- ARIAD to receive upfront payment of USD
77.5 million and subsequent milestone-based payments
- Otsuka to obtain rights in ten Asian
countries to Iclusig, a newest-generation treatment for patients
with refractory chronic myeloid leukemia and Ph+ acute
lymphoblastic leukemia
ARIAD Pharmaceuticals, Inc. (ARIAD; NASDAQ: ARIA) and Otsuka
Pharmaceutical Co., Ltd. (Otsuka) today announced that they have
entered into an agreement for Otsuka to commercialize ARIAD’s
Iclusig® (ponatinib) in Japan and nine other Asian countries and to
fund future clinical trials in those countries. ARIAD will lead the
completion of the Japanese New Drug Application (NDA) for Iclusig,
and Otsuka will file the NDA on behalf of both companies for
regulatory approval in resistant and intolerant chronic myeloid
leukemia (CML) and Philadelphia-chromosome positive acute
lymphoblastic leukemia (Ph+ALL) in 2015. Iclusig is an approved
BCR-ABL inhibitor in the United States, Europe and Australia.
The agreement provides for Otsuka to receive exclusive rights to
market Iclusig in Japan and nine other Asian countries (the
“Territory”) in return for an upfront payment of $77.5 million to
ARIAD, a milestone payment upon regulatory approval in Japan for
patients with resistant and intolerant Philadelphia-positive
leukemias, and additional milestone payments for approval in other
indications.
Following approvals in the Territory, Otsuka will conduct sales
activities and record sales. ARIAD will also receive a substantial
share of net product sales.
ARIAD will continue to fund the completion of its ongoing
pivotal trial of Iclusig that will form the basis of the filing for
regulatory approval in Japan, while Otsuka will fund additional
agreed-upon clinical studies in the Territory. For ARIAD-sponsored
global studies that include sites in Japan, Otsuka has the option
to contribute to the funding and gain access to the data for use in
the Territory.
“This agreement meets one of our key strategic objectives –
establishing a strong partnership with an experienced and committed
Japanese pharmaceutical company to commercialize and co-develop
Iclusig in Japan and Asia,” said Harvey J. Berger, M.D., chairman
and chief executive officer of ARIAD. “Otsuka is building a leading
hematology and oncology business in Japan and Asia and is an
outstanding partner to successfully commercializing Iclusig in
these markets.”
“Over the past several years, we have worked with the leading
hematology experts in Japan and have run the Phase 1/2 clinical
trial that will form the basis for our marketing authorization
application,” he added. “Together with Otsuka, we will be able to
make this cancer medicine available to refractory
Philadelphia-positive leukemia patients in need of new treatment
options.”
Otsuka Pharmaceutical President and Representative Director Taro
Iwamoto noted, “The future arrival of ARIAD’s ponatanib in Japan
and elsewhere in Asia will be an important evolution for patients
with CML and Philadelphia-positive ALL with BCR-ABL gene
expression, said to be particularly difficult to treat. Treatments
have been inadequate for patients with these life-threatening
conditions and we aim to contribute to improve the treatment
available to them. ARIAD’s high-level drug discovery technology
powered its discovery of ponatanib and Otsuka aims to maintain this
momentum by making it part of our expanded portfolio in blood
cancers from pre-treatment conditioning to treatments.”
A joint development and commercialization committee will oversee
clinical development and commercialization of Iclusig in the
Territory, including approval of any development or
commercialization plans. Otsuka will have exclusive commercial
rights to Iclusig and will promote it as its sole tyrosine kinase
inhibitor in the Territory. In addition to Japan, the other Asian
countries that are included in this agreement are China, South
Korea, Indonesia, Malaysia, the Philippines, Singapore, Taiwan,
Thailand and Vietnam.
About Iclusig® (ponatinib) tablets
Iclusig is a kinase inhibitor discovered by ARIAD. 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.
