− ICLUSIG Becomes the First and Only Targeted Treatment
Approved in the U.S. for Frontline Ph+ Acute Lymphoblastic Leukemia
(ALL) in Combination with Chemotherapy
− First FDA Approval in Ph+ ALL Based on Novel Primary
Endpoint of Minimal Residual Disease (MRD)-negative Complete
Remission (CR)
− Accelerated Approval Based on Data from the Phase 3
PhALLCON Trial, in which ICLUSIG Demonstrated Superiority in
MRD-negative Complete Remission Rates and Comparable Safety to
Imatinib
Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food
and Drug Administration (FDA) has approved the supplemental New
Drug Application (sNDA) for ICLUSIG® (ponatinib) for the treatment
of adult patients with newly diagnosed Philadelphia
chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in
combination with chemotherapy. This indication is approved under
accelerated approval based on minimal residual disease
(MRD)-negative complete remission (CR) at the end of induction.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in confirmatory
trials. This accelerated approval application was granted Priority
Review and evaluated under the Real-Time Oncology Review (RTOR)
program, an FDA initiative designed to expedite the delivery of
cancer medicines by allowing components of an application to be
reviewed before submission of the complete application.
“This label expansion for ICLUSIG is an incredibly exciting
milestone, allowing U.S. adult patients with newly diagnosed Ph+
ALL to have an approved, targeted treatment option in the
frontline,” said Awny Farajallah, MD, chief medical officer,
oncology at Takeda. “We are thrilled that the FDA has recognized
the potential of ICLUSIG to fill a large gap in care for these
patients and look forward to seeing the impact this can have on
people with this rare and aggressive form of cancer.”
The approval was supported by data from the PhALLCON study – the
first, global, Phase 3, registrational, head-to-head clinical trial
in adults with newly diagnosed Ph+ ALL. The study, in which
patients received either ICLUSIG or imatinib, plus
reduced-intensity chemotherapy, met its primary endpoint of
MRD-negative CR at the end of induction. MRD-negative CR is a
composite endpoint defined in alignment with the FDA that reflects
deep molecular and clinical responses and is an important
prognostic indicator for long-term outcomes for patients with Ph+
ALL. ICLUSIG demonstrated superiority compared to imatinib, with
patients who received ICLUSIG achieving a greater than two-fold
improvement in the rate of MRD-negative CR at the end of induction
(cycle 3). In the trial, the safety profile of ICLUSIG was
comparable to imatinib, and no new safety signals were
identified.
“Ph+ ALL is an extremely aggressive cancer and patients with
this disease suffer from poor outcomes. There has long been a need
for a potent TKI that can suppress mutation development and elicit
deep responses in the frontline,” said Elias Jabbour, MD, The
University of Texas MD Anderson Cancer Center and lead investigator
of the PhALLCON trial. “Ponatinib may help address these factors
and impact long-term outcomes.”
ICLUSIG is a kinase inhibitor indicated in the U.S. for adult
patients with newly diagnosed Ph+ ALL in combination with
chemotherapy. This indication is approved under accelerated
approval based on MRD-negative CR at the end of induction.
Continued approval for this indication may be contingent upon
verification of clinical benefit in a confirmatory trial(s). In
addition, it is approved as monotherapy in Ph+ ALL for whom no
other kinase inhibitors are indicated or T315I-positive Ph+ ALL,
chronic-phase (CP) CML with resistance or intolerance to at least
two prior kinase inhibitors, accelerated phase (AP) or blast phase
(BP) CML for whom no other kinase inhibitors are indicated or
T315I-positive CML (chronic phase, accelerated phase, or blast
phase). ICLUSIG is not indicated and is not recommended for the
treatment of patients with newly diagnosed CP-CML.
About the PhALLCON Trial The PhALLCON study is a Phase 3,
randomized, international, open-label multicenter trial evaluating
the efficacy and safety of ICLUSIG versus imatinib, in combination
with reduced-intensity chemotherapy as a frontline therapy for
adult patients with newly diagnosed Ph+ ALL.
