– Significantly Enhances Takeda’s Global
Oncology Portfolio –
– Accretive to FY2018 Underlying Core Earnings
–
– Reinforces Takeda’s Commitment to Developing
Medicines for Patients Living with Cancer –
Strategic Highlights
- Highly strategic deal which transforms
global oncology portfolio and pipeline by expanding into solid
tumors and reinforcing existing strength in hematology
- Accretive to Takeda’s Underlying Core
Earnings by FY2018 and generates immediate and long-term revenue
growth
- Attractive value drivers include two
very innovative precision medicines, Iclusig® (ponatinib) and
brigatinib, an exciting early stage pipeline and cost synergies
- Iclusig is a globally commercialized
product with continued strong sales growth potential
- Brigatinib approval in the U.S. is
expected in the first half of 2017, with peak sales potential over
$1 billion and the potential to be the best-in-class ALK
inhibitor
- Takeda will leverage ARIAD’s research
and development capabilities and platform
- Takeda retains financial flexibility
with no impact on dividend policy
Takeda Pharmaceutical Company Limited (TSE:4502) (“Takeda”) and
ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) (“ARIAD”) today announced
that they have entered into a definitive agreement under which
Takeda will acquire all of the outstanding shares in ARIAD for
$24.00 per share in cash, or an enterprise value of approximately
$5.2 billion. The transaction has been approved unanimously by the
boards of directors of both companies, and is expected to close by
the end of February 2017, subject to required regulatory approvals
and other customary closing conditions. Sarissa Capital, the holder
of 6.6% of ARIAD’s common shares, as well as each of the members of
ARIAD’s Board of Directors have agreed to tender their shares to
Takeda pursuant to the offer.
“The acquisition of ARIAD is a unique opportunity that will
enable us to positively impact the lives of more patients
worldwide, advance our strategic priorities and generate attractive
returns for our shareholders,” said Christophe Weber, president and
chief executive officer of Takeda. “This is a very exciting time
for Takeda as we will broaden our hematology portfolio and
transform our global solid tumor franchise through the addition of
two innovative targeted therapies. Opportunities to acquire such
high-quality, complementary targeted therapies do not come often,
and we are very excited about the potential for this transaction to
benefit patients, our shareholders and other stakeholders.”
Paris Panayiotopoulos, president and chief executive officer of
ARIAD, said, “We are very pleased to combine with Takeda, which
will allow us to not only accelerate our mission to discover,
develop and deliver precision therapies to patients with rare
cancers, but also deliver immediate and meaningful value to our
shareholders through a substantial cash premium. This exciting
transaction is a testament to the hard work and dedication of
ARIAD’s talented team of employees. We have tremendous respect for
Takeda, and I believe our shared commitment to innovation and
research-driven cultures will provide for a smooth transition.”
“This transaction is a great outcome for shareholders of ARIAD
and Takeda. Both ARIAD and Takeda are passionate about helping
cancer patients, and I believe the talent and resources of Takeda
coupled with ARIAD’s pipeline and people will accelerate the
development of cancer treatments. I would like to extend my
deepest gratitude to the management team and everyone at ARIAD for
their unrelenting dedication,” said Alexander J. Denner, Ph.D.,
Chairman of the Board of ARIAD.
Highly strategic deal which transforms global oncology
portfolio and pipeline by expanding into solid tumors and
reinforcing existing strength in hematology
The acquisition of ARIAD brings two innovative targeted
therapies that will expand and enhance Takeda’s existing oncology
portfolio. Brigatinib, an investigational drug product, has the
potential to add a differentiated, global therapy in a
genetically-defined subpopulation of non-small cell lung cancer
(NSCLC). The addition of Iclusig will broaden Takeda’s strong
hematology franchise to include chronic myeloid leukemia (CML) and
a subset of acute lymphoblastic leukemia (ALL). Together, these two
innovative targeted therapies will position Takeda for sustainable
long-term growth in oncology.