Important U.S. Safety Information for Iclusig®
(ponatinib)
WARNING: VASCULAR OCCLUSION, HEART FAILURE, and
HEPATOTOXICITY
See full U.S. prescribing information for complete boxed
warning
- Vascular Occlusion: Arterial and
venous thrombosis and occlusions have occurred in at least 27% of
Iclusig-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. Monitor for evidence of
thromboembolism and vascular occlusion. Interrupt or stop Iclusig
immediately for vascular occlusion. A benefit risk consideration
should guide a decision to restart Iclusig therapy.
- Heart Failure, including fatalities,
occurred in 8% 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.
Please see the full U.S. Prescribing Information
for Iclusig, including the Boxed Warning, for additional
important safety information.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts and Lausanne, Switzerland, is an integrated global
oncology company focused on transforming the lives of cancer
patients with breakthrough medicines. ARIAD is working on new
medicines to advance the treatment of various forms of chronic and
acute leukemia, lung cancer and other difficult-to-treat cancers.
ARIAD utilizes computational and structural approaches to design
small-molecule drugs that overcome resistance to existing cancer
medicines. For additional information, visit
http://www.ariad.com or follow ARIAD on Twitter
(@ARIADPharm).
About Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical is a global healthcare company with the
corporate philosophy: 'Otsuka-people creating new products for
better health worldwide.' Otsuka researches, develops, manufactures
and markets innovative and original products, with a focus on
pharmaceutical products for the treatment of diseases and
nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leading firm in the challenging
area of mental health and also has research programs in several
under-addressed diseases including several cancer categories and
tuberculosis, a significant global public health issue. These
commitments illustrate more powerfully than words how Otsuka is a
“big venture” company at heart, applying a youthful spirit of
creativity in everything it does.
Otsuka Pharmaceutical Co., Ltd., which employs approximately
28,700 people worldwide, is a wholly owned subsidiary of Otsuka
Holdings Co., Ltd., the holding company for the Otsuka Group that
is headquartered in Tokyo, Japan. The Otsuka Group has business
operations in 27 countries and regions around the world, with
consolidated sales of approximately USD 14.1 billion for fiscal
year 2013 (4/1/2013-3/31/2014.) Otsuka Pharmaceutical welcomes you
to visit its global website at https://www.otsuka.co.jp/en.
ARIAD Forward-Looking Statements
This press release contains “forward-looking statements” which
are based on management's good-faith expectations and are subject
to certain factors, risks and uncertainties that may cause actual
results, outcome of events, timing and performance to differ
materially from those expressed or implied by such statements.
These factors, risks and uncertainties include, but are not limited
to the Company’s ability to manufacture and supply Iclusig to
Otsuka; the ability of Otsuka to perform the contracted services,
such as obtaining marketing authorizations, other regulatory
approvals, and pricing and reimbursement approvals for Iclusig in
the countries covered by the collaboration agreement (“Territory”);
Otsuka’s ability to distribute, promote, market and sell Iclusig in
the Territory; Otsuka’s ability to fund the clinical development of
Iclusig in the Territory; the timing and scope of the marketing
authorizations obtained in the Territory, as well as the level of
pricing obtained in Territory; third-party reimbursement; and the
timing and success of sales of Iclusig in the Territory. These
factors, risks and uncertainties also include, but are not limited
to the costs associated with ARIAD’s development and manufacturing,
commercial and other activities; the adequacy of capital resources
and the availability of additional funding; and other factors
detailed in the Company's public filings with the U.S. Securities
and Exchange Commission. The information contained in this press
release is believed to be current as of the date of original issue.
After the date of this document, the Company does not intend to
update any of the forward-looking statements to conform to actual
results or to changes in the Company's expectations, except as
required by law.
Contacts at ARIADFor InvestorsKendra
Adams, 617-503-7028Kendra.adams@ariad.comorFor
MediaLiza Heapes,
617-621-2315Liza.heapes@ariad.comorContacts at
OtsukaFor InvestorsYoko Ishii, +81 3 6361
7411Ishiiyo@Otsuka.jporFor MediaJeffrey
Gilbert, +81 3 6361 7379, +81 80 8728
6039Gilbert.jeffrey@Otsuka.jp
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