A total of 245 patients were randomized 2:1 and treated with
ICLUSIG or imatinib plus reduced-intensity chemotherapy. The median
age of patients was 54 and 52 in the ICLUSIG and imatinib arms,
respectively. 164 patients were treated with ICLUSIG receiving a
starting dose of 30mg/day and 81 patients were treated with
imatinib at a starting dose of 600mg/day. All patients received
either ICLUSIG or imatinib with reduced-intensity chemotherapy
through induction, consolidation and maintenance phase. After
combination therapy, patients continued to receive single-agent
ICLUSIG or imatinib until relapse from CR, progressive disease
(PD), hematopoietic stem cell transplantation (HSCT), start of
alternative therapy or unacceptable toxicity. The primary endpoint
of the study was MRD-negative CR rate at the end of induction (3
cycles of treatment). Event-free survival, the key secondary
endpoint of the trial, is not yet mature.
About Philadelphia chromosome-positive acute lymphoblastic
leukemia (Ph+ ALL) Ph+ ALL is a rare form of ALL that affects
approximately 25% of adult ALL patients in the U.S. and is
characterized by the presence of an abnormal gene, known as the
Philadelphia chromosome. In patients who are Philadelphia
chromosome-positive (Ph+), an abnormal chromosome is formed when
pieces of chromosomes 9 and 22 switch with each other. This forms a
longer chromosome 9 and a shorter chromosome 22, which leads to the
development of BCR::ABL1 and is associated with Ph+ ALL.
About ICLUSIG® (ponatinib) tablets ICLUSIG is a kinase
inhibitor targeting BCR::ABL1, an abnormal tyrosine kinase that is
expressed in CML and Ph+ ALL. ICLUSIG is a targeted cancer medicine
developed using a computational and structure-based drug-design
platform, specifically designed to inhibit the activity of
BCR::ABL1 and its mutations. ICLUSIG inhibits native BCR::ABL1, as
well as all BCR::ABL1 treatment-resistant mutations, including the
most resistant T315I mutation. This mutation has been associated
with resistance to all other approved TKIs. ICLUSIG received full
approval from the FDA in November 2016. ICLUSIG is a kinase
inhibitor indicated in the U.S. for adult patients with newly
diagnosed Ph+ ALL in combination with chemotherapy. This indication
is approved under accelerated approval based on MRD-negative CR at
the end of induction. Continued approval for this indication may be
contingent upon verification of clinical benefit in a confirmatory
trial(s). In addition, it is approved as monotherapy in Ph+ ALL for
whom no other kinase inhibitors are indicated or T315I-positive Ph+
ALL, chronic-phase (CP) CML with resistance or intolerance to at
least two prior kinase inhibitors, accelerated phase (AP) or blast
phase (BP) CML for whom no other kinase inhibitors are indicated,
or T315I-positive CML (chronic phase, accelerated phase, or blast
phase). ICLUSIG is not indicated and is not recommended for the
treatment of patients with newly diagnosed CP-CML.
IMPORTANT SAFETY INFORMATION
WARNING: ARTERIAL OCCLUSIVE
EVENTS, VENOUS THROMBOEMBOLIC EVENTS, HEART FAILURE, and
HEPATOTOXICITY
See full prescribing
information for complete boxed warning.
- Arterial occlusive events (AOEs), including fatalities, have
occurred in ICLUSIG-treated patients. AOEs included fatal
myocardial infarction, stroke, stenosis of large arterial vessels
of the brain, severe peripheral vascular disease, and the need for
urgent revascularization procedures. Patients with and without
cardiovascular risk factors, including patients age 50 years or
younger, experienced these events. Monitor for evidence of AOEs.
Interrupt or discontinue ICLUSIG based on severity. Consider
benefit-risk to guide a decision to restart ICLUSIG.
- Venous thromboembolic events (VTEs) have occurred in
ICLUSIG-treated patients. Monitor for evidence of VTEs. Interrupt
or discontinue ICLUSIG based on severity.
