THOUSAND OAKS, Calif.,
June 13, 2019 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today announced that the
U.S. Food and Drug Administration (FDA) has approved
KANJINTI™ (trastuzumab-anns) for all approved
indications of the reference product, Herceptin®
(trastuzumab): for the treatment of HER2-overexpressing
adjuvant and metastatic breast cancer and HER2-overexpressing
metastatic gastric or gastroesophageal junction adenocarcinoma.
"The FDA approval of KANJINTI is an important milestone for our
biosimilars portfolio, providing an additional treatment option for
patients across three types of cancer," said David M. Reese, M.D., executive vice president
of Research and Development at Amgen. "KANJINTI is the third
biosimilar from our portfolio to receive FDA approval, highlighting
our long-term commitment to providing patients with serious
illnesses access to high-quality biological therapies."
KANJINTI was proven to be highly similar to, and to have no
clinically meaningful differences from, Herceptin based on a
comprehensive totality of evidence which included extensive
comparative analytical, pharmacokinetic and clinical data. At
the time of approval, KANJINTI is the only trastuzumab biosimilar
to incorporate the evaluation of a single transition in the
clinical study, demonstrating similar safety and immunogenicity in
patients who were previously on Herceptin.
"KANJINTI is the second of four biosimilars from Amgen and
Allergan's collaboration to be approved by the FDA," said
David Nicholson, chief research and
development officer at Allergan. "We are proud of the progress
being made as we continuously strive to develop and deliver
high-quality cancer therapies in collaboration with Amgen."
Amgen has a total of 10 biosimilars in its portfolio, three of
which have been approved in the U.S. and three that are approved in
the European Union (EU).
About KANJINTI™ (trastuzumab-anns) in the
U.S.
KANJINTI is a biosimilar to trastuzumab, a recombinant DNA-derived
humanized monoclonal immunoglobulin G1 kappa antibody. The active
ingredient of KANJINTI is a humanized monoclonal antibody that has
the same amino acid sequence, structure and function as
trastuzumab. KANJINTI has the same pharmaceutical dosage form and
same strength after reconstitution as trastuzumab.
KANJINTI is currently not available commercially. This is
not an offer for sale. The following information is derived
from the approved label in the U.S.
In the U.S., KANJINTI is approved for:
Adjuvant Breast Cancer
KANJINTI is indicated for adjuvant treatment of HER2-overexpressing
node-positive or node-negative (ER/PR-negative or with one
high-risk feature*) breast cancer:
- As part of a treatment regimen containing doxorubicin,
cyclophosphamide and either paclitaxel or docetaxel
- With docetaxel and carboplatin
- As a single agent following multi-modality anthracycline-based
therapy
Select patients for therapy based on an FDA-approved companion
diagnostic for a trastuzumab product.
* High-risk is defined as ER/PR positive with one of the
following features: tumor size >2 cm, age <35 years, or tumor
grade 2 or 3.
Metastatic Breast Cancer
KANJINTI is indicated:
- In combination with paclitaxel for the first line treatment of
HER2-overexpressing metastatic breast cancer
- As a single agent for treatment of HER2-overexpressing breast
cancer in patients who have received one or more chemotherapy
regimens for metastatic disease
Select patients for therapy based on an FDA-approved companion
diagnostic for a trastuzumab product.
Metastatic Gastric Cancer
KANJINTI is indicated, in combination with cisplatin and
capecitabine or 5-fluorouracil, for the treatment of patients with
HER2-overexpressing metastatic gastric or gastroesophageal junction
adenocarcinoma, who have not received prior treatment for
metastatic disease.
Select patients for therapy based on an FDA-approved companion
diagnostic for a trastuzumab product.
KANJINTI U.S. Boxed WARNINGS and Important Safety
Information
Boxed WARNINGS and Additional Important Safety
Information
Cardiomyopathy
- Administration of trastuzumab products can result in
sub-clinical and clinical cardiac failure. The incidence and
severity was highest in patients receiving trastuzumab with
anthracycline-containing chemotherapy regimens
- Evaluate left ventricular function in all patients prior to
and during treatment with KANJINTI™. Discontinue
KANJINTI™ treatment in patients receiving
adjuvant therapy and withhold KANJINTI™ in patients
with metastatic disease for clinically significant decrease in left
ventricular function
Infusion Reactions; Pulmonary Toxicity
- Administration of trastuzumab products can result in serious
and fatal infusion reactions and pulmonary toxicity. Symptoms
usually occur during or within 24 hours of administration.
