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): June
4, 2012
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 June 4, 2012, ARIAD Pharmaceuticals, Inc. issued a press release announcing updated clinical data from the pivotal PACE trial 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 data show that 54 percent of chronic-phase CML patients in the trial, including 70 percent of patients who have a T315I mutation, achieved a major cytogenetic response. The PACE trial data were featured in an oral presentation at the 2012 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, IL.
A copy of the press release is being filed herewith as Exhibit 99.1 and the information contained therein is incorporated by reference into this Current Report on Form 8-K.
ITEM 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit | ||
Number |
Description |
|
99.1 | Press release dated June 4, 2012. |
The press release contains hypertext links to information on ARIAD’s website. The information on ARIAD’s website is not incorporated by reference into this Current Report on Form 8-K and does not constitute a part of this Form 8-K.
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 |
|||||
Date: |
June 4, 2012 |
3
Exhibit 99.1
ARIAD Announces Updated Data from Pivotal PACE Trial of Ponatinib, Its Investigational pan-BCR-ABL Inhibitor
~ Robust anti-leukemic activity in CML patients who have become resistant or intolerant to available tyrosine kinase inhibitors
~ 54 percent major cytogenetic response and 30 percent major molecular response reported in heavily pretreated chronic-phase CML patients
~ Investor meeting and webcast to be held today at 12:00 p.m. (CT)
CHICAGO & CAMBRIDGE, Mass.--(BUSINESS WIRE)--June 4, 2012--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced updated clinical data from the pivotal PACE trial 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 data show that 54 percent of chronic-phase CML patients in the trial, including 70 percent of patients who have a T315I mutation, achieved a major cytogenetic response. ARIAD expects to file for regulatory approval of ponatinib in the U.S. and the EU in the third quarter of 2012 based on these clinical data.
The PACE trial data are being featured today at 9:00 a.m. (CT) in an oral presentation at the 2012 American Society of Clinical Oncology (ASCO) annual meeting taking place in Chicago, IL.
“The findings from the global PACE trial of ponatinib confirm its impressive anti-leukemic activity in patients with CML at all stages 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.
“Clinical responses to ponatinib were observed in patients regardless of their mutation status or disease stage,” he added. “Of particular importance, responses to ponatinib appear to be durable, with 93 percent of chronic-phase CML patients projected to remain in major cytogenetic response at one year, clearly highlighting the potency of ponatinib.”
Updated Results Presented at ASCO
“These updated findings of the PACE trial show beneficial responses and an increasing molecular response rate to ponatinib,” said Frank G. Haluska, M.D., Ph.D., senior vice president and chief medical officer of ARIAD. “Importantly, these data provide clear 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,” added Dr. Haluska.
Investor Meeting Today at 12:00 p.m. (CT)
ARIAD will hold an investor meeting and webcast at 12:00 p.m. (CT)/1:00 p.m. (ET) today, Monday, June 4, 2012 to review these data being presented at ASCO. The event will feature Jorge Cortes, M.D., professor and deputy chair, Department of Leukemia, The University of Texas M.D. Anderson Cancer Center. This event is being held at the Chicago Hilton Hotel for ARIAD’s research analysts and for institutional investors attending the ASCO 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 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.
CONTACT:
ARIAD Pharmaceuticals, Inc.
For Investors
Maria
E. Cantor, 617-621-2208
Maria.cantor@ariad.com
or
For
Media
Lynn Granito, 212-253-8881
lgranito@berrypr.com