphne Karydas, 862-261-8006
(investor relations)
Mark Marmur, 862-261-7558
(media)
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SOURCE Amgen