THOUSAND OAKS, Calif. and
DUBLIN, Sept. 23, 2015 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced a Phase
3 study of biosimilar candidate ABP 215 met its primary and
secondary endpoints. The study evaluated the efficacy and safety of
ABP 215 compared with Avastin® (bevacizumab) in adult
patients with advanced non-squamous non-small cell lung cancer
(NSCLC).
The primary endpoint, an assessment of objective response rates
(ORR), was within the prespecified margin for ABP 215 compared to
bevacizumab, showing clinical equivalence. Safety and
immunogenicity of ABP 215 were comparable to bevacizumab. Secondary
endpoint results were consistent with the primary finding and
included risk difference of ORR, duration of response and
progression-free survival (PFS).
ABP 215 is being developed as a biosimilar 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.
"Amgen is committed to bringing high-quality, reliably supplied
medicines to patients and we're excited to leverage our development
and manufacturing capabilities in oncology for our biosimilars. The
positive Phase 3 results from ABP 215 study showed clinical
equivalence in efficacy, and comparable safety and immunogenicity,
to bevacizumab," said Sean E.
Harper, M.D., executive vice president of Research and
Development at Amgen. "Non-small cell lung cancer is the leading
cause of cancer death in both men and women in the U.S. and the EU.
ABP 215 holds the potential to advance access to treatment options
for oncology patients."
"The positive Phase 3 clinical results of ABP 215 mark an
important step forward in the development of biosimilar treatment
options for patients with advanced non-small cell lung cancer,"
said David Nicholson, executive vice
president and president of Global Research and Development of
Allergan. "Allergan is committed to developing biosimilars that
provide safe, high-quality and effective therapies in key disease
areas for patients."
Amgen and Allergan are collaborating on the development and
commercialization of four oncology biosimilars. Amgen has a total
of nine biosimilars in development. Allergan is also independently
developing biosimilars.
Study Design
This was a randomized, double-blind,
active-controlled study (study number 20120265) that evaluated
safety and efficacy of ABP 215 compared to bevacizumab in adult
patients with advanced non-squamous NSCLC receiving first-line
chemotherapy with carboplatin and paclitaxel. There were 642
patients enrolled and randomized (1:1) to receive investigational
product (ABP 215 or bevacizumab) at a dose of 15 mg/kg administered
as an IV infusion every 3 weeks (Q3W) for up to 6 cycles. Among
them, there were 328 patients randomized to the ABP 215 group and
314 patients to the bevacizumab group.
The duration of the treatment included a screening period of up
to 4 weeks, followed by up to 6 Q3W treatment cycles and an end of
treatment visit 21 days after the last dose of investigational
product or study specified chemotherapy. Following the end of
treatment visit, patients were followed for disease progression and
overall survival (OS) until the end of the clinical study, consent
was withdrawn, they were lost to follow-up, death or had proscribed
therapy (e.g. commercial bevacizumab, non-study anti-cancer
treatment).
Clinical equivalence of the primary endpoint was demonstrated by
comparing the confidence interval of the risk ratio in ORR between
ABP 215 and bevacizumab to a prespecified margin. Response was
determined by independent review based on RECIST criteria.
About Non-Small Cell Lung Cancer
Non-small cell lung
cancer (NSCLC) is the leading cause of cancer death in both men and
women in the U.S. and the European Union (EU). In the U.S., there
were an estimated 226,160 new cases and 160,340 deaths due to NSCLC
in 2012, and in the EU there were an estimated 265,600 new cases
and 236,000 deaths due to NSCLC in 2006.1,2 NSCLC arises
from the epithelial cells of the lung of the central bronchi to
terminal alveoli. The histological type of NSCLC depends on the
cells of origin, most commonly squamous cell carcinoma, large cell
carcinoma and adenocarcinoma. Cigarette smoking is the primary risk
factor for NSCLC, and other risks include exposure to second hand
smoke, family history, radon exposure and exposure to air
pollution.3-6
For patients with metastatic (Stage IV) NSCLC or recurrent NSCLC
following surgery and adjuvant chemotherapy, treatment usually
consists of combination chemotherapy with a platinum-based regimen,
such as cisplatin and gemcitabine or carboplatin and paclitaxel, in
repeated 3-week cycles for up to 6 cycles. For patients without
squamous cell histology or a recent history of hemoptysis, addition
of the anti-VEGF antibody bevacizumab to this regimen improves ORR
and prolongs PFS.7-9
Based on these and other data, bevacizumab has been approved in
the U.S., EU and elsewhere for first-line treatment in patients
with advanced or recurrent non-squamous NSCLC in combination with
platinum-based chemotherapy.