Takeda’s track record of successful oncology product launches
[ADCETRIS® (Brentuximab Vedotin), NINLAROTM (ixazomib) and VELCADE®
(bortezomib)] means it has the experience and expertise required to
deliver the successful launch of brigatinib and to ensure that it
achieves global reach and share of voice thereafter.
Accretive to Takeda’s Underlying Core Earnings by FY2018 and
generates immediate and long-term revenue growth
The transaction is a compelling opportunity for Takeda
shareholders. It will provide immediate revenue, bring considerable
long-term revenue potential and deliver synergy savings.
ARIAD provided calendar year 2016 revenue guidance for Iclusig
of $170-180 million, and Takeda expects significant long-term
revenue potential from the two lead assets.
Takeda projects the acquisition of ARIAD to be accretive to
Underlying Core Earnings by FY2018 and broadly neutral in FY2017.
Strong revenue growth and synergy savings will offset increased
sales and marketing costs for the brigatinib launch.
Attractive value drivers include two very innovative
medicines, Iclusig and brigatinib, an exciting early stage pipeline
and cost synergies
Iclusig, a commercialized therapy with continued strong sales
growth potential, delivers immediate value. Brigatinib, an
investigational drug product with peak annual sales potential of
over $1 billion, will generate significant long-term value for
Takeda. U.S. approval is expected in the first half of 2017 with
global filing thereafter. Beyond Iclusig and brigatinib, ARIAD’s
commitment and expertise in targeted kinase inhibition linked to
strong translational science generated further pipeline
opportunities which provide additional long-term upside
potential.
Takeda will leverage ARIAD’s R&D capabilities and platform,
and largely absorb its R&D costs within Takeda's existing
R&D budget. G&A cost synergies will be fully captured by
FY2018.
Takeda retains financial flexibility with no impact on
dividend policy
The transaction will be funded by up to $4.0 billion of new debt
and the remainder from existing cash. FY2017 Net Debt/EBITDA is
estimated at approximately 2.6x, which is expected to remain
investment grade. The transaction has no impact on Takeda’s
dividend policy.
Transaction terms
The acquisition is structured as an all cash tender offer by a
subsidiary of Takeda for all of the outstanding shares of ARIAD
common stock, followed by a merger in which remaining shares of
ARIAD would be converted into the right to receive the same $24.00
cash per share price paid in the tender offer and ARIAD will become
an indirect wholly owned subsidiary of Takeda.
The transaction is subject to the tender of a majority of the
outstanding shares of ARIAD common stock as well as other customary
closing conditions, including expiration of the applicable waiting
period under the Hart-Scott-Rodino Antitrust Improvements Act of
1976 and the antitrust laws of applicable foreign jurisdictions.
The transaction is expected to close by the end of February
2017.
Takeda Pharmaceuticals U.S.A, a wholly owned subsidiary of
Takeda, has established Kiku Merger Co., Inc. to effect the
transaction.
(1) Tender offeror Kiku Merger Co., Inc. (2) Target company
ARIAD Pharmaceuticals, Inc. (3) Class of shares to be acquired
Common stock (4) Tender offer price $24.00 per share (5)
Acquisition amount
(Aggregate tender offer price)
Approximately $5.4 billion (estimate)
* The amount is an estimated amount
calculated by multiplying the number of the target company's shares
(fully diluted basis) by the tender offer price per share. It does
not include advisory fees.
(6) Payment Cash
* Funded by up to $4.0 billion of new debt
and the remainder from existing cash.
(7) Period of tender offer From January, 2017 to February, 2017
** The initial period of the tender offer
will commence within 10 business days following execution of the
merger agreement with ARIAD [January 8, 2017 (U.S.)], and will
close 20 business days after commencement. If the situation arises
whereby the conditions of the tender offer are not satisfied, the
period of the tender offer will be extended, but the extension
period will not exceed May 2017 (or August 2017 if antitrust
clearance not received).
(8) Minimum number of shares to be purchased Consummation of the
tender offer will occur once the majority of shares outstanding of
the company have been tendered and other customary closing
conditions have been satisfied. (9) Financial advisor to Takeda
Evercore Partners (10) Legal counsel to Takeda Cleary Gottlieb
Steen & Hamilton LLP (11) Financial advisor to ARIAD J.P.
