THOUSAND OAKS, Calif.,
July 18, 2019 /PRNewswire/
-- Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today
announced that MVASI™ (bevacizumab-awwb), a biosimilar to
Avastin® (bevacizumab), and KANJINTITM
(trastuzumab-anns), a biosimilar to Herceptin®
(trastuzumab), are now available in the
United States (U.S.).
MVASI, the first oncology therapeutic biosimilar approved by
the U.S. Food and Drug Administration (FDA), is
approved for the treatment of five types of cancer: in combination
with chemotherapy for metastatic colorectal cancer (mCRC); in
combination with chemotherapy for non-squamous non-small cell lung
cancer (NSCLC); recurrent glioblastoma; in combination with
interferon-alfa for metastatic renal cell carcinoma; and in
combination with chemotherapy for persistent, recurrent, or
metastatic cervical cancer.
KANJINTI is FDA approved for all approved indications of
Herceptin: for the treatment of HER2-overexpressing adjuvant and
metastatic breast cancer and HER2-overexpressing metastatic gastric
or gastroesophageal junction adenocarcinoma.
"The introduction of biosimilars is an important step in
increasing options for treating HER2-positive breast cancers, which
account for about 25% of all breast cancers," said Paula Schneider, chief executive officer, Susan
G. Komen Breast Cancer Foundation. "As patient advocates, we are
working to ensure that patients are educated about biosimilars and
understand that these FDA-approved treatments are just as effective
as the original biologic drugs."
The Wholesale Acquisition Cost (WAC or "list price") of both
MVASI and KANJINTI will be 15% lower than their reference
products. MVASI is being made available at a WAC of
$677.40 per 100 mg and $2,709.60 per 400 mg single-dose vial, 15% less
than the WAC for Avastin. KANJINTI is being made available at
a WAC of $3,697.26 per 420 mg
multi-dose vial, 15% below the WAC of Herceptin. At launch, MVASI
is priced 12% below the current Avastin Average Selling Price (ASP)
and KANJINTI is priced 13% below the current Herceptin ASP. Both
products will be available from both wholesalers and specialty
distributors.
"Several years ago, Amgen made the strategic decision to invest
in building a global biosimilars business, leveraging our nearly
four decades of experience in developing and manufacturing
best-in-class biologics," said Murdo
Gordon, executive vice president of Global Commercial
Operations at Amgen. "Following several recent launches in
Europe, we are excited to be
launching our first two biosimilars in the U.S., which will provide
for immediate savings for Medicare patients and commercial
payers. We have several more biosimilars advancing through our
pipeline, even as we continue to drive innovation through novel
therapies for cancer and other serious diseases."
The WAC price measure does not account for discounts and rebates
and may be significantly higher than out-of-pocket cost for
patients, which can vary depending on several factors. Medicare and
commercial insurance, for example, will generally pay for MVASI and
KANJINTI based on ASP rather than WAC. Out-of-pocket cost may also
depend on and be reduced by additional factors, including
eligibility for patient assistance.
Actual costs to patients and providers for MVASI and KANJINTI
are anticipated to be lower than WAC as WAC does not reflect
discounts or rebates. Out-of-pocket costs to patients will vary
depending on insurance status and eligibility for patient
assistance. MVASI and KANJINTI will be available from both
wholesalers and specialty distributors.
"As the first products from our collaboration with Amgen to be
launched in the U.S., MVASI and KANJINTI reinforce our ongoing
dedication to providing patients with additional treatment
options," said David Nicholson,
chief research and development officer at Allergan. "We are excited
about the progress we've made through this partnership and look
forward to continued milestones together with our remaining
biosimilar products."
Amgen and Allergan are committed to developing high-quality
biosimilars supported by robust analytical and clinical packages.
MVASI and KANJINTI were proven to be highly similar to, and to have
no clinically meaningful differences in terms of safety and
effectiveness from Avastin and Herceptin, respectively, based on a
totality of evidence, which included comparative analytical,
clinical safety and efficacy data. At the time of FDA
approval, KANJINTI was the only trastuzumab biosimilar to
incorporate the evaluation of a single transition in the clinical
study, in which a portion of patients who began the study on
Herceptin made a single transition to KANJINTI. This portion of the
study demonstrated similar safety and immunogenicity in patients on
KANJINTI who were previously on Herceptin.