- Heart failure, including fatalities, occurred in
ICLUSIG-treated patients. Monitor for heart failure and manage
patients as clinically indicated. Interrupt or discontinue ICLUSIG
for new or worsening heart failure.
- Hepatotoxicity, liver failure and death have occurred in
ICLUSIG-treated patients. Monitor liver function tests. Interrupt
or discontinue ICLUSIG based on severity.
WARNINGS AND PRECAUTIONS Arterial Occlusive Events
(AOEs): AOEs, including fatalities, have occurred in patients
who received ICLUSIG in PhALLCON, OPTIC and PACE. These included
cardiovascular, cerebrovascular, and peripheral vascular events. In
PhALLCON, 6% of 163 patients experienced AOEs; 3.7% experienced
Grade 3 or 4. The incidence of AOEs in OPTIC (45 mg-> 15 mg) was
14% of 94 patients; 6% experienced Grade 3 or 4. In PACE, the
incidence of AOEs was 26% of 449 patients; 14% experienced Grade 3
or 4. Fatal AOEs occurred in 0.6% of patients in PhALLCON, 2.1% of
patients in OPTIC, and in 2% of patients in PACE. Some patients in
PACE experienced recurrent or multisite vascular occlusion.
Patients with and without cardiovascular risk factors, including
patients age 50 years or younger, experienced these events.
The most common risk factors observed with these events in PACE
were history of hypertension, hypercholesterolemia, and
non-ischemic cardiac disease. In PhALLCON, OPTIC and PACE, AOEs
were more frequent with increasing age.
In PhALLCON, patients with uncontrolled hypertension,
hypertriglyceridemia, or diabetes were excluded. Patients with
clinically significant, uncontrolled, or active cardiovascular
disease, including any history of myocardial infarction, peripheral
vascular infarction, revascularization procedure, venous
thromboembolism, clinically significant atrial/ventricular
tachyarrhythmias, unstable angina, or congestive heart failure
within the 6 months prior to the first dose of ICLUSIG, were also
excluded.
In OPTIC, patients with uncontrolled hypertension or diabetes
and patients with clinically significant, uncontrolled, or active
cardiovascular disease were excluded.
In PACE, patients with uncontrolled hypertriglyceridemia and
patients with clinically significant or active cardiovascular
disease within the 3 months prior to the first dose of ICLUSIG were
excluded.
Consider whether the benefits of ICLUSIG are expected to exceed
the risks. Monitor for evidence of AOEs. Interrupt, then resume at
the same or decreased dose or discontinue ICLUSIG based on
recurrence/severity. Consider benefit-risk to guide a decision to
restart ICLUSIG.
Venous Thromboembolic Events (VTEs): Serious or severe
VTEs have occurred in patients who received ICLUSIG. In PhALLCON,
VTEs occurred in 12% of 163 patients, including serious or severe
(Grade 3 or 4) in 3.1% of patients. One of 94 patients in OPTIC
experienced a VTE (Grade 1 retinal vein occlusion). In PACE, VTEs
occurred in 6% of 449 patients including serious or severe (Grade 3
or 4) VTEs in 5.8% of patients. In PhALLCON and PACE VTEs included
deep venous thrombosis, embolism, pulmonary embolism, superficial
vein thrombosis, thrombosis, jugular vein thrombosis, superficial
thrombophlebitis, retinal vein occlusion, and retinal vein
thrombosis with vision loss. The incidence of VTEs in PACE was
higher in patients with Ph+ ALL (9% of 32 patients) and BP-CML (10%
of 62 patients). Monitor for evidence of VTEs. Interrupt, then
resume at the same or decreased dose or discontinue ICLUSIG based
on recurrence/severity.
Heart Failure: Fatal, serious or severe heart failure
events have occurred in patients who received ICLUSIG. In
PhALLCON, heart failure occurred in 6% of 163 patients; 1.2%
experienced serious or severe (Grade 3 or 4) heart failure. Heart
failure occurred in 13% of 94 patients in OPTIC; 1.1% experienced
serious or severe (Grade 3 or 4). In PACE, heart failure occurred
in 9% of 449 patients; 7% experienced serious or severe (Grade 3 or
higher). In PhALLCON the most frequently reported heart failure
event (>1 patient) was increased brain natriuretic peptide (BNP)
(2.5%). In OPTIC, the most frequently reported heart failure events
(>1 patient each) were left ventricular hypertrophy (3.2%) and
BNP increased (3.2%). In PACE, the most frequently reported heart
failure events (≥2%) were congestive cardiac failure (3.1%),
decreased ejection fraction (2.9%), and cardiac failure (2%).
