UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): December
11, 2011
ARIAD
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
0-21696 |
22-3106987 |
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
26 Landsdowne Street, Cambridge, Massachusetts |
02139 |
(Address of principal executive offices) |
(Zip Code) |
Registrant's telephone number, including
area code: (617) 494-0400
Not
Applicable
(Former
name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
⃞ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
⃞ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
⃞ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
⃞ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
ITEM 8.01 |
Other Events. |
On December 11, 2011, ARIAD Pharmaceuticals, Inc. issued a press release announcing preliminary clinical data from the pivotal PACE trial -- a fully enrolled and ongoing Phase 2 study of its investigational pan-BCR-ABL inhibitor, ponatinib, in patients with chronic myeloid leukemia (CML) or Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL), who are resistant or intolerant to dasatinib or nilotinib or who have the T315I mutation. These initial data demonstrate that 47 percent of chronic-phase CML patients in the trial achieved a major cytogenetic response to date, including 65 percent of patients who have a T315I mutation. Approximately half of these patients had no more than a single bone-marrow assessment, while the remainder had two or more assessments.
These preliminary data were featured in an oral presentation on December 11, 2011 at the 53rd Annual Meeting of the American Society of Hematology being held in San Diego, CA.
ITEM 9.01 |
Financial Statements and Exhibits |
(d) The following exhibit is filed with this report:
Exhibit |
Description |
99.1 | Press Release dated December 11, 2011. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
ARIAD Pharmaceuticals, Inc. |
|||||
|
|
By: |
/s/ Edward M. Fitzgerald |
||
Edward M. Fitzgerald |
|||||
Executive Vice President, Chief Financial Officer |
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Date: |
December 11, 2011 |
3
Exhibit 99.1
ARIAD Announces Preliminary Data from Pivotal Pace Trial of Ponatinib, Its Investigational pan-BCR-ABL Inhibitor
~ Substantial anti-leukemic activity in CML patients who have become resistant or intolerant to available tyrosine kinase inhibitors
~ Major molecular and complete cytogenetic responses emerging in heavily pretreated patients
~ Investor meeting and webcast to be held tomorrow morning at 7:00 am (PST)
SAN DIEGO, Calif. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--December 11, 2011--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced preliminary clinical data from the pivotal PACE trial -- a fully enrolled and ongoing Phase 2 study of its investigational pan-BCR-ABL inhibitor, ponatinib, in patients with chronic myeloid leukemia (CML) or Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL), who are resistant or intolerant to dasatinib or nilotinib or who have the T315I mutation. These initial data demonstrate that 47 percent of chronic-phase CML patients in the trial achieved a major cytogenetic response to date, including 65 percent of patients who have a T315I mutation. Approximately half of these patients had no more than a single bone-marrow assessment, while the remainder had two or more assessments.
The preliminary data are being featured today at 4:30 p.m. (PST) in an oral presentation at the 53rd Annual Meeting of the American Society of Hematology (ASH) being held in San Diego, CA.
“The preliminary findings from the global PACE trial confirm strong clinical evidence of the anti-leukemic activity of ponatinib in patients who are resistant or intolerant to dasatinib or nilotinib, or who have the T315I mutation for which there are no currently available treatments,” stated Jorge Cortes, M.D., professor and deputy chair, Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, TX.
“These results are very attractive even at this early stage of the study when most patients have only had one or two assessments for cytogenetic response because of the short follow-up,” he added. “We know from the Phase 1 clinical trial of ponatinib that response rates increase over time, and we expect this to be the same on PACE. We are very pleased with the strength of these preliminary data that are similar to initial response results reported in the Phase 1 setting.”
Preliminary Results Presented at ASH
“These preliminary results of the PACE trial show beneficial responses to ponatinib and a molecular response rate that already compares favorably to MMR rates seen with imatinib -- the most commonly used treatment for newly diagnosed CML patients,” said Frank G. Haluska, M.D., Ph.D., vice president and chief medical officer of ARIAD. “The early response rates are highly encouraging, with a 47 percent major cytogenetic response rate in this heavily pretreated patient population with chronic-phase CML, including a 65 percent major cytogenetic response rate in patients with the T315I mutation for whom none of the approved therapies is effective.”
“Importantly, this initial assessment of the PACE trial provides further evidence of a favorable safety and tolerability profile of ponatinib in resistant or intolerant CML patients. The adverse event profile is similar to what was seen in the earlier Phase 1 study of ponatinib, although the incidence of pancreatitis is less in the PACE trial. The four deaths that were deemed to be treatment related were likely linked to the advanced nature of their disease, including the myelosuppressive effects of ponatinib on already badly damaged bone marrows,” added Dr. Haluska.
Investor Meeting Tomorrow at 7 am (PST)
ARIAD will hold an investor meeting and webcast at 7:00 am (PST) on Monday, December 12, 2011 to review these data being presented at ASH. The event will feature Moshe Talpaz, M.D., Associate Director of Translational Research and Associate Chief of Hematologic Malignancies, Trotman Professor of Leukemia Research at the University of Michigan Medical Center. Dr. Talpaz is an investigator in the Phase 1 and Phase 2 trials of ponatinib. This event is being held at the Westin Gaslamp Quarter Hotel for ARIAD’s research analysts and for institutional investors attending the ASH conference and will be webcast live on the investor relations page of the Company's website at http://investor.ariad.com
A replay of this investor event will be available on the ARIAD website approximately three hours after the presentation and will be archived for four weeks. To ensure a timely connection to the live webcast, participants should log onto the webcast at least fifteen minutes prior to the scheduled start time.
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 more aggressive phases such as accelerated 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 three internally discovered, molecularly targeted product candidates for drug-resistant and difficult-to-treat cancers, including certain forms of chronic myeloid leukemia, soft tissue and bone sarcomas and non-small cell lung cancer. For additional information, visit http://www.ariad.com.
This press release contains “forward-looking statements” including, but not limited to, statements relating to the updated clinical data for ponatinib, the positive treatment effects of ponatinib over time and the timing of future data analyses. 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.
CONTACT:
For Investors
Maria E. Cantor, 617-621-2208
Maria.cantor@ariad.com
or
For
Media
Liza Heapes, 617-621-2315
Liza.heapes@ariad.com