ARIAD Provides Update on Important Progress Being Made in R&D and Commercial Initiatives

  ARIAD Provides Update on Important Progress Being Made in R&D and Commercial

          More than 325 patients in U.S. now on Iclusig™ (ponatinib)

             Phase 2 cohorts of AP26113 on track to begin 2Q 2013

              Pivotal trial of AP26113 on track to begin 3Q 2013

    EPIC Trial advancing as planned with full enrollment projected 4Q 2013

   Company to host investor call today with analyst questions at 8 a.m. ET

Business Wire

CAMBRIDGE, Mass. -- April 4, 2013

ARIAD Pharmaceuticals, Inc. (NASDAQ: 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
  *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.

“We are nearing completion of the Phase 1 portion of the Phase 1/2 clinical
trial of AP26113 and are committed to advancing a dose and schedule for ‘113
that are optimal and provide the best opportunity for clinical success across
each of the patient groups represented by the cohorts in the ongoing trial,”
stated Harvey J. Berger, M.D., chairman and chief executive officer. “At the
same time, we are very pleased with the progress being made in the U.S.
commercial launch of Iclusig, and we are advancing the Phase 3 EPIC trial as
planned. Each of these is a key value driver for our shareholders, and we are
focused on nothing short of flawless execution.”

First Quarter 2013 Earnings Call Scheduled

ARIAD will host its first quarter 2013 webcast and investor conference call on
Tuesday, May 7 at 8:30 a.m. ET. Additional details regarding the dial-in
information for the call will be provided in the next few weeks.

Today’s Conference Call at 8:00 a.m. ET

We will hold a live webcast and conference call today at 8:00 a.m. ET. The
live webcast can be accessed by visiting the investor relations section of the
Company’s website at The call can be accessed by
dialing 800-884-5695 (domestic) or 617-786-2960 (international) five minutes
prior to the start time and providing the pass code 19013304. A replay of the
call will be available on the ARIAD website approximately two hours after
completion of the call and will be archived for three weeks.

About Iclusig™ (ponatinib) tablets

Iclusig is a kinase inhibitor indicated for the treatment of adult patients
with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia
(CML) that is resistant or intolerant to prior tyrosine kinase inhibitor
therapy or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+
ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor
therapy. This indication is based upon response rate. There are no trials
verifying an improvement in disease-related symptoms or increased survival
with Iclusig.

Important Safety Information for Iclusig™ (ponatinib)


Arterial Thrombosis: Cardiovascular, cerebrovascular, and peripheral vascular
thrombosis, including fatal myocardial infarction and stroke have occurred in
Iclusig-treated patients. In clinical trials, serious arterial thrombosis
occurred in eight percent of Iclusig-treated patients. Interrupt and consider
discontinuation of Iclusig in patients who develop arterial thrombotic events.

Hepatotoxicity: Hepatotoxicity, liver failure and death have occurred in
Iclusig-treated patients. Monitor hepatic function prior to and during
treatment. Interrupt and then reduce or discontinue Iclusig for

Please visit for full prescribing information, including boxed


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.comor follow ARIAD on
Twitter (@ARIADPharm).

This press release contains “forward-looking statements” including, but not
limited to, updates on clinical, preclinical and regulatory developments and
commercialization plans for our product candidates. 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, our ability to successfully launch, commercialize and generate profits
from sales of Iclusig; competition from alternative therapies, our ability to
obtain approval for Iclusig outside of the United States and in additional
indications; our reliance on third-party manufacturers, and on specialty
pharmacies for the distribution of Iclusig; 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 and results of preclinical and clinical studies of our
product candidates; difficulties or delays in obtaining regulatory approvals
to market products; the adequacy of our capital resources and the availability
of additional funding; patent protection and third-party intellectual property
claims; our failure to comply with extensive regulatory requirements; the
occurrence of serious adverse events in patients being treated with Iclusig or
our product candidates; risks related to key employees, markets, economic
conditions, health care reform, prices and reimbursement rates; and other risk
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.


ARIAD Pharmaceuticals, Inc.
Kendra Adams, 617-503-7028
Liza Heapes, 617-621-2315
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