ARIAD Pharmaceuticals, Inc. ARIA today provided an update on its
progress over the past several weeks with both the commercial launch of
Iclusig™ (ponatinib) in the United States and the clinical development
programs for Iclusig and AP26113. We are providing this update to further
clarify our recent news announcements and to respond to investor questions.
Global Commercialization of Iclusig
* In the first twelve weeks since commercial launch of Iclusig in the U.S.
(through March 2013), there now are more than 225 unique prescribers of
Iclusig and nearly 200 unique accounts using Iclusig.
* More than 325 patients in the U.S. are now being treated with Iclusig
obtained commercially based on physicians' prescriptions. Importantly,
this does not include any patients using the initial Quick Start 30-day
supply.
* Approximately 65 percent of prescribers are now community-based
physicians, with the remainder based in the academic setting. We expect
that adoption of Iclusig among community physicians will continue to
increase as the ongoing launch progresses.
* Nearly all of the patients enrolled in the U.S. expanded access program
for Iclusig have now transitioned to commercial supply, with many still
using the initial Quick Start supply.
* In March 2013, the Committee for Human Medicinal Products (CHMP) of the
European Medicines Agency (EMA) adopted a positive opinion for full
approval of Iclusig for two indications. The positive recommendation by
the CHMP of Iclusig for use in chronic myeloid leukemia (CML) and
Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ALL)
provides a broad indication statement for Iclusig in resistant and
intolerant patients, including many patients who have failed only one
prior tyrosine kinase inhibitor.
* When adopted by the European Commission, Iclusig will be indicated in the
second-line setting in patients who are resistant to dasatinib or
nilotinib, or who have the T315I mutation of BCR-ABL. Company and
independent research shows that approximately 40 percent of chronic-phase
patients and approximately 50 percent of advanced-phase patients with
newly diagnosed CML are receiving dasatinib or nilotinib as their initial
tyrosine kinase inhibitor treatment. We expect these percentages to
continue to increase as the two second-generation therapies achieve
greater adoption in Europe, as they have done in the U.S.
* We anticipate approval of Iclusig in the EU in the second quarter of 2013
and regulatory submissions in Canada, Switzerland, and Australia in the
third quarter of 2013. We are committed to being launch-ready in Europe by
July 1, 2013.
Broadening Iclusig Clinical Development
* The global, Phase 3 EPIC trial of Iclusig, which compares Iclusig to
imatinib in patients with newly diagnosed CML, is advancing with full
patient enrollment on track for completion in the fourth quarter of 2013.
Approximately 120 clinical sites in 20 countries are now participating in
the trial, and data from an interim analysis are anticipated in mid-2014.
* An experienced Data Monitoring Committee (DMC) that is chartered in the
clinical protocol and is chaired by a well-known academic oncologist is
overseeing the conduct of the EPIC trial. The DMC has met and reviewed the
data from the study thus far, as stipulated in the protocol. The EPIC
trial continues as planned.
Advancing AP26113
* The Phase 1 portion of our Phase 1/2 clinical trial of AP26113 is ongoing,
and we expect to transition into the four Phase 2 expansion cohorts,
including the one designated for patients with EGFR-mutant non-small cell
lung cancer (NSCLC), in the second quarter of 2013.
* A fifth Phase 2 cohort in ALK-positive NSCLC patients with brain
metastases is also being planned.
* We will advance a dose and schedule for AP26113 in the Phase 2 cohorts
that are appropriate based on safety, tolerability, and pharmacokinetics
(i.e., circulating trough plasma levels of AP26113).
* In parallel to the Phase 2 expansion cohorts, we plan to begin enrollment
in a pivotal trial of AP26113 in ALK-positive NSCLC patients who are
resistant to crizotinib in the third quarter of 2013.
* We will present clinical updates on AP26113 at the 2013 annual meetings of
the American Society of Clinical Oncology in June and the European Society
of Medical Oncology in September.
* We will also apply for Breakthrough Designation status for AP26113 with
the U.S. Food and Drug Administration. This designation is not required in
advance of the start of the pivotal trial of AP26113.
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