Morgan Securities LLC, Goldman, Sachs & Co., Lazard (12) Legal
counsel to ARIAD Paul, Weiss, Rifkind, Wharton & Garrison LLP
Overview of ARIAD
(1) Company name ARIAD Pharmaceuticals, Inc. (2)
Headquarters 125 Binney Street, Cambridge, Massachusetts 02142, USA
(3) Representative Paris Panayiotopoulos, President and Chief
Executive Officer (4) Business description ARIAD Pharmaceuticals,
Inc., headquartered in Cambridge, Massachusetts is focused on
discovering, developing and commercializing precision therapies for
patients with rare cancers. ARIAD is working on new medicines to
advance the treatment of rare forms of chronic and acute leukemia,
lung cancer and other rare cancers. ARIAD utilizes computational
and structural approaches to design small-molecule drugs that
overcome resistance to existing cancer medicines. (5) Capital
US$1,339 million (Additional paid-in capital as of December 31,
2015) (6) Date of establishment April, 1991 (7) Major shareholders
and percentage of
shares held*
Wellington Management Group LLP 8.8% FMR LLC 7.8% Vanguard Group
Inc. 6.8% Others (8) Relationships between Takeda Capital
relationship Not applicable Personnel relationship Not applicable
Transactional relationship Not applicable (9) Operating result and
financial conditions for the last three years (consolidated)
Accounting period Fiscal year ended December 31, 2013 Fiscal year
ended December 31, 2014 Fiscal year ended December 31, 2015 Net
assets
(US$ in thousands)
185,517 80,801 (103,141) Total assets
(US$ in thousands)
370,894 603,116 546,692 Net assets per share
(US$)
1.01 0.43 (0.55) Revenue
(US$ in thousands)
45,561 105,412 118,804 Operating profit
(US$ in thousands)
(273,566) (160,195) (217,276) Net loss
(US$ in thousands)
(274,158) (162,602) (231,156) Net loss per share
(US$)
(1.49) (0.87) (1.23)
* As reported in the 13F filings. Percentage of shares is
calculated by dividing the number of shareholdings (as of the end
of September 2016) by the number of total shares outstanding of the
target company.
Change in ownership before and after
acquisition
(1) Number of shares already acquired 0 shares
Percentage of voting rights: 0%
(2) Number of shares to be acquired 194,389,661 shares*
Percentage of voting rights: 100%
(planned)
* Total shares outstanding
Schedule
(1) Board meeting resolution January 6, 2017 (2) Signing date
January 8, 2017 (3) Commencement date and settlement date of the
tender offer From January, 2017 to February, 2017
**The initial period of the tender offer
will commence within 10 business days following execution of the
merger agreement with ARIAD [January 8, 2017 (U.S.)], and will
close 20 business days after commencement. If the conditions of the
tender offer are not satisfied, the period of the tender offer will
be extended, but the extension period will not exceed May 2017 (or
August 2017 if antitrust clearance not received).
(4) Completion of acquisition By the end of February, 2017
(planned)*
* Fulfillment of the terms and conditions of the U.S. Antitrust
Law and the satisfaction of certain other customary conditions are
required to complete the acquisition.
Outlook
FY2016
At this stage we expect minimal impact on Underlying Revenue and
Underlying Core Earnings. We do expect to incur transition and
integration expenses, however, these expenses are not material to
the current year result. We will incorporate the financial impact
in our FY2016 consolidated earnings forecast and announce at the
third quarter earnings conference in February 2017.
FY2017 and beyond
It is expected that the acquisition of ARIAD will be accretive
to Takeda’s Underlying Core Earnings by FY2018 and broadly neutral
in FY2017. Strong revenue growth and synergy savings will offset
increased sales and marketing costs for the brigatinib launch.
Takeda’s financial guidance, including EPS, for FY2017 will be
announced when Takeda reports earnings for FY2016 in May 2017.