About ABP 215
ABP 215 is being developed as a
biosimilar to bevacizumab, which is approved in specific
combinations 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 suffering from 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 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 biologics manufacturing 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
Allergan plc (NYSE: AGN),
headquartered in Dublin, Ireland,
is a unique, global pharmaceutical company and a leader in a new
industry model – Growth Pharma. Allergan is focused on developing,
manufacturing and commercializing innovative branded
pharmaceuticals, high-quality generic and over-the-counter
medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that
provide valuable treatments for the central nervous system, eye
care, medical aesthetics, gastroenterology, women's health,
urology, cardiovascular and anti-infective therapeutic categories,
and operates the world's third-largest global generics business,
providing patients around the globe with increased access to
affordable, high-quality medicines. Allergan is an industry leader
in research and development, with one of the broadest development
pipelines in the pharmaceutical industry and a leading position in
the submission of generic product applications globally.
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.
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 Inc. and its subsidiaries
(Amgen, we or us) and are subject to a number of risks,
uncertainties and assumptions that could cause actual results to
differ materially from those described. 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 (SEC) reports filed by Amgen Inc., including Amgen
Inc.'s most recent annual report on Form 10-K and any subsequent
periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen
Inc.'s most recent Forms 10-K, 10-Q and 8-K for additional
information on the uncertainties and risk factors related to our
business. Unless otherwise noted, Amgen is providing this
information as of Sept. 23, 2015, and
expressly disclaims any duty to update information contained in
this news release.
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
and our partners to complete clinical trials and obtain regulatory
approval for product marketing has in the past varied and we expect
similar variability in the future. 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 business may be
impacted by government investigations, litigation and product
liability claims. 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. We
depend on third parties for a significant portion of our
manufacturing capacity for the supply of certain of our current and
future products and limits on supply may constrain sales of certain
of our current products and product candidate development.
In addition, sales of our products (including products of our
wholly-owned subsidiaries) are affected by the 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 as well as U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government and others'
regulations and reimbursement policies may affect the development,
usage and pricing of our products. In addition, we compete with
other companies with respect to some of our marketed products as
well as for the discovery and development of new products. We
believe that some of our newer products, product candidates or new
indications for existing products, may face competition when and as
they are approved and marketed. Our products may compete against
products that have lower prices, established reimbursement,
superior performance, are easier to administer, or that are
otherwise competitive with our products. In addition, while we and
our partners routinely obtain patents for our and their products
and technology, the protection of our products offered by patents
and patent applications may be challenged, invalidated or
circumvented by our or our partners' competitors and there can be
no guarantee of our or our partners' ability to obtain or maintain
patent protection for our products or product candidates. We cannot
guarantee that we will be able to produce commercially successful
products or maintain the commercial success of our existing
products. Our stock price may be affected by actual or perceived
market opportunity, competitive position, and success or failure of
our products or product candidates. Further, 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 integrate the
operations of companies we have acquired may not be successful.
Cost savings initiatives may result in us incurring impairment or
other related charges on our assets. We may experience
difficulties, delays or unexpected costs and not achieve
anticipated benefits and savings from our recently announced
restructuring plans. 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 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, 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 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 risks associated with acquisition
transactions; 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 Quarterly Report on Form
10-Q for the quarter ended June 30,
2015 (such periodic public filings having been filed under
the "Actavis plc" name) and from time to time in Allergan's other
investor communications . Except as expressly required by law,
Allergan disclaims any intent or obligation to update these
forward-looking statements.
Avastin® is 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.
Lisa Defrancesco, 862-261-7152
(investors)
Mark Marmur, 862-261-7558
(media)
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