Amgen has a total of 10 biosimilars in its portfolio, three of
which have been approved in the U.S.
About MVASI™ (bevacizumab-awwb) in the U.S.
MVASI is a
recombinant humanized monoclonal IgG1 antibody that binds VEGF and
prevents the interaction of VEGF to its receptors (Flt-1 and KDR)
on the surface of endothelial cells. The interaction of VEGF with
its receptors leads to endothelial cell proliferation and new blood
vessel formation in in vitro models of angiogenesis.
Administration of bevacizumab to xenotransplant models of colon
cancer in nude (athymic) mice caused reduction of microvascular
growth and inhibition of metastatic disease progression.
MVASI, in combination with intravenous fluorouracil-based
chemotherapy, is indicated for the first- or second-line treatment
of patients with metastatic colorectal cancer (mCRC).
MVASI, in combination with fluoropyrimidine- irinotecan- or
fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for
the second-line treatment of patients with mCRC who have progressed
on a first-line bevacizumab-containing regimen.
Limitations of Use: MVASI is not indicated for adjuvant
treatment of colon cancer.
MVASI, in combination with carboplatin and paclitaxel, is
indicated for the first line treatment of patients with
unresectable, locally advanced, recurrent or metastatic
non-squamous non-small cell lung cancer (NSCLC).
MVASI is indicated for the treatment of recurrent glioblastoma
(GBM) in adults.
MVAS, in combination with interferon-alfa, is indicated for the
treatment of metastatic renal cell carcinoma (mRCC).
MVASI, in combination with paclitaxel and cisplatin or
paclitaxel and topotecan, is indicated for the treatment of
patients with persistent, recurrent, or metastatic cervical
cancer.
MVASI (bevacizumab-awwb) Professional Important Safety
Information
Gastrointestinal (GI) perforation
- Serious and sometimes fatal GI perforation occurred at a higher
incidence in bevacizumab-treated patients compared to patients
treated with chemotherapy
- The incidence of GI perforation ranged from 0.3% to 3% across
clinical studies
- Discontinue MVASITM in patients with GI
perforation
Surgery and wound healing complications
- The incidence of wound healing and surgical complications,
including serious and fatal complications, is increased in
bevacizumab-treated patients
- Withhold MVASITM for at least 28 days prior to
elective surgery. Do not administer MVASITM for at least
28 days after surgery and until the wound is fully healed
- Discontinue in patients with wound healing complications
requiring medical intervention
Hemorrhage
- Severe or fatal hemorrhage, including hemoptysis, GI bleeding,
hematemesis, central nervous system hemorrhage, epistaxis, and
vaginal bleeding, occurred up to 5-fold more frequently in patients
receiving bevacizumab. In clinical studies, the incidence of grade
≥3 hemorrhagic events among patients receiving bevacizumab ranged
from 0.4% to 7%
- Do not administer MVASITM to patients with serious
hemorrhage or a recent history of hemoptysis (≥1/2 tsp of red
blood)
- Discontinue MVASITM in patients who develop grade
3-4 hemorrhage
Additional serious and sometimes fatal adverse events with
increased incidence in the bevacizumab-treated arm vs chemotherapy
arm included:
- Non-GI fistulae (<1% to 1.8%, highest in patients with
cervical cancer)
- Arterial thromboembolic events (grade ≥3, 5%, highest in
patients with GBM)
- Renal injury and proteinuria
-
- Grade 3-4 proteinuria ranged from 0.7% to 7% in clinical
studies
- Nephrotic syndrome (<1%)
Additional serious adverse events with increased incidence in
the bevacizumab-treated arm vs chemotherapy arm included:
- Venous thromboembolism (grade ≥3, 11% seen in GOG-0240)
- Hypertension (grade 3-4, 5%-18%)
- Posterior reversible encephalopathy syndrome (PRES)
(<0.5%)
- Congestive heart failure (CHF) (1%)
Infusion reactions with the first dose of bevacizumab occurred
in <3% of patients, and severe reactions occurred in 0.2% of
patients
Avoid use in patients with ovarian cancer who have evidence of
recto-sigmoid involvement by pelvic examination or bowel
involvement on CT scan or clinical symptoms of bowel
obstruction
Inform females of reproductive potential of the risk of ovarian