Conference Call Webcast
Information
Takeda will host a media/investors conference call at 7:30 p.m.
EST January 9, 2017 (9:30 a.m. JST January 10, 2017) to discuss the
transaction.
You can listen to the conference call at the following link:
http://www.Takeda.com/investor-information/results/
A replay of the conference call will be available within 24
hours.
In light of this announcement, ARIAD will not be presenting
today at the 35th Annual J.P. Morgan Healthcare Conference.
About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, research and
development-driven pharmaceutical company committed to bringing
better health and a brighter future to patients by translating
science into life-changing medicines. Takeda focuses its R&D
efforts on oncology, gastroenterology and central nervous system
therapeutic areas plus vaccines. Takeda conducts R&D both
internally and with partners to stay at the leading edge of
innovation. New innovative products, especially in oncology and
gastroenterology, as well as our presence in Emerging Markets, fuel
the growth of Takeda. More than 30,000 Takeda employees are
committed to improving quality of life for patients, working with
our partners in health care in more than 70 countries. Additional
information about Takeda is available through its corporate
website, www.Takeda.com.
About Iclusig® (ponatinib) tablets
Iclusig is a kinase inhibitor. The primary target for Iclusig is
BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic
myeloid leukemia (CML) and Philadelphia-chromosome positive
acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using
ARIAD's computational and structure-based drug-design platform
specifically to inhibit the activity of BCR-ABL. Iclusig targets
not only native BCR-ABL but also its isoforms that carry mutations
that confer resistance to treatment, including the T315I mutation,
which has been associated with resistance to other approved TKIs.
Iclusig is approved in the U.S.,
EU, Australia, Switzerland, Israel, Canada and Japan.
In the U.S., Iclusig is a kinase inhibitor indicated for
the:
- Treatment of adult patients with
chronic phase, accelerated phase, or blast phase chronic myeloid
leukemia (CML) or Philadelphia chromosome positive acute
lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase
inhibitor (TKI) therapy is indicated.
- Treatment of adult patients with
T315I-positive chronic myeloid leukemia (chronic phase, accelerated
phase, or blast phase) or T315I-positive Ph+ ALL.
Limitations of use:
Limitations of use: Iclusig is not indicated and is
not recommended for the treatment of patients with newly diagnosed
chronic phase CML.
IMPORTANT SAFETY INFORMATION
Based on the Phase 2 48 mo. follow-up analysis (N=449), except
where noted
IMPORTANT U.S. SAFETY INFORMATION, INCLUDING THE BOXED
WARNING
WARNING: ARTERIAL OCCLUSION, VENOUS THROMBOEMBOLISM, HEART
FAILURE, and HEPATOTOXICITY
See full prescribing information for
complete boxed warning.
- Arterial occlusion has occurred in
at least 35% of Iclusig® (ponatinib)-treated
patients including 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 less than 50 years old, experienced these events.
Interrupt or stop Iclusig immediately for arterial occlusion. A
benefit-risk consideration should guide a decision to restart
Iclusig.
- Venous Thromboembolism has occurred
in 6% of Iclusig-treated patients. Monitor for evidence of
thromboembolism. Consider dose modification or discontinuation of
Iclusig in patients who develop serious venous
thromboembolism.
- Heart Failure, including fatalities
occurred in 9% of Iclusig treated patients. Monitor cardiac
function. Interrupt or stop Iclusig for new or worsening heart
failure.
- Hepatotoxicity, liver failure and
death have occurred in Iclusig-treated patients. Monitor hepatic
function. Interrupt Iclusig if hepatotoxicity is
suspected.
Warnings and Precautions
Arterial Occlusions: Arterial occlusions, including
fatal myocardial infarction, stroke, stenosis of large arterial
vessels of the brain, severe peripheral vascular disease have
occurred in at least 35% of Iclusig-treated patients from the phase
1 and phase 2 trials. In the phase 2 trial, 33% (150/449) of
Iclusig-treated patients experienced a cardiac vascular (21%),
peripheral vascular (12%), or cerebrovascular (9%) arterial
occlusive event; some patients experienced more than 1 type of
event. Fatal and life-threatening events have occurred within 2
weeks of starting treatment, with doses as low as 15 mg per day.