Interrupt KANJINTI™ infusion for dyspnea or clinically
significant hypotension. Monitor patients until symptoms completely
resolve. Discontinue KANJINTI™ for anaphylaxis,
angioedema, interstitial pneumonitis, or acute respiratory distress
syndrome
Embryo-Fetal Toxicity
- Exposure to trastuzumab products during pregnancy can result
in oligohydramnios and oligohydramnios sequence manifesting as
pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
Advise patients of these risks and the need for effective
contraception
Cardiomyopathy
- Administration of trastuzumab products can result in
sub-clinical and clinical cardiac failure. The incidence and
severity was highest in patients receiving trastuzumab with
anthracycline-containing chemotherapy regimens. In a pivotal
adjuvant breast cancer trial, one patient who developed CHF died of
cardiomyopathy
- Trastuzumab can cause left ventricular cardiac dysfunction,
arrhythmias, hypertension, disabling cardiac failure,
cardiomyopathy, and cardiac death
- Trastuzumab can also cause asymptomatic decline in LVEF
- Discontinue KANJINTI™ treatment in patients
receiving adjuvant breast cancer therapy and withhold
KANJINTI™ in patients with metastatic disease for
clinically significant decrease in left ventricular function
Cardiac Monitoring
- Evaluate cardiac function prior to and during treatment. For
adjuvant breast cancer therapy, also evaluate cardiac function
after completion of KANJINTI™
- Conduct thorough cardiac assessment, including history,
physical examination, and determination of LVEF by echocardiogram
or MUGA scan
- Monitor frequently for decreased left ventricular function
during and after KANJINTI™ treatment
- Monitor more frequently if KANJINTI™ is
withheld for significant left ventricular cardiac dysfunction
Infusion Reactions
- KANJINTI™ administration can result in serious
and fatal infusion reactions
- Symptoms usually occur during or within 24 hours of
KANJINTI™ administration
- Interrupt KANJINTI™ infusion for dyspnea or
clinically significant hypotension
- Monitor patients until symptoms completely resolve
- Discontinue KANJINTI™ for infusion
reactions manifesting as anaphylaxis, angioedema, interstitial
pneumonitis, or acute respiratory distress syndrome. Strongly
consider permanent discontinuation in all patients with severe
infusion reactions
- Infusion reactions consist of a symptom complex characterized
by fever and chills, and on occasion include nausea, vomiting, pain
(in some cases at tumor sites), headache, dizziness, dyspnea,
hypotension, rash, and asthenia
Embryo-Fetal Toxicity
- Exposure to trastuzumab products during pregnancy can result
in oligohydramnios and oligohydramnios sequence manifesting as
pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
Advise patients of these risks and the need for effective
contraception
- Verify the pregnancy status of females of reproductive
potential prior to the initiation of KANJINTI™
- Advise pregnant women and females of reproductive potential
that exposure to KANJINTI™ during pregnancy or within
7 months prior to conception can result in fetal harm
- Advise females of reproductive potential to use effective
contraception during treatment and for at least 7 months following
the last dose of KANJINTI™. Advise female patients to
contact their healthcare provider with a known or suspected
pregnancy
- Consider the developmental and health benefits of breastfeeding
along with the mother's clinical need for KANJINTI™
treatment and any potential adverse effects on the breastfed child
from KANJINTI™ or from the underlying maternal
condition
Pulmonary Toxicity
- Trastuzumab products can result in serious and fatal
pulmonary toxicity, which includes dyspnea, interstitial
pneumonitis, pulmonary infiltrates, pleural effusions,
noncardiogenic pulmonary edema, pulmonary insufficiency and
hypoxia, acute respiratory distress syndrome, and pulmonary
fibrosis. Such events can occur as sequelae of infusion
reactions
- Patients with symptomatic intrinsic lung disease or with
extensive tumor involvement of the lungs, resulting in dyspnea at
rest, appear to have more severe toxicity
- Discontinue KANJINTI™ in patients experiencing
pulmonary toxicity
Exacerbation of Chemotherapy-Induced Neutropenia
- In randomized, controlled clinical trials, the per-patient
incidences of NCI-CTC Grade 3-4 neutropenia and of febrile
neutropenia were higher in patients receiving trastuzumab in
combination with myelosuppressive chemotherapy as compared to those
who received chemotherapy alone. The incidence of septic death was
similar among patients who received trastuzumab and those who did
not
Most Common Adverse Reactions
- The most common adverse reactions associated with trastuzumab
products in breast cancer were fever, nausea, vomiting, infusion
reactions, diarrhea, infections, increased cough, headache,
fatigue, dyspnea, rash, neutropenia, anemia, and myalgia
