THOUSAND OAKS, Calif.,
July 13, 2017 /PRNewswire/
-- Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today
announced that the Companies will discuss data supporting the ABP
215 Biologics License Application (BLA) with the Oncologic
Drugs Advisory Committee (ODAC) of the U.S. Food and Drug
Administration (FDA). ABP 215 is a biosimilar candidate to
Avastin® (bevacizumab) and is the first bevacizumab
biosimilar candidate to be considered by the FDA.
"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 comprehensive data package for
ABP 215, Amgen's first prospective oncologic biosimilar, with the
FDA advisory committee."
During the meeting, Amgen will present a comprehensive data
package including the analytical, pharmacokinetic and clinical
data, which demonstrate ABP 215 and bevacizumab are highly similar,
with no clinically meaningful differences in terms of the efficacy,
safety and immunogenicity between the products. Clinical studies
included results from a Phase 3 study in patients with non-squamous
non-small cell lung cancer (NSCLC), which met its primary endpoint
of showing clinical equivalence to bevacizumab.
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.
"ABP 215 is the first product of our collaboration with Amgen to
reach this important milestone," said David
Nicholson, chief R&D officer at Allergan. "If approved,
ABP 215 has the potential to provide another high quality treatment
option for cancer patients and pave the way for additional high
quality oncology biosimilars from Allergan and Amgen."
The FDA is not bound by the Committee's recommendation but does
takes its advice into consideration when considering the approval
of a new therapeutic. The FDA has set a Biosimilar User
Fee Act (BsUFA) target action date of Sept. 14, 2017, for
ABP 215.
Amgen and Allergan are collaborating on the development and
commercialization of four oncology biosimilars. Amgen has a total
of 10 biosimilars in its portfolio, one which has been approved by
the FDA.
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. On
Dec. 2, 2016, Amgen and Allergan also
submitted a Marketing Authorization Application to the European
Medicines Agency for ABP 215.
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'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.
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 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 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. 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.
The scientific information discussed in this news release
related to Amgen's 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.
Avastin® is a registered trademark of
Genentech.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(investors)
CONTACT: Allergan plc.
Daphne Karydas, 862-261-8006
(investor relations)
Mark Marmur, 862-261-7558
(media)
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