Iclusig can also cause recurrent or multi-site vascular occlusion.
Patients have required revascularization procedures. The median
time to onset of the first cardiac vascular, cerebrovascular, and
peripheral vascular arterial occlusive events was 193, 526, and 478
days, respectively. Patients with and without cardiovascular risk
factors, some age 50 years or younger, experienced these events.
The most common risk factors observed with these events were
hypertension, hyperlipidemia, and history of cardiac disease.
Arterial occlusive events were more frequent with increasing age
and in patients with a history of ischemia, hypertension, diabetes,
or hyperlipidemia. In patients suspected of developing arterial
occlusive events, interrupt or stop Iclusig.
Venous Thromboembolism: Venous thromboembolic events
occurred in 6% (25/449) of Iclusig-treated patients with an
incidence rate of 5% (13/270 CP-CML), 4% (3/85 AP-CML), 10% (6/62
BP-CML) and 9% (3/32 Ph+ ALL). Events included: deep venous
thrombosis, pulmonary embolism, superficial thrombophlebitis, and
retinal vein thrombosis with vision loss. Consider dose
modification or discontinuation of Iclusig in patients who develop
serious venous thromboembolism.
Heart Failure: Fatal or serious heart failure or left
ventricular dysfunction occurred in 6% of Iclusig-treated patients
(29/449). Nine percent of patients (39/449) experienced any grade
of heart failure or left ventricular dysfunction. The most
frequently reported heart failure events were congestive cardiac
failure and decreased ejection fraction (14 patients each; 3%).
Monitor patients for signs or symptoms consistent with heart
failure and treat as clinically indicated, including interruption
of Iclusig. Consider discontinuation if serious heart failure
develops.
Hepatotoxicity: Iclusig can cause hepatotoxicity,
including liver failure and death. Fulminant hepatic failure
leading to death occurred in a patient within one week of starting
Iclusig. Two additional fatal cases of acute liver failure also
occurred. The fatal cases occurred in patients with BP-CML or Ph+
ALL. Severe hepatotoxicity occurred in all disease cohorts, with
11% (50/449) experiencing grade 3 or 4 hepatotoxicity. The most
common forms of hepatotoxicity were elevations of AST or ALT (54%
all grades, 8% grade 3 or 4, 5% not reversed at last follow-up),
bilirubin, and alkaline phosphatase. Hepatotoxic events were
observed in 29% of patients. The median time to onset of
hepatotoxicity event was 3 months. Monitor liver function
tests at baseline, then at least monthly or as clinically
indicated. Interrupt, reduce or discontinue Iclusig as clinically
indicated.
Hypertension: Treatment-emergent elevation of
systolic or diastolic blood pressure (BP) occurred in 68% (306/449)
of Iclusig-treated patients. Fifty-three patients (12%) experienced
treatment-emergent symptomatic hypertension as a serious adverse
reaction, including hypertensive crisis. Patients may require
urgent clinical intervention for hypertension associated with
confusion, headache, chest pain, or shortness of breath. In
patients with baseline systolic BP<140 mm Hg and baseline
diastolic BP<90 mm Hg, 80% (229/285) experienced
treatment-emergent hypertension; 44% (124/285) developed Stage 1
hypertension, 37% developed Stage 2 hypertension. In 132 patients
with Stage 1 hypertension at baseline, 67% (88/132) developed Stage
2 hypertension. Monitor and manage blood pressure elevations during
Iclusig use and treat hypertension to normalize blood pressure.
Interrupt, dose reduce, or stop Iclusig if hypertension is not
medically controlled. In the event of significant worsening, labile
or treatment-resistant hypertension, interrupt treatment and
consider evaluating for renal artery stenosis.
