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| ARIAD Completes Rolling Submission of New Drug Application for Ponatinib to the U.S. Food and Drug Administration |
“In late July, we submitted the NDA for ponatinib ahead of schedule and,
at the request of the
ARIAD anticipates approval and commercial launch of ponatinib in the
U.S. in the first quarter of 2013. Also, the Marketing Authorization
Application (MAA) for ponatinib, submitted in August, has been validated
by the 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.
The primary target for ponatinib is BCR-ABL, an abnormal tyrosine kinase
that is expressed in chronic myeloid leukemia (CML) and
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
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 NDA, 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 Source:
ARIAD Pharmaceuticals, Inc. |