Monitor patients for signs or symptoms consistent with heart
failure and manage heart failure as clinically indicated.
Interrupt, then resume at reduced dose or discontinue ICLUSIG for
new or worsening heart failure.
Hepatotoxicity: ICLUSIG can cause hepatotoxicity,
including liver failure and death. Fulminant hepatic failure
leading to death occurred in 3 patients, with hepatic failure
occurring within 1 week of starting ICLUSIG in one of these
patients. These fatal cases occurred in patients with BP-CML or Ph+
ALL treated with monotherapy. Hepatotoxicity occurred in 66% of 163
patients in PhALLCON, in 28% of 94 patients in OPTIC and in 32% of
449 patients in PACE. Grade 3 or 4 hepatotoxicity occurred in
PhALLCON (30% of 163 patients), in OPTIC (6% of 94 patients), and
in PACE (13% of 449 patients). The most frequent hepatotoxic events
were elevations of ALT, AST, GGT, bilirubin, and alkaline
phosphatase. Monitor liver function tests at baseline, then at
least monthly or as clinically indicated. Interrupt, then resume at
a reduced dose or discontinue ICLUSIG based on
recurrence/severity.
Hypertension: Serious or severe hypertension, including
hypertensive crisis, has occurred in patients who received ICLUSIG.
Patients may require urgent clinical intervention for hypertension
associated with confusion, headache, chest pain, or shortness of
breath. Monitor blood pressure at baseline and as clinically
indicated and manage hypertension as clinically indicated.
Interrupt, dose reduce, or stop ICLUSIG if hypertension is not
medically controlled. For significant worsening, labile or
treatment-resistant hypertension, interrupt ICLUSIG and consider
evaluating for renal artery stenosis.
Pancreatitis: Serious or severe pancreatitis has occurred
in patients who received ICLUSIG. Elevations of lipase and amylase
also occurred. In the majority of cases that led to dose
modification or treatment discontinuation, pancreatitis resolved
within 2-3 weeks. Monitor serum lipase every 2 weeks for the first
2 months and then monthly thereafter or as clinically indicated.
Consider additional serum lipase monitoring in patients with a
history of pancreatitis or alcohol abuse. Interrupt, then resume at
the same or reduced dose or discontinue ICLUSIG based on severity.
Evaluate for pancreatitis when lipase elevation is accompanied by
abdominal symptoms.
Increased Toxicity in Newly Diagnosed Chronic Phase CML:
In a prospective randomized clinical trial in the first-line
treatment of newly diagnosed patients with CP-CML, single agent
ICLUSIG 45 mg once daily increased the risk of serious adverse
reactions 2-fold compared to single agent imatinib 400 mg once
daily. The median exposure to treatment was less than 6 months. The
trial was halted for safety. Arterial and venous thrombosis and
occlusions occurred at least twice as frequently in the ICLUSIG arm
compared to the imatinib arm. Compared to imatinib-treated
patients, ICLUSIG-treated patients exhibited a greater incidence of
myelosuppression, pancreatitis, hepatotoxicity, cardiac failure,
hypertension, and skin and subcutaneous tissue disorders. ICLUSIG
is not indicated and is not recommended for the treatment of
patients with newly diagnosed CP-CML.
Neuropathy: Peripheral and cranial neuropathy occurred in
patients in PhALLCON, OPTIC and PACE. Some of these events in
PhALLCON and PACE were Grade 3 or 4. Monitor patients for symptoms
of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia,
discomfort, a burning sensation, neuropathic pain or weakness.
Interrupt, then resume at the same or reduced dose or discontinue
ICLUSIG based on recurrence/severity.