Pancreatitis: Pancreatitis occurred in 7% (31/449,
6% serious or grade 3/4) of Iclusig-treated patients. The incidence
of treatment-emergent lipase elevation was 42% (16% grade 3 or
greater). Pancreatitis resulted in discontinuation or treatment
interruption in 6% of patients (26/449). The median time to onset
of pancreatitis was 14 days. Twenty-three of the 31 cases of
pancreatitis resolved within 2 weeks with dose interruption or
reduction. Check 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. Dose interruption or reduction may
be required. In cases where lipase elevations are accompanied by
abdominal symptoms, interrupt treatment with Iclusig and evaluate
patients for pancreatitis. Do not consider restarting Iclusig until
patients have complete resolution of symptoms and lipase levels are
less than 1.5 x ULN.
Increased Toxicity in Newly Diagnosed Chronic Phase
CML: In a prospective randomized clinical trial in the
first-line treatment of newly diagnosed patients with chronic phase
(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 in October
2013. 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 have
occurred in Iclusig-treated patients. Overall, 20% (90/449) of
Iclusig-treated patients experienced a peripheral neuropathy event
of any grade (2%, grade 3/4). The most common peripheral
neuropathies reported were paresthesia (5%, 23/449), neuropathy
peripheral (4%, 19/449), hypoesthesia (3%, 15/449), dysgeusia (2%,
10/449), muscular weakness (2% 10/449) and hyperesthesia (1%,
5/449). Cranial neuropathy developed in 2% (10/449) of
Iclusig-treated patients (<1%, 3/449 - grade 3/4). Of the
patients who developed neuropathy, 26% (23/90) developed neuropathy
during the first month of treatment. Monitor patients for symptoms
of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia,
discomfort, a burning sensation, neuropathic pain or weakness.
Consider interrupting Iclusig and evaluate if neuropathy is
suspected.
Ocular Toxicity: Serious ocular toxicities leading
to blindness or blurred vision have occurred in Iclusig-treated
patients. Retinal toxicities including macular edema, retinal vein
occlusion, and retinal hemorrhage occurred in 2% of Iclusig-treated
patients. Conjunctival irritation, corneal erosion or abrasion, dry
eye, conjunctivitis, conjunctival hemorrhage, hyperaemia and edema
or eye pain occurred in 14% of patients. Visual blurring occurred
in 6% of patients. Other ocular toxicities include cataracts,
periorbital edema, blepharitis, glaucoma, eyelid edema, ocular
hyperaemia, iritis, iridocyclitis, and ulcerative keratitis.
Conduct comprehensive eye exams at baseline and periodically during
treatment.
Hemorrhage: Serious hemorrhage events including
fatalities, occurred in 6% (28/449) of patients treated with
Iclusig. Hemorrhage occurred in 28% (124/449) of patients. The
incidence of serious bleeding events was higher in patients with
AP-CML, BP-CML, and Ph+ ALL. Gastrointestinal hemorrhage and
subdural hematoma were the most commonly reported serious bleeding
events occurring in 1% (4/449) each. Most hemorrhagic events, but
not all, occurred in patients with grade 4 thrombocytopenia.
Interrupt Iclusig for serious or severe hemorrhage and
evaluate.
Fluid Retention: Fluid retention events judged as
serious occurred in 4% (18/449) of patients treated with Iclusig.
One instance of brain edema was fatal. For fluid retention events
occurring in >2% of the patients (treatment-emergent), serious
cases included: pleural effusion (7/449, 2%), pericardial effusion
(4/449, 1%), and edema peripheral (2/449, <1%).
In total, fluid retention occurred in 31% of the patients. The
most common fluid retention events were peripheral edema (17%),
pleural effusion (8%), pericardial effusion (4%) and peripheral
swelling (3%).
Monitor patients for fluid retention and manage patients as
clinically indicated. Interrupt, reduce, or discontinue Iclusig as
clinically indicated.
Cardiac
arrhythmias: Arrhythmias occurred in 19%
(86/449) of Iclusig-treated patients, of which 7% (33/449) were
grade 3 or greater. Arrhythmia of ventricular origin was reported
in 3% (3/86) of all arrhythmias, with one case being grade 3 or
greater. Symptomatic bradyarrhythmias that led to pacemaker
implantation occurred in 1% (3/449) of Iclusig-treated
patients.
