-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, SSguHWOiOCIFBmAXjCC2NxRWqe+4U5H+fbSUCtLDcinRXQ93J7gufKt9JMNXFJWr vxtb6gCbFqdT480XxnpZsQ== 0001157523-07-005813.txt : 20070604 0001157523-07-005813.hdr.sgml : 20070604 20070604100342 ACCESSION NUMBER: 0001157523-07-005813 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070603 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070604 DATE AS OF CHANGE: 20070604 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ARIAD PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000884731 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 223106987 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21696 FILM NUMBER: 07895957 BUSINESS ADDRESS: STREET 1: 26 LANDSDOWNE ST CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6174940400 MAIL ADDRESS: STREET 1: 26 LANDSDOWNE CITY: CAMBRIDGE STATE: MA ZIP: 02139 8-K 1 a5416994.txt ARIAD PHARMACEUTICALS, INC. 8-K 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 3, 2007 ARIAD Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 0-21696 22-3106987 (State or other jurisdiction (Commission (I.R.S. Employer of incorporation) File Number) 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. In a press release dated June 3, 2007, ARIAD Pharmaceuticals, Inc. announced additional positive efficacy data on AP23573 - its novel mTOR inhibitor - from further analysis of its ongoing Phase 2 trial of AP23573 in patients with metastatic and/or unresectable soft-tissue and bone sarcomas. The expanded analysis focuses on the 60 patients with an AP23573 clinical-benefit response (CBR) - the primary endpoint of the 212-patient trial - and its relationship to overall survival. The new results demonstrate that documented disease stabilization and/or tumor regression with single-agent AP23573 is a strong predictor of improved overall survival. A copy of the press release is filed herewith as Exhibit 99.1 and the information contained therein is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K. ITEM 9.01 Financial Statements and Exhibits. (c) The following exhibits are filed with this report Exhibit Number Description ------ ----------- 99.1 Press release dated June 3, 2007 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 Senior Vice President, Finance and Corporate Operations, Chief Financial Officer Date: June 4, 2007 EXHIBIT INDEX ------------- Exhibit Number Description - ------ ----------- 99.1 Press release dated June 3, 2007 EX-99.1 2 a5416994ex99-1.txt EXHIBIT 99.1 Exhibit 99.1 ARIAD Presents Additional Efficacy Data on AP23573, Novel mTOR Inhibitor, in Phase 2 Advanced Sarcoma Trial AP23573 Clinical-Benefit Response Is a Strong Predictor of Improved Overall Survival CHICAGO & CAMBRIDGE, Mass.--(BUSINESS WIRE)--June 3, 2007--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced additional positive efficacy data on AP23573 - its novel mTOR inhibitor - from further analysis of its ongoing Phase 2 trial of AP23573 in patients with metastatic and/or unresectable soft-tissue and bone sarcomas. The expanded analysis focuses on the 60 patients with an AP23573 clinical-benefit response (CBR) - the primary endpoint of the 212-patient trial - and its relationship to overall survival. The new results demonstrate that documented disease stabilization and/or tumor regression with single-agent AP23573 is a strong predictor of improved overall survival. Patients with an AP23573 CBR - tumor regression or disease stabilization for at least 16 weeks - had a median overall survival of approximately 17 months, nearly double that of the overall trial population (vs. approximately 9 months). Cox regression analyses performed using a series of potential predictors of survival showed that CBR was the best predictor of survival among all variables tested. "These results provide further evidence of the beneficial effects of AP23573 in patients with advanced sarcomas and demonstrate that the disease stabilization and tumor regression responses achieved with AP23573 in this patient population led to clinically meaningful prolongation of overall survival," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "We are continuing to move rapidly to launch our randomized, worldwide Phase 3 clinical trial of oral AP23573 in patients with metastatic sarcomas in the third quarter of this year." Sant Chawla, M.D., co-principal investigator of the study, presented the results at the 43rd annual meeting of the American Society of Clinical Oncology in Chicago, IL. Camille L. Bedrosian, M.D., chief medical officer of ARIAD, added, "the data from the overall survival analysis of the Phase 2 trial further support our Phase 3 trial design and strategy, which focuses on metastatic sarcoma patients who have experienced a favorable response to prior chemotherapy and have at least stable disease. We believe this well-defined patient