failure prior to initiating treatment with MVASITM
Pregnancy warning
- Based on the mechanism of action and animal studies,
MVASITM may cause fetal harm when administered to
pregnant women
- Advise female patients that MVASITM may cause fetal
harm, and to inform their healthcare provider of a known or
suspected pregnancy
- Advise females of reproductive potential to use effective
contraception during treatment with MVASITM and for 6
months after the last dose
- Advise nursing women that breastfeeding is not recommended
during treatment with MVASITM and for 6 months following
their last dose of treatment
- MVASITM may impair fertility
Most Common Adverse Events
- Across indications, the most common adverse reactions observed
in bevacizumab -treated patients at a rate of >10% were:
epistaxis, headache, hypertension, rhinitis, proteinuria, taste
alteration, dry skin, rectal hemorrhage, lacrimation disorder, back
pain, exfoliative dermatitis
- Across all studies, bevacizumab was discontinued in 8% to 22%
of patients because of adverse reactions
Indication-Specific Adverse Events
- In CC, grade 3 or 4 adverse reactions in Study GOG-0240,
occurring at a higher incidence (≥2%) in 218 patients receiving
bevacizumab plus chemotherapy compared to 222 patients receiving
chemotherapy alone, were abdominal pain (12% vs 10%), diarrhea (6%
vs 3%), anal fistula (4% vs 0%), proctalgia (3% vs 0%), urinary
tract infection (8% vs 6%), cellulitis (3% vs 0.5%), fatigue (14%
vs 10%), hypertension (11% vs 0.5%), thrombosis (8% vs 3%),
hypokalemia (7% vs 4%), hyponatremia (4% vs 1%), dehydration (4% vs
0.5%), neutropenia (8% vs 4%), lymphopenia (6% vs 3%), back pain
(6% vs 3%), and pelvic pain (6% vs 1%)
- In mRCC, the most common grade 3-5 adverse events in AVOREN,
occurring at a >2% higher incidence in bevacizumab-treated
patients vs controls, were fatigue (13% vs 8%), asthenia (10% vs
7%), proteinuria (7% vs 0%), hypertension (6% vs 1%, including
hypertension and hypertensive crisis), and hemorrhage (3% vs 0.3%;,
including epistaxis, small intestinal hemorrhage, aneurysm
ruptured, gastric ulcer hemorrhage, gingival bleeding, hemoptysis,
hemorrhage intracranial, large intestinal hemorrhage, respiratory
tract hemorrhage, and traumatic hematoma)
- In rGBM Study EORTC 26101, 22% of patients discontinued
treatment in the bevacizumab with lomustine arm due to adverse
reactions compared with 10% of patients in the lomustine arm. In
patients receiving bevacizumab with lomustine, the adverse reaction
profile was similar to that observed in other approved
indications
- In NSCLC, grade 3-5 (nonhematologic) and grade 4-5
(hematologic) adverse events in Study E4599 occurring at a ≥2%
higher incidence in bevacizumab-treated patients vs controls were
neutropenia (27% vs 17%), fatigue (16% vs 13%), hypertension (8% vs
0.7%), infection without neutropenia (7% vs 3%), venous
thromboembolism (5% vs 3%), febrile neutropenia (5% vs 2%),
pneumonitis/pulmonary infiltrates (5% vs 3%), infection with grade
3 or 4 neutropenia (4% vs 2%), hyponatremia (4% vs 1%), headache
(3% vs 1%), and proteinuria (3% vs 0%)
- In first-line mCRC, the most common grade 3-4 events in Study
2107, which occurred at a ≥2% higher incidence in the bevacizumab
plus IFL vs IFL groups, were asthenia (10% vs 7%), abdominal pain
(8% vs 5%), pain (8% vs 5%), hypertension (12% vs 2%), deep vein
thrombosis (9% vs 5%), intra-abdominal thrombosis (3% vs 1%),
syncope (3% vs 1%), diarrhea (34% vs 25%), constipation (4% vs 2%),
leukopenia (37% vs 31%), and neutropenia (21% vs 14%)
- In second-line mCRC, the most common grade 3-5 (nonhematologic)
and 4-5 (hematologic) events in Study E3200, which occurred at a
higher incidence (≥2%) in the bevacizumab plus FOLFOX4 vs FOLFOX4
groups, were fatigue (19% vs 13%), diarrhea (18% vs 13%), sensory
neuropathy (17% vs 9%), nausea (12% vs 5%), vomiting (11% vs 4%),
dehydration (10% vs 5%), hypertension (9% vs 2%), abdominal pain
(8% vs 5%), hemorrhage (5% vs 1%), other neurological (5% vs 3%),
ileus (4% vs 1%), and headache (3% vs 0%). These data are likely to
underestimate the true adverse event rates due to the reporting
mechanisms used in this study
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 full Prescribing Information at
www.Amgen.com.
