~ ARIAD to Receive More Than 50 Percent of
Iclusig Sales in These Regions
~ Agreements Include Buy-Back Provisions in
Case of a Change in Control of ARIAD
ARIAD Pharmaceuticals, Inc. (ARIAD; NASDAQ:ARIA) today announced
that it has completed two distribution agreements for Iclusig®
(ponatinib) outside of the United States. In Latin America, ARIAD
and Pint Pharma International S.A., a company focused on innovative
treatments for patients in Latin America with cancer, rare
diseases, and genetic disorders, have entered into an agreement for
Pint Pharma to commercialize Iclusig in Argentina, Brazil, Chile,
Colombia and Mexico. ARIAD has also entered into a separate
agreement with Biologix FZCo., a leading distributor of specialty
pharmaceuticals in the Middle East region, for Biologix to
commercialize Iclusig in the Middle East and North Africa (MENA),
including in Saudi Arabia, the Gulf Coast Countries, Lebanon, and
selected other countries in the region.
“Our new distribution agreements for Latin America and the
Middle East and North Africa markets demonstrate our commitment to
bringing Iclusig to patients around the world who are in need of
this important medicine for refractory CML and Ph+ ALL, while
continuing to focus our commercial resources on the U.S. market,”
stated Hugh Cole, chief business officer of ARIAD. “We believe that
our new partners in these geographies have the local expertise and
commitment to successfully commercialize Iclusig in their markets.
In addition to providing a significant share of revenues from these
regions, the agreements allow future strategic optionality for
ARIAD by including provisions for the buy-back of these Iclusig
rights by an acquirer of ARIAD in case of a change in control of
ARIAD.”
Agreement with Pint Pharma
Pint Pharma has received exclusive rights to commercialize
Iclusig following regulatory approval in Argentina, Brazil, Chile,
Colombia and Mexico (the “Territory”), with the potential of adding
other Latin American countries in the future. ARIAD and Pint have
agreed to collaborate to submit marketing authorization approvals
in the countries in the Territory. In addition, Pint has agreed to
sell Iclusig as an investigational product on a named patient basis
in certain countries in the territory where permitted prior to
regulatory approval.
In exchange for these rights, ARIAD will receive upfront and
potential regulatory milestone payments totaling $15 million. ARIAD
will also receive more than 50 percent of net product sales in the
Territory through a product supply transfer price.
“Over the past few years, we have focused on bringing important
oncology and rare disease treatments to Latin American countries,”
said David Muñoz, chief executive officer of Pint Pharma. “Together
with ARIAD, we plan to work to secure regulatory and reimbursement
approvals for Iclusig to be available to refractory
Philadelphia-positive leukemia patients in need of new treatment
options in the Territory.”
The terms of the distribution agreement include an option for an
acquirer of ARIAD to buy-back the rights to Iclusig in the
Territory following three years from the effective date of the
distribution agreement by making specified payments.
Agreement with Biologix FZCo.
Biologix has received exclusive rights to commercialize Iclusig
in Bahrain, the Kingdom of Saudi Arabia, Kuwait, Oman, Qatar, the
United Arab Emirates, Lebanon, and several other countries in the
region. In the initial phase of the agreement, Biologix has agreed
to sell Iclusig as an investigational product on a named patient
basis in certain countries in the territory where permitted prior
to regulatory approval, and thereafter to commercialize Iclusig in
those countries in which regulatory approval is achieved.
“We have an established oncology and hematology portfolio with
extensive experience in the Middle East, Gulf Coast and North
Africa,” said Selim Ghorayeb, chief executive officer of Biologix.
“Looking ahead to our partnership with ARIAD, we are dedicated to
bringing that experience to help appropriate patients access
Iclusig for resistant forms of CML and Ph+ ALL.”
Under the terms of the distribution agreement, ARIAD will
receive more than 50 percent of net product sales in the territory
through a product supply transfer price. The agreement also
includes an option for an acquirer of ARIAD to buy-back the rights
to Iclusig in the territory following three years from the
effective date of the distribution agreement by making specified
payments.