population has the greatest likelihood of achieving sustained clinical benefit from treatment with a new molecularly targeted agent such as AP23573." Advanced Sarcoma Phase 2 Trial Design and Previously Reported Results At previous meetings, ARIAD announced that AP23573 demonstrated efficacy and was well tolerated as a single agent in this multi-center Phase 2 trial of patients with advanced sarcomas, at least 90% of whom had progressive disease. The efficacy of AP23573 was evaluated using two closely related measures of disease progression: CBR (characterized as tumor regression - complete regression or partial response - or disease stabilization for at least four cycles by RECIST guidelines), and progression-free survival (PFS, reported as the six-month rate and the median duration). The primary end-point of the trial - evidenced by CBR rates - was achieved in the three most prevalent types of sarcomas (i.e., bone sarcoma, leiomyosarcoma, and liposarcoma), and treatment with AP23573 more than doubled PFS when compared to historical control data from the European Organization for Research and Treatment of Cancer (EORTC). Sixty-one of the 212 patients in the trial achieved an AP23573 CBR; these patients had a PFS rate at six months of 70% and median PFS of 36 weeks. The PFS rate in this patient subset was nearly triple that of the overall population (vs. 24%), and the median PFS was approximately 21 weeks longer than that of the overall trial population (vs. 15 weeks). About AP23573 ARIAD's lead product candidate, AP23573, is a novel small-molecule inhibitor of the protein mTOR, a "master switch" in cancer cells. Blocking mTOR creates a starvation-like effect in cancer cells by interfering with cell growth, division, metabolism, and angiogenesis. AP23573 is currently in Phase 1 and 2 clinical trials in patients with solid tumors and hematologic cancers. AP23573 has been designated both as a fast-track product and an orphan drug by the U.S. Food and Drug Administration and as an orphan drug by the European Medicines Agency for the treatment of soft-tissue and bone sarcomas. In addition to its program in oncology, ARIAD is collaborating with Medinol Ltd. to develop stents and other medical devices that deliver AP23573 to prevent reblockage at sites of vascular injury following stent-assisted angioplasty. About ARIAD ARIAD is engaged in the discovery and development of breakthrough medicines to treat cancer by regulating cell signaling with small molecules. The Company is developing a comprehensive approach to patients with cancer that addresses the greatest medical need - aggressive and advanced-stage cancers for which current treatments are inadequate. Medinol Ltd. also is developing stents and other medical devices that deliver ARIAD's lead cancer product candidate to prevent reblockage at sites of vascular injury following stent-assisted angioplasty. ARIAD has an exclusive license to pioneering technology and patents related to certain NF-(kappa)B treatment methods, and the discovery and development of drugs to regulate NF-(kappa)B cell-signaling activity, which may be useful in treating certain diseases. Additional information about ARIAD can be found on the web at http://www.ariad.com. This press release contains "forward-looking statements," including statements related to the efficacy of AP23573 and the initiation of our Phase 3 clinical trial of AP23573 in metastatic sarcomas in the third quarter of 2007. 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, the costs associated with our research, development, manufacturing and other activities, the conduct and results of pre-clinical and clinical studies of our product candidates, difficulties or delays in obtaining regulatory approvals to market products resulting from our development efforts, our reliance on partners and other key parties for the successful development, manufacturing and commercialization of products, the adequacy of our capital resources and the availability of additional funding, patent protection and third-party intellectual property claims relating to our and any partner's product candidates, the timing, scope, cost and outcome of legal and patent office proceedings concerning our NF-(kappa)B patent portfolio, the potential acquisition of or other strategic transaction regarding the minority stockholders' interests in our 80%-owned subsidiary, ARIAD Gene Therapeutics, Inc., future capital needs, key employees, markets, economic conditions, prices, reimbursement rates, competition and other factors detailed in the Company's public filings with the U.S. Securities and Exchange Commission. The information contained in this document 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. Edward M. Fitzgerald, 617-621-2345 or Pure Communications Andrea L. Johnston, 910-616-5858 -----END PRIVACY-ENHANCED MESSAGE-----