THOUSAND OAKS, Calif. and
DUBLIN, Sept. 9, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN)
and Allergan plc. (NYSE:AGN) today announced data from a Phase 3
study evaluating the efficacy and safety of ABP 980, a
Herceptin® (trastuzumab) biosimilar, compared with the
originator product in patients with human epidermal growth factor
receptor 2-positive (HER2-positive) early breast cancer. Results
from the neoadjuvant efficacy phase of the study, including
pathologic complete response assessed both by local investigators
and also by independent pathology review, were presented today
during a poster discussion at the European Society for Medical
Oncology (ESMO) 2017 Congress. Efficacy, safety and immunogenicity
data support ABP 980 as a trastuzumab biosimilar and add to the
totality of evidence currently under review by the European
Medicines Agency (EMA) and the U.S. Food and Drug Administration
(FDA).
"Biosimilars have the potential to provide more patients access
to high-quality therapies with proven safety and efficacy
profiles," said Serafin Morales,
M.D., medical oncologist, University Hospital Arnau de Vilanova,
Lleida, Spain. "The results
presented today add to the data package demonstrating similarity
between ABP 980 and trastuzumab."
The co-primary endpoints of the study were risk difference (RD)
and risk ratio (RR) of pathologic complete response in breast
tissue and axillary lymph nodes, and the prespecified equivalence
margins were +/-13 percent for RD and 0.759 to 1.318 for RR.
According to local review, 48 percent and 40.5 percent of patients
in the ABP 980 arm and trastuzumab arm, respectively, achieved
pathologic complete response. RD and RR of pathologic complete
response were 7.3 percent (90 percent CI: 1.2, 13.4) and 1.19 (90
percent CI: 1.033, 1.366) respectively. Based on central
independent review, which was conducted as part of a sensitivity
analysis, 47.8 percent and 41.8 percent in the ABP 980 arm and
trastuzumab arm, respectively, achieved pathologic complete
response. RD and RR of pathologic complete response respectively
were 5.8 percent (90 percent CI: -0.5, 12.0) and 1.14 (90 percent
CI: 0.993, 1.312).
Frequency, type and severity of adverse events were similar
between ABP 980 and trastuzumab. No new safety signals compared to
the known safety profile of trastuzumab were detected.
"At the heart of Amgen's commitment to biosimilars is our
mission to serve patients. We are leveraging our more than 35 years
of biotechnology experience and using the same personnel, services
and manufacturing expertise from the company's innovative business
to produce high-quality, reliably supplied biosimilars for some of
the most complex diseases," said Sean E.
Harper, M.D., executive vice president of Research and
Development at Amgen. "The results presented today reinforce the
potential of ABP 980 for breast cancer patients, and we look
forward to continued discussions with regulatory authorities."
"Allergan is proud to be collaborating with Amgen on the
development of several oncology biosimilars that require
significant expertise, infrastructure and investment to ensure safe
therapies for patients," said David
Nicholson, Ph.D., chief research and development officer,
Allergan. "We are excited about the progress of ABP 980 and are
committed to its development in hopes of providing patients with an
effective alternative option."
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 of which has been approved
by the FDA and European authorities.
ABP 980 Phase 3 Study Design
The ABP 980 Phase 3 LILAC
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 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 either ABP 980 or trastuzumab in the neoadjuvant
phase, and pathologic complete response was analyzed.
In the adjuvant phase, following surgery, patients received ABP
980 or trastuzumab Q3W for up to one year from the first day either
product was 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 either underwent a single
switch to ABP 980 or continued on trastuzumab Q3W for the adjuvant
phase. The allocation to a treatment group during the neoadjuvant
or adjuvant phase occurred by randomization, as did the single
switch from trastuzumab to ABP 980 after the neoadjuvant phase.
The primary analysis was conducted when the last patient
completed the surgery following the neoadjuvant therapy.
Statistical equivalence was assessed by comparing the confidence
interval of the RD and RR of the pathologic complete response in
breast tissue and axillary lymph nodes with the prespecified
equivalence margins.
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
most common cancer in Europe for
females, and the most common cancer overall, with more than 464,000
new cases diagnosed each year.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, 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
strength as trastuzumab. In March and July of 2017 respectively,
Amgen and Allergan submitted a Marketing Authorization
Application to the EMA and a Biologics License Application to
the FDA for ABP 980.
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.
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.
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, including our devices,
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. 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 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.
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 FDA, and no
conclusions can or should be drawn regarding the safety or
effectiveness of the product candidates.
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.
Lisa Defrancesco, 862-261-7152
(investors)
Mark Marmur, 862-261-7558
(media)
References:
- Mayo Clinic. HER2-Positive Breast Cancer: What is it?
http://www.mayoclinic.org/breast-cancer/expert-answers/faq-20058066.
Accessed August 2, 2017.
- American Cancer Society. Targeted therapy for breast cancer.
http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-treating-targeted-therapy.
Accessed August 2, 2017.
- Cancer Research UK. Breast cancer incidence (invasive)
statistics.
http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/breast-cancer/incidence-invasive#heading-Eleven.
Accessed August 2, 2017.
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