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): September
24, 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 September 26, 2011 ARIAD Pharmaceuticals, Inc. (“Company”) issued a press release announcing long-term results of the Phase 1 study of its investigational pan-BCR-ABL inhibitor, ponatinib, in heavily pretreated patients with resistant and refractory chronic myeloid leukemia (CML) and Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL). With the trial fully enrolled and all patients evaluable, 72% of chronic-phase CML patients treated with ponatinib achieved a major cytogenetic response (MCyR), including 92% of patients who also had a T315I mutation. Since the last data update from the trial was presented in December, 2010, all chronic-phase CML patients who achieved a MCyR remain in response with no signs of resistance. These data were presented at the international Chronic Myeloid Leukemia foundation (iCMLf) conference sponsored by the European Society of Hematology (ESH) at its 13th Annual Meeting held in Estoril, Portugal on Saturday, September 24, 2011.
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) The following exhibit is filed with this report:
Exhibit |
Description |
99.1 | Press Release dated September 26, 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. |
|||||
Date: |
September 27, 2011 |
By: |
/s/ Edward M. Fitzgerald |
||
Edward M. Fitzgerald |
|||||
Executive Vice President, Chief Financial Officer |
|||||
Exhibit Index
Exhibit Number |
Description |
99.1 |
Press Release dated September 26, 2011. |
3
Exhibit 99.1
ARIAD Announces Long-Term Follow Up of Patients with Drug-Resistant CML Treated with Ponatinib in Phase 1 Trial
~ Continued improvement in anti-leukemic activity and response rates over time
~ Long-term responses to ponatinib persist
ESTORIL, Portugal & CAMBRIDGE, Mass.--(BUSINESS WIRE)--September 26, 2011--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced long-term results of the Phase 1 study of its investigational pan-BCR-ABL inhibitor, ponatinib, in heavily pretreated patients with resistant and refractory chronic myeloid leukemia (CML) and Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL). With the trial fully enrolled and all patients evaluable, 72% of chronic-phase CML patients treated with ponatinib achieved a major cytogenetic response (MCyR), including 92% of patients who also had a T315I mutation. Since the last data update from the trial was presented in December, 2010, all chronic-phase CML patients who achieved a MCyR remain in response with no signs of resistance.
These data were presented at the international Chronic Myeloid Leukemia foundation (iCMLf) conference sponsored by the European Society of Hematology (ESH) at its 13th Annual Meeting held in Estoril, Portugal on Saturday, September 24, 2011.
“These new data provide further clinical evidence of the striking anti-leukemic activity of ponatinib in a larger number of patients. The response rates to ponatinib continue to improve over time and, importantly, have been shown to be durable in this heavily pretreated patient group that has failed multiple prior therapies for CML,” stated Jorge Cortes, M.D., professor and deputy chair, Department of Leukemia, The University of Texas M.D. Anderson Cancer Center. “It should also be noted that the response rate is higher in patients who have received fewer prior therapies. This suggests that there is great potential for ponatinib to be explored in patients earlier in the course of their disease.”
Updated Results Presented at iCMLf
Note: presentation slides on the updated ponatinib data can be found on the investor page of www.ariad.com.
“These results reaffirm sustained durable responses to ponatinib with median time on ponatinib treatment still not reached among chronic-phase patients, as well as response rates that are remarkable in this refractory patient population,” said Frank G. Haluska, M.D., Ph.D., vice president and chief medical officer of ARIAD.“Importantly, the data show no new significant safety findings on ponatinib and provide further evidence that ponatinib continues to be well tolerated across therapeutic dose levels including at the 45 mg dose being studied in the pivotal PACE trial,” added Dr. Haluska.
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. 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
Liza Heapes, 617-621-2315
Liza.heapes@ariad.com