Atrial fibrillation was the most common arrhythmia and occurred
in 7% (31/449) of patients, approximately half of which were grade
3 or 4. Other grade 3 or 4 arrhythmia events included syncope (9
patients; 2.0%), tachycardia and bradycardia (2 patients each
0.4%), and electrocardiogram QT prolonged, atrial flutter,
supraventricular tachycardia, ventricular tachycardia, atrial
tachycardia, atrioventricular block complete, cardio-respiratory
arrest, loss of consciousness, and sinus node dysfunction (1
patient each 0.2%). For 27 patients, the event led to
hospitalization.
In patients with signs and symptoms suggestive of slow heart
rate (fainting, dizziness) or rapid heart rate (chest pain,
palpitations or dizziness), interrupt Iclusig and evaluate.
Myelosuppression: Myelosuppression was reported as
an adverse reaction in 59% (266/449) of Iclusig-treated patients
and grade 3/4 myelosuppression occurred in 50% (226/449) of
patients. The incidence of these events was greater in patients
with AP-CML, BP-CML, and Ph+ ALL than in patients with CP-CML.
Severe myelosuppression (Grade 3 or 4) was observed early in
treatment, with a median onset time of 1 month (range <1-40
months). Obtain complete blood counts every 2 weeks for the first 3
months and then monthly or as clinically indicated, and adjust the
dose as recommended.
Tumor Lysis Syndrome: Two patients (<1%, one with
AP-CML and one with BP-CML) treated with Iclusig developed serious
tumor lysis syndrome. Hyperuricemia occurred in 7% (31/449) of
patients. Due to the potential for tumor lysis syndrome in patients
with advanced disease, ensure adequate hydration and treat high
uric acid levels prior to initiating therapy with Iclusig.
Reversible Posterior Leukoencephalopathy Syndrome
(RPLS): Postmarketing cases of reversible posterior
leukoencephalopathy syndrome (RPLS—also known as Posterior
Reversible Encephalopathy Syndrome (PRES)) have been reported in
Iclusig-treated patients. RPLS is a neurological disorder that can
present with signs and symptoms such as seizure, headache,
decreased alertness, altered mental functioning, vision loss, and
other visual and neurological disturbances. Hypertension is often
present and diagnosis is made with supportive findings on magnetic
resonance imaging (MRI) of the brain. If RPLS is diagnosed,
interrupt Iclusig treatment and resume treatment only once the
event is resolved and if the benefit of continued treatment
outweighs the risk of RPLS.
Compromised Wound Healing and Gastrointestinal
Perforation: Since Iclusig may compromise wound healing,
interrupt Iclusig for at least 1 week prior to major surgery.
Serious gastrointestinal perforation (fistula) occurred in one
patient 38 days post-cholecystectomy.
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. In animal reproduction
studies, oral administration of ponatinib to pregnant rats during
organogenesis caused adverse developmental effects at exposures
lower than human exposures at the recommended human dose. 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.
Most Common Adverse Reactions: Overall, the most
common non-hematologic adverse reactions (≥20%) were abdominal
pain, rash, constipation, headache, dry skin, fatigue,
hypertension, pyrexia, arthralgia, nausea, diarrhea, lipase
increased, vomiting, myalgia and pain in extremity. Hematologic
adverse reactions included thrombocytopenia, anemia, neutropenia,
lymphopenia, and leukopenia.
Please see the full U.S. Prescribing
Information for Iclusig, including the Boxed
Warning.
Iclusig is a registered trademark of ARIAD Pharmaceuticals,
Inc.