About CML and Ph+ ALL
CML is characterized by an excessive and unregulated production
of white blood cells by the bone marrow due to a genetic
abnormality that produces the BCR-ABL protein. After a chronic
phase of production of too many white blood cells, CML typically
evolves to the more aggressive phases referred to as accelerated
phase and blast crisis. Ph+ ALL is a subtype of acute lymphoblastic
leukemia that carries the Ph+ chromosome that produces BCR-ABL. It
has a more aggressive course than CML and is often treated with a
combination of chemotherapy and tyrosine kinase inhibitors. The
BCR-ABL protein is expressed in both of these diseases.
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 and Canada.
In the U.S., Iclusig is a kinase inhibitor indicated for
the:
• Treatment of adult patients with T315I-positive chronic
myeloid leukemia (chronic phase, accelerated phase, or blast phase)
or T315I-positive Philadelphia chromosome positive acute
lymphoblastic leukemia (Ph+ ALL).
• Treatment of adult patients with chronic phase, accelerated
phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom
no other tyrosine kinase inhibitor (TKI) therapy is indicated.
These indications are based upon response rate. There are no
trials verifying an improvement in disease-related symptoms or
increased survival with Iclusig.
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, INCLUDING THE BOXED
WARNING
WARNING: VASCULAR OCCLUSION, HEART FAILURE, and
HEPATOTOXICITY
See full 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 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. For additional information, visit
http://www.ariad.com or follow ARIAD on Twitter (@ARIADPharm).
About Pint Pharma
Pint Pharma is a private specialty pharma company which benefits
from specialized leaders with extensive experience in the
pharmaceutical sector and whom are based strategically throughout
Latin America and Europe. Pint Pharma has also a long track record
of developing strong relationships with global pharmaceutical and
healthcare companies. Pint Pharma has the ambition to become a
leading Latin American company delivering innovative treatments to
patients with cancers, rare diseases and genetic disorders.
About Biologix FZCo.
Biologix FZCo. is incorporated in the Dubai Airport Free Zone as
a regional promoter of specialty pharmaceutical products. Biologix
is focused on oncology-hematology, cardiology, central nervous
system, and rare diseases.
Biologix FZCo. mission is to accelerate the availability in the
MENA markets of innovative therapies that would not be normally
available until much later due to the focus of their manufacturers
on the larger markets of North America, Europe and Japan. Biologix
enables a win-win outcome for patients who would miss on an
effective treatment and for manufacturers who would not access the
MENA markets at such an early stage of their corporate
development.
ARIAD Forward-Looking Statements
This press release contains forward-looking statements, each of
which are qualified in their entirety by this cautionary statement.
Any statements contained herein which do not describe historical
facts, including, but not limited to, the ability of Pint Pharma
and Biologix FZCo. (collectively, the “Distributors”) to perform
the contracted services, such as obtaining regulatory approvals for
Iclusig in their respective territories; the Distributors’ ability
to distribute, promote, market and sell Iclusig in their respective
territories; the timing and scope of regulatory approvals obtained
in the covered territories; the timing and success of sales of
Iclusig in the territories; and the statements made by the officers
of ARIAD, Pint Pharma and Biologix FZCo., are forward-looking
statements that are based on management’s 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, competition from alternative therapies; regulatory developments
and safety issues, including difficulties or delays in obtaining
regulatory and pricing and reimbursement approvals to market our
products; our reliance on the performance of third-party
manufacturers and specialty pharmacies for the supply and
distribution of our products and product candidates; the occurrence
of adverse safety events with our products and product candidates;
the costs associated with our research, development, manufacturing,
commercialization and other activities; the adequacy of our capital
resources and the availability of additional funding; our
operations in foreign countries; risks related to key employees,
markets, economic conditions, health care reform, prices and
reimbursement rates; and other risk factors detailed in our public
filings with the U.S. Securities and Exchange Commission, including
our most recent Annual Report on Form 10-K and subsequent Quarterly
Reports on Form 10-Q. Except as otherwise noted, these
forward-looking statements speak only as of the date of this press
release and we undertake no obligation to update or revise any of
these statements to reflect events or circumstances occurring after
this press release. We caution investors not to place considerable
reliance on the forward-looking statements contained in this press
release.
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version on businesswire.com: http://www.businesswire.com/news/home/20160617005266/en/
ARIAD Pharmaceuticals, Inc.InvestorsManmeet S. Soni,
617-503-7298Manmeet.soni@ariad.comorMediaLiza Heapes,
617-621-2315Liza.heapes@ariad.com
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