Ocular Toxicity: Serious or severe ocular toxicity
leading to blindness or blurred vision have occurred in
ICLUSIG-treated patients. The most frequent ocular toxicities
occurring in PhALLCON, OPTIC and PACE were dry eye, blurred vision,
and eye pain. Retinal toxicities included age-related macular
degeneration, macular edema, retinal vein occlusion, retinal
hemorrhage, and vitreous floaters. Conduct comprehensive eye exams
at baseline and periodically during treatment.
Hemorrhage: Fatal and serious hemorrhage events have
occurred in patients who received ICLUSIG. Fatal hemorrhages
occurred in PACE and serious hemorrhages occurred in PhALLCON,
OPTIC and PACE. In PACE, the incidence of serious bleeding events
was higher in patients with AP-CML, BP-CML, and Ph+ ALL.
Intracranial hemorrhage, gastrointestinal hemorrhage and subdural
hematoma were the most frequently reported serious hemorrhages.
Events often occurred in patients with Grade 4 thrombocytopenia.
Monitor for hemorrhage and manage patients as clinically indicated.
Interrupt, then resume at the same or reduced dose or discontinue
ICLUSIG based on recurrence/severity.
Fluid Retention: Fatal and serious fluid retention events
have occurred in patients who received ICLUSIG. In PACE, one
instance of brain edema was fatal and serious events included
pleural effusion, pericardial effusion, and angioedema. In PhALLCON
serious fluid retention included pericardial effusion. The most
frequent occurrences of fluid retention in patients who received
ICLUSIG were peripheral edema and pleural effusion. Monitor for
fluid retention and manage patients as clinically indicated.
Interrupt, then resume at the same or reduced dose or discontinue
ICLUSIG based on recurrence/severity.
Cardiac Arrhythmias: Cardiac arrhythmias, including
ventricular, atrial arrhythmias, tachycardia, syncope, atrial
fibrillation and supraventricular tachycardia occurred in patients
in PhALLCON, OPTIC, and PACE. For some patients, events were
serious or severe (Grade 3 or 4) and led to hospitalization.
Monitor for signs and symptoms suggestive of slow heart rate
(fainting, dizziness) or rapid heart rate (chest pain, palpitations
or dizziness) and manage patients as clinically indicated.
Interrupt, then resume at the same or reduced dose or discontinue
ICLUSIG based on recurrence/severity.
Myelosuppression: Grade 3 or 4 events of neutropenia,
thrombocytopenia, and anemia occurred in patients in PhALLCON,
OPTIC and PACE. In PACE, the incidence of myelosuppression was
greater in patients with AP-CML, BP-CML, and Ph+ ALL treated with
monotherapy than in patients with CP-CML. Obtain complete blood
counts every 2 weeks for the first 3 months and then monthly or as
clinically indicated. If ANC less than 1 x 109/L or platelets less
than 50 x 109/L, interrupt ICLUSIG until ANC at least 1.5 x 109/L
and platelets at least 75 x 109/L, then resume at same or reduced
dose.
Tumor Lysis Syndrome (TLS): Serious TLS was reported in
ICLUSIG-treated patients in PhALLCON, OPTIC and PACE. Ensure
adequate hydration and treat high uric acid levels prior to
initiating ICLUSIG.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS):
RPLS (also known as Posterior Reversible Encephalopathy Syndrome)
has been reported in patients who received ICLUSIG. Patients may
present with neurological signs and symptoms, visual disturbances,
and hypertension. Diagnosis is made with supportive findings on
magnetic resonance imaging (MRI) of the brain. Interrupt ICLUSIG
until resolution. The safety of resumption of ICLUSIG in patients
upon resolution of RPLS is unknown.
Impaired Wound Healing and Gastrointestinal Perforation:
Impaired wound healing occurred in patients receiving ICLUSIG.
Withhold ICLUSIG for at least 1 week prior to elective surgery. Do
not administer for at least 2 weeks following major surgery and
until adequate wound healing. The safety of resumption of ICLUSIG
after resolution of wound healing complications has not been
established. Gastrointestinal perforation or fistula occurred in
patients receiving ICLUSIG. Permanently discontinue in patients
with gastrointestinal perforation.