- The most common adverse reactions associated with trastuzumab
products in metastatic gastric cancer were neutropenia, diarrhea,
fatigue, anemia, stomatitis, weight loss, upper respiratory tract
infections, fever, thrombocytopenia, mucosal inflammation,
nasopharyngitis, and dysgeusia
You may report side effects to the FDA at (800) FDA-1088
or www.fda.gov/medwatch. You may also report side
effects to Amgen at 1-800-772-6436.
Please see additional select Important Safety Information
throughout, and the accompanying full Prescribing
Information, including Boxed WARNINGS.
Please see the accompanying full Prescribing Information,
including Boxed WARNINGS.
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 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 Oncology
Amgen Oncology is
searching for and finding answers to incredibly complex questions
that will advance care and improve lives for cancer patients and
their families. Our research drives us to understand the disease in
the context of the patient's life – not just their cancer journey –
so they can take control of their lives.
For the last four decades, we have been dedicated
to discovering the firsts that matter in oncology and to finding
ways to reduce the burden of cancer. Building on our heritage,
Amgen continues to advance the largest pipeline in the Company's
history, moving with great speed to advance those innovations for
the patients who need them.
At Amgen, we are driven by our commitment to
transform the lives of cancer patients and keep them at the center
of everything we do.
For more information, follow us on
www.twitter.com/amgenoncology.
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 leader. Allergan is focused on developing,
manufacturing and commercializing branded pharmaceutical, device,
biologic, surgical and regenerative medicine products for patients
around the world.
Allergan markets a portfolio of leading brands and best-in-class
products primarily focused on four key therapeutic areas including
central nervous system, eye care, medical aesthetics and
gastroenterology.
Allergan is an industry leader in Open Science, a model of
research and development, which defines our approach to identifying
and developing game-changing ideas and innovation for better
patient care. With this approach, Allergan has built one of the
broadest development pipelines in the pharmaceutical industry.
Allergan's success is powered by our 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,
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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,
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derived from relationships may be subject to disputes between the
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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
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affected by pricing pressure, political and public scrutiny and
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may be affected by regulatory, clinical and guideline developments
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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 facilities, including in Puerto Rico, 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. Amgen relies on collaborations with third
parties for the development of some of its product candidates and
for the commercialization and sales of some of its commercial
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respect to many of its marketed products as well as for the
discovery and development of new products. Further, some raw
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implicate an entire class of products could have a material adverse
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or products and to integrate the operations of companies Amgen has
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Amgen's stock price may be volatile and may be affected by a number
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Allergan plc Forward-Looking Statement
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; risks associated
with divestitures, acquisitions, mergers and joint ventures; risks
related to impairments; uncertainty associated with financial
projections, projected cost reductions, projected debt reduction,
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, 2018
and Allergan's Quarterly Report on Form 10-Q for the period ended
March 31, 2019. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements.
Herceptin® is registered trademark of Genentech,
Inc.
CONTACT: Amgen, Thousand
Oaks
Kelley Davenport, 202-585-9637
(media)
Kristen Davis, 805-447-3008
(media)
Arvind Sood, 805-447-1060
(investors)
CONTACT: Allergan plc.
Daphne Karydas, 862-261-8006
(investor relations)
Amy Rose, 862-261-7001 (media
relations)
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