Additional Information
The tender offer described in this press release has not yet
commenced. This press release is provided for informational
purposes only and does not constitute an offer to purchase or the
solicitation of an offer to sell any securities. At the time the
tender offer is commenced, Takeda and its wholly owned subsidiary,
Kiku Merger Co., Inc., intend to file with the Securities and
Exchange Commission (the “SEC”) a Tender Offer Statement on
Schedule TO containing an offer to purchase, a form of letter of
transmittal and other documents relating to the tender offer, and
ARIAD intends to file with the SEC a Solicitation/Recommendation
Statement on Schedule 14D 9 with respect to the tender offer.
Takeda, Kiku Merger Co., Inc. and ARIAD intend to mail these
documents to the ARIAD stockholders. Investors and shareholders
should read those filings carefully when they become available as
they will contain important information about the tender offer.
Those documents may be obtained without charge at the SEC’s website
at www.sec.gov. The offer to purchase and related materials may
also be obtained (when available) for free by contacting the
information agent for the tender offer.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking information related
to Takeda, ARIAD and the proposed acquisition of ARIAD by Takeda
that involves substantial risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
by such statements. Forward-looking statements in this document
include, among other things, statements about the potential
benefits of the proposed acquisition, anticipated earnings
accretion and growth rates, Takeda’s and ARIAD’s plans, objectives,
expectations and intentions, the financial condition, results of
operations and business of Takeda and ARIAD, ARIAD’s products,
ARIAD’s pipeline assets, and the anticipated timing of closing of
the acquisition. Risks and uncertainties include, among other
things, risks related to the satisfaction of the conditions to
closing the acquisition (including the failure to obtain necessary
regulatory approvals) in the anticipated timeframe or at all,
including uncertainties as to how many of ARIAD’s stockholders will
tender their shares in the tender offer and the possibility that
the acquisition does not close; risks related to the ability to
realize the anticipated benefits of the acquisition, including the
possibility that the expected benefits from the proposed
acquisition will not be realized or will not be realized within the
expected time period; the risk that the businesses will not be
integrated successfully; disruption from the transaction making it
more difficult to maintain business and operational relationships;
negative effects of this announcement or the consummation of the
proposed acquisition on the market price of Takeda’s common stock
and on Takeda’s operating results; significant transaction costs;
unknown liabilities; the risk of litigation and/or regulatory
actions related to the proposed acquisition; other business
effects, including the effects of industry, market, economic,
political or regulatory conditions; future exchange and interest
rates; changes in tax and other laws, regulations, rates and
policies; future business combinations or disposals; the
uncertainties inherent in research and development, including the
ability to sustain and increase the rate of growth in revenues for
ARIAD’s products despite increasing competitive, reimbursement and
economic challenges; whether and when any drug applications may be
filed in any jurisdictions for any indications or any additional
indications for ARIAD’s products or for ARIAD’s pipeline assets;
whether and when the FDA or any other applicable regulatory
authorities may approve any such applications, which will depend on
its assessment of the benefit-risk profile suggested by the
totality of the efficacy and safety information submitted;
decisions by the FDA or other regulatory authorities regarding
labeling and other matters that could affect the availability or
commercial potential of ARIAD’s products and ARIAD’s pipeline
assets; and competitive developments.
Many of these factors are beyond Takeda’s control. Unless
otherwise required by applicable law, Takeda disclaims any
intention or obligation to update forward-looking statements
contained in this document as the result of new information or
future events or developments.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170109005531/en/
Media and Investor ContactsTakeda Investor
ContactNoriko Higuchi, +81 (0)
3-3278-2306noriko.higuchi@Takeda.comorTakeda Media outside
JapanShawn Goodman,
415-250-0766shawn.goodman@Takeda.comorJapanese MediaTsuyoshi
Tada, +81 (0) 3-3278-2417tsuyoshi.tada@Takeda.comorKal Goldberg,
Finsbury, 646-805-2005kal.goldberg@finsbury.comorChris
Ryall, Finsbury, 646-805-2078chris.ryall@finsbury.comorARIAD
Investor ContactManmeet Soni,
617-503-7298manmeet.soni@ariad.comorARIAD Media
ContactsSteve Frankel, Jed Repko, Leigh Parrish,Joele Frank,
Wilkinson Brimmer Katcher212-355-4449
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