Ariad Pharmaceuticals Inc fka ARIA

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ARIAD Pharmaceuticals, Inc. has added a news release to its Investor Relations website.
Title: ARIAD Announces Submission of Marketing Authorization Application for Ponatinib to the European Medicines Agency

Date(s): 30-Aug-2012 7:36 AM

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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 30, 2012--
ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced the submission
of a Marketing Authorization Application (MAA) for its investigational
BCR-ABL inhibitor, ponatinib, to the European Medicines Agency (EMA).
ARIAD is seeking marketing approval in the European Union of ponatinib
in adult patients with resistant or intolerant chronic myeloid leukemia
(CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia
(Ph+ ALL). The Committee for Medicinal Products for Human Use (CHMP) has
granted ARIAD's request for accelerated assessment of the MAA.


"The accelerated assessment granted to our MAA further illustrates the
major unmet medical need among patients with CML and Ph+ ALL who have
become resistant or intolerant to prior tyrosine kinase inhibitor
therapy," stated Harvey
J. Berger, M.D., chairman and chief executive officer of ARIAD. "As
we establish our European headquarters in Lausanne, Switzerland and
develop our commercial infrastructure in the region, our regulatory team
will continue to work closely with the EMA as it reviews our data and
the submission, potentially along an accelerated timeline."


Results from the ongoing PACE trial of ponatinib reported in June at
this year's annual meeting of the American Society of Clinical Oncology,
and included in the MAA, showed that 54 percent of chronic-phase CML
patients who were resistant or intolerant to prior tyrosine kinase
inhibitor therapy in the trial, including 70 percent of patients who
have a T315I mutation, achieved a major cytogenetic response (MCyR) -
the primary endpoint of the trial. Thirty percent of these same patients
achieved a major molecular response (MMR). MMR is the primary endpoint
of ARIAD's ongoing Phase 3 EPIC trial comparing ponatinib to imatinib in
newly diagnosed chronic-phase CML patients.


About Ponatinib


Internally discovered at ARIAD, ponatinib is an investigational BCR-ABL
inhibitor that also selectively inhibits certain other tyrosine kinases
in preclinical studies, including FLT3, RET, KIT, and the members of the
FGFR and PDGFR families of kinases. A New Drug Application for ponatinib
was submitted to the U.S. Food and Drug Administration on July 30, 2012.


The primary target for ponatinib is BCR-ABL, an abnormal tyrosine kinase
that is expressed in chronic myeloid leukemia (CML) and
Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
Ponatinib was designed using ARIAD's computational and structure-based
drug design platform to inhibit the activity of BCR-ABL with very high
potency and broad specificity. Ponatinib targets not only native BCR-ABL
but also its isoforms that carry mutations that confer resistance to
treatment with existing tyrosine kinase inhibitors, including the T315I
mutation for which no effective therapy currently exists.


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 or 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. Because both of these diseases express the BCR-ABL protein,
this would render them potentially susceptible to treatment with
ponatinib.


About ARIAD


ARIAD Pharmaceuticals, Inc. is an emerging global oncology company
focused on the discovery, development and commercialization of medicines
to transform the lives of cancer patients. ARIAD's approach to
structure-based drug design has led to several internally discovered,
molecularly targeted product candidates for drug-resistant or
difficult-to-treat cancers, including chronic myeloid leukemia and
certain forms of non-small cell lung cancer. For additional information,
visit http://www.ariad.com
or follow ARIAD on Twitter
(@ARIADPharm).


This press release contains "forward-looking statements" including, but
not limited to, statements relating to the clinical data for ponatinib,
submission, review, and potential approval of the MAA, and timing of
other regulatory filings for marketing approvals. Forward-looking
statements 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 risks and
uncertainties include, but are not limited to, preclinical data and
early-stage clinical data that may not be replicated in later-stage
clinical studies, the costs associated with our research, development,
manufacturing and other activities, the conduct, timing and results of
pre-clinical and clinical studies of our product candidates, the
adequacy of our 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. The Company does not intend to update any of the
forward-looking statements after the date of this document to conform
these statements to actual results or to changes in the Company's
expectations, except as required by law.





Source: ARIAD Pharmaceuticals, Inc.


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