About KANJINTITM (trastuzumab-anns) in the
U.S.
KANJINTI is a biosimilar to Herceptin, 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 Herceptin. KANJINTI has the same pharmaceutical dosage
form and same strength after reconstitution as Herceptin.
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
- As part of treatment 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
- Trastuzumab products administration 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 KANJINTITM. Discontinue
KANJINTITM treatment in patients receiving
adjuvant therapy and withhold KANJINTITM in patients
with metastatic disease for clinically significant decrease in left
ventricular function
Infusion Reactions; Pulmonary Toxicity
- Trastuzumab products administration can result in serious
and fatal infusion reactions and pulmonary toxicity. Symptoms
usually occur during or within 24 hours of administration.
Interrupt KANJINTITM infusion for dyspnea or clinically
significant hypotension. Monitor patients until symptoms completely
resolve. Discontinue KANJINTITM 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 products can cause left ventricular cardiac
dysfunction, arrhythmias, hypertension, disabling cardiac failure,
cardiomyopathy, and cardiac death
- Trastuzumab products can also cause asymptomatic decline in
left ventricular ejection fraction (LVEF)
- Discontinue KANJINTITM treatment in patients
receiving adjuvant breast cancer therapy and withhold
KANJINTITM 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 KANJINTITM
- 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 KANJINTITM treatment
- Monitor more frequently if KANJINTITM is withheld
for significant left ventricular cardiac dysfunction
Infusion Reactions
- KANJINTITM administration can result in serious
and fatal infusion reactions
- Symptoms usually occur during or within 24 hours of
KANJINTITM administration
- Interrupt KANJINTITM infusion for dyspnea or
clinically significant hypotension
- Monitor patients until symptoms completely resolve
- Discontinue KANJINTITM 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 KANJINTITM
- Advise pregnant women and females of reproductive potential
that exposure to KANJINTITM 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 KANJINTITM. 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 KANJINTITM
treatment and any potential adverse effects on the breastfed child
from KANJINTITM 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 KANJINTITM 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 full Prescribing Information, including Boxed
WARNINGS, at www.Amgen.com.
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 assumes 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 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, 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, 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
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'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 Amgen 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 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
products. 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. A breakdown, cyberattack or
information security breach could compromise the confidentiality,
integrity and availability of Amgen's systems and Amgen's data.
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. Amgen
may not be able to access the capital and credit markets on terms
that are favorable to it, or at all.
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 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® and Avastin® are
registered trademarks of Genentech, Inc.
CONTACT: Amgen, Thousand
Oaks
Kelley Davenport, 202-585-9637
(media)
Trish Hawkins, 805-447-5631
(media)
Arvind Sood, 805-447-1060
(investors)
CONTACT: Allergan plc.
Manisha Narasimhan, 862-261-7162
(investor relations)
Fran DeSena, 862-261-8820 (media
relations)
View original content to download
multimedia:http://www.prnewswire.com/news-releases/amgen-and-allergans-mvasi-bevacizumab-awwb-and-kanjinti-trastuzumab-anns-now-available-in-the-united-states-300887871.html
SOURCE Amgen