Embryo-Fetal Toxicity: Based on its mechanism of action
and findings from animal studies, ICLUSIG can cause fetal harm when
administered to a pregnant woman. Advise pregnant women of the
potential risk to the fetus. Advise females of reproductive
potential to use effective contraception during treatment with
ICLUSIG and for 3 weeks after the last dose.
ADVERSE REACTIONS The most common adverse reactions
(occurring in >20% of patients) are:
- ICLUSIG as a single agent: rash and related conditions,
arthralgia, abdominal pain, headache, constipation, dry skin,
hypertension, fatigue, fluid retention and edema, pyrexia, nausea,
pancreatitis/lipase elevation, hemorrhage, anemia, hepatic
dysfunction and AOEs. The most common Grade 3 or 4 laboratory
abnormalities (>20%) are platelet count decreased, neutrophil
cell count decreased, and white blood cell decreased.
- ICLUSIG in combination with chemotherapy: hepatic dysfunction,
arthralgia, rash and related conditions, headache, pyrexia,
abdominal pain, constipation, fatigue, nausea, oral mucositis,
hypertension, pancreatitis/lipase elevation, neuropathy peripheral,
hemorrhage, febrile neutropenia, fluid retention and edema,
vomiting, paresthesia and cardiac arrhythmias. The most common
Grade 3 or 4 laboratory abnormalities (>20%) are decreased white
blood cell count, decreased neutrophil cell count, decreased
platelet count, decreased lymphocyte cell count, decreased
hemoglobin, increased lipase and increased alanine
aminotransferase.
To report SUSPECTED ADVERSE REACTIONS, contact Takeda
Pharmaceuticals at 1-844-817-6468 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
DRUG INTERACTIONS Strong CYP3A
Inhibitors: Avoid coadministration or reduce ICLUSIG
dose if coadministration cannot be avoided. Strong CYP3A Inducers: Avoid
coadministration.
USE IN SPECIFIC POPULATIONS Lactation: Advise
women not to breastfeed during treatment with ICLUSIG and for 1
week following last dose.
Females and Males of Reproductive Potential: Verify
pregnancy status of females of reproductive potential prior to
initiating ICLUSIG.
Ponatinib may impair fertility in females, and it is not known
if these effects are reversible.
Pre-existing Hepatic Impairment: For patients with
CP-CML, AP-CML, BP-CML, and Ph+ ALL receiving monotherapy, reduce
the starting dose of ICLUSIG to 30mg orally once daily for patients
with pre-existing hepatic impairment as these patients are more
likely to experience adverse reactions compared to patients with
normal hepatic function. For patients with newly diagnosed Ph+ ALL,
no dosage adjustment is recommended.
Prescribing Information
Takeda’s Commitment to Oncology Our core R&D mission
is to deliver novel medicines to patients with cancer worldwide
through our commitment to science, breakthrough innovation and
passion for improving the lives of patients. Whether it’s with our
hematology therapies, our robust pipeline, or solid tumor
medicines, we aim to stay both innovative and competitive to bring
patients the treatments they need. For more information, visit
www.takedaoncology.com.
About Takeda Takeda is focused on creating better health
for people and a brighter future for the world. We aim to discover
and deliver life-transforming treatments in our core therapeutic
and business areas, including gastrointestinal and inflammation,
rare diseases, plasma-derived therapies, oncology, neuroscience and
vaccines. Together with our partners, we aim to improve the patient
experience and advance a new frontier of treatment options through
our dynamic and diverse pipeline. As a leading values-based,
R&D-driven biopharmaceutical company headquartered in Japan, we
are guided by our commitment to patients, our people and the
planet. Our employees in approximately 80 countries and regions are
driven by our purpose and are grounded in the values that have
defined us for more than two centuries. For more information, visit
www.takeda.com.
