THOUSAND OAKS, Calif. and
DUBLIN, July 21, 2016 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today announced results
from a Phase 3 study evaluating efficacy and safety of ABP 980
compared with trastuzumab in patients with human epidermal growth
factor receptor 2-positive (HER2-positive) early breast cancer. The
results ruled out inferiority compared to trastuzumab but could not
rule out superiority based on its primary efficacy endpoint of the
difference of the percentage of patients with a pathologic complete
response (pCR). The primary endpoint had a prespecified equivalence
margin of +/- 13 percent and the observed upper end of the
confidence interval was 13.4 percent.
Overall, adverse events were comparable between ABP 980 and
trastuzumab. In the neoadjuvant phase of the study, which included
chemotherapy, there were more serious adverse events reported in
the ABP 980 group, the majority of which were reported by the
investigators as unlikely related to investigational product. In
the adjuvant phase of the study, which did not include
chemotherapy, serious adverse events were comparable between
treatment groups. The overall results also showed comparable
immunogenicity.
"We believe this study confirms no clinically meaningful
differences between ABP 980 and trastuzumab, and we look forward to
continued discussions with regulatory authorities," said
Sean E. Harper, M.D., executive vice
president of Research and Development at Amgen. "Biosimilars are
approved based on the analytical, nonclinical and clinical data,
and we believe that the totality of the evidence we've generated
supports ABP 980 as highly similar to the reference product."
"These results provide significant clinical evidence that ABP
980 could be an important biosimilar treatment option for patients
with HER2-positive early breast cancer," said David Nicholson, chief research and development
officer, Allergan. "Allergan is committed to the continued
development of ABP 980 and other biosimilars that provide safe,
high-quality and effective therapies in key disease areas."
ABP 980 is being developed as a biosimilar to trastuzumab, a
recombinant DNA-derived humanized monoclonal immunoglobulin G1
kappa antibody which targets HER2. Trastuzumab is approved in many
regions for the treatment of HER2-positive early breast cancer,
metastatic breast cancer and metastatic gastric cancer.
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 above referenced Phase 3 study was a
randomized, multicenter, double-blinded, active-controlled study
(study number 20120283) that evaluated safety and efficacy of ABP
980 compared to trastuzumab in adult female patients with
HER2-positive early breast cancer. There were 725 patients
randomized, with 364 patients in the ABP 980 group and 361 patients
in the trastuzumab group.
In the neoadjuvant phase, enrolled patients received run-in
chemotherapy consisting of epirubicin and cyclophosphamide (EC)
every three weeks (Q3W) for four cycles. Once run-in chemotherapy
was completed, patients with adequate cardiac function were
randomized 1:1 to receive investigational product (ABP 980 or
trastuzumab), plus paclitaxel, Q3W for four cycles. Surgery (breast
and sentinel node or axillary lymph node resection) was complete
three to seven weeks after the last dose of investigational product
in the neoadjuvant phase, and pCR was analyzed.
In the adjuvant phase, following surgery, patients received
investigational product (ABP 980 or trastuzumab) Q3W for up to one
year from the first day of investigational product administered in
the neoadjuvant phase. Patients who received ABP 980 during the
neoadjuvant phase continued to receive ABP 980 Q3W for the adjuvant
phase. Patients who received trastuzumab during the neoadjuvant
phase received either ABP 980 or trastuzumab Q3W for the adjuvant
phase. The allocation to a treatment group during the neoadjuvant
or adjuvant phase occurred at randomization.
The primary analysis was conducted when the last patient
completed the surgery following the neoadjuvant therapy. Clinical
equivalence was assessed by comparing the confidence interval of
the risk difference and risk ratio of the pCR in breast tissue and
axillary lymph nodes with the prespecified equivalence margins. The
final analysis of safety will be conducted when the last patient
has completed their last study assessment in the adjuvant
phase.
About HER2-Positive Early Breast Cancer
HER2-positive
early breast cancer is a breast cancer that tests positive for a
protein called human epidermal growth factor receptor 2 (HER2),
which promotes the growth of cancer cells.1
Approximately 20 percent of all breast cancers are
HER2-positive.2 Breast cancer is the second leading
cause of cancer death among women and each year it is estimated
that over 230,000 women in the United
States will be diagnosed.3 HER2-positive breast
cancers tend to grow and spread more aggressively than
HER2-negative breast cancers.1
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, metastatic breast cancer and metastatic gastric cancer. The
active ingredient of ABP 980 is a humanized monoclonal antibody
which has the same amino acid sequence as trastuzumab. ABP 980 has
the same pharmaceutical dosage form and strength as trastuzumab
(US) and trastuzumab (EU).
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 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 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
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 and follow us on https://twitter.com/allergan.
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 our 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 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 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. 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. 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
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. 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. 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 acquire other companies or products and to integrate
the operations of companies we have acquired may not be successful.
We may not be able to access the capital and credit markets on
terms that are favorable to us, or at all. We are increasingly
dependent on information technology systems, infrastructure and
data security. 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.
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 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
March 31, 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.
Herceptin® 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
Fran DeSena, 973-517-3132
(media)
Mark Marmur, 862-261-7558
(media)
Lisa DeFrancesco, 862-261-7152
(investors)
References:
1. Mayo Clinic. HER2-Positive Breast Cancer: What is it?
http://www.mayoclinic.org/breast-cancer/expert-answers/faq-20058066.
Last updated 2015. Accessed on July 1,
2016.
2. American Cancer Society. Targeted therapy for breast cancer.
http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-treating-targeted-therapy.
Last updated 2016. Accessed on July
2, 16.
3. National Breast Cancer Foundation, Inc. Breast Cancer Facts.
http://www.nationalbreastcancer.org/breast-cancer-facts. Last
updated 2015. Accessed on July 2,
2016.
Logo - http://photos.prnewswire.com/prnh/20081015/AMGENLOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/amgen-and-allergan-announce-top-line-results-from-phase-3-study-evaluating-abp-980-compared-with-trastuzumab-in-patients-with-human-epidermal-growth-factor-receptor-2-positive-early-breast-cancer-300301923.html
SOURCE Amgen