Important Notice For the purposes of this notice, “press
release” means this document, any oral presentation, any question
and answer session and any written or oral material discussed or
distributed by Takeda Pharmaceutical Company Limited (“Takeda”)
regarding this release. This press release (including any oral
briefing and any question-and-answer in connection with it) is not
intended to, and does not constitute, represent or form part of any
offer, invitation or solicitation of any offer to purchase,
otherwise acquire, subscribe for, exchange, sell or otherwise
dispose of, any securities or the solicitation of any vote or
approval in any jurisdiction. No shares or other securities are
being offered to the public by means of this press release. No
offering of securities shall be made in the United States except
pursuant to registration under the U.S. Securities Act of 1933, as
amended, or an exemption therefrom. This press release is being
given (together with any further information which may be provided
to the recipient) on the condition that it is for use by the
recipient for information purposes only (and not for the evaluation
of any investment, acquisition, disposal or any other transaction).
Any failure to comply with these restrictions may constitute a
violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns
investments are separate entities. In this press release, “Takeda”
is sometimes used for convenience where references are made to
Takeda and its subsidiaries in general. Likewise, the words “we”,
“us” and “our” are also used to refer to subsidiaries in general or
to those who work for them. These expressions are also used where
no useful purpose is served by identifying the particular company
or companies.
Forward-Looking Statements This press release and any
materials distributed in connection with this press release may
contain forward-looking statements, beliefs or opinions regarding
Takeda’s future business, future position and results of
operations, including estimates, forecasts, targets and plans for
Takeda. Without limitation, forward-looking statements often
include words such as “targets”, “plans”, “believes”, “hopes”,
“continues”, “expects”, “aims”, “intends”, “ensures”, “will”,
“may”, “should”, “would”, “could”, “anticipates”, “estimates”,
“projects” or similar expressions or the negative thereof. These
forward-looking statements are based on assumptions about many
important factors, including the following, which could cause
actual results to differ materially from those expressed or implied
by the forward-looking statements: the economic circumstances
surrounding Takeda’s global business, including general economic
conditions in Japan and the United States; competitive pressures
and developments; changes to applicable laws and regulations,
including global health care reforms; challenges inherent in new
product development, including uncertainty of clinical success and
decisions of regulatory authorities and the timing thereof;
uncertainty of commercial success for new and existing products;
manufacturing difficulties or delays; fluctuations in interest and
currency exchange rates; claims or concerns regarding the safety or
efficacy of marketed products or product candidates; the impact of
health crises, like the novel coronavirus pandemic, on Takeda and
its customers and suppliers, including foreign governments in
countries in which Takeda operates, or on other facets of its
business; the timing and impact of post-merger integration efforts
with acquired companies; the ability to divest assets that are not
core to Takeda’s operations and the timing of any such
divestment(s); and other factors identified in Takeda’s most recent
Annual Report on Form 20-F and Takeda’s other reports filed with
the U.S. Securities and Exchange Commission, available on Takeda’s
website at:
https://www.takeda.com/investors/sec-filings-and-security-reports/
or at www.sec.gov. Takeda does not undertake to update any of the
forward-looking statements contained in this press release or any
other forward-looking statements it may make, except as required by
law or stock exchange rule. Past performance is not an indicator of
future results and the results or statements of Takeda in this
press release may not be indicative of, and are not an estimate,
forecast, guarantee or projection of Takeda’s future results.
Medical Information This press release contains
information about products that may not be available in all
countries, or may be available under different trademarks, for
different indications, in different dosages, or in different
strengths. Nothing contained herein should be considered a
solicitation, promotion or advertisement for any prescription drugs
including the ones under development.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240319911372/en/
Media: Japanese Media Jun Saito
jun.saito@takeda.com +81 (0) 3-3278-2325 U.S. and International
Media Emy Gruppo emy.gruppo@takeda.com +1 667-444-2252
Takeda Pharmaceutical (NYSE:TAK)
Graphique Historique de l'Action
De Avr 2024 à Mai 2024
Takeda Pharmaceutical (NYSE:TAK)
Graphique Historique de l'Action
De Mai 2023 à Mai 2024