-----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, T+d8lRmWtZA0pMOrBJ4/5bfnPXdjuoWG++yaLNARAWg3dtUz+Nwq2c2gCScxO/Y5 7c403iD5MiCzkpz7nTuI7Q== 0001157523-04-008890.txt : 20040930 0001157523-04-008890.hdr.sgml : 20040930 20040930085848 ACCESSION NUMBER: 0001157523-04-008890 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040930 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20040930 DATE AS OF CHANGE: 20040930 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: 041054114 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 a4730260.txt ARIAD PHARMACEUTICALS 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): September 30, 2004 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 September 30, 2004, ARIAD Pharmaceuticals, Inc. announced initiation of enrollment of patients with bone and soft tissue sarcomas in the first multicenter Phase 2 clinical trial of its novel mTOR inhibitor, AP23573, as a single agent in solid tumors. 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 September 30, 2004. 2 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 and Chief Financial Officer Date: September 30, 2004 3 EXHIBIT INDEX ------------- Exhibit Number Description - ------ ----------- 99.1 Press release dated September 30, 2004. 4 EX-99.1 2 a4730260ex99.txt EXHIBIT 99.1 PRESS RELEASE EXHIBIT 99.1 ------------ ARIAD Initiates Phase 2 Clinical Trial of AP23573 in Patients with Relapsed and/or Refractory Sarcomas CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sept. 30, 2004-- First global multicenter Phase 2 clinical trial of AP23573 in solid tumors ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced initiation of enrollment of patients with bone and soft tissue sarcomas in the first multicenter Phase 2 clinical trial of its novel mTOR inhibitor, AP23573, as a single agent in solid tumors. This non-randomized study will evaluate the clinical benefit of AP23573 in four well-defined groups of sarcoma patients, characterized by tumor type. Up to approximately 175 patients will be enrolled in the trial at approximately 15 centers in the United States and Europe. AP23573 will be administered using a daily dosing regimen of drug. "In our nearly completed Phase 1 clinical trials reported today at the EORTC international cancer symposium, all evaluable patients with relapsed and/or refractory sarcoma had evidence of anti-tumor activity - - a promising result that supports our decision to further evaluate AP23573 in this patient population in Phase 2," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "Despite advancements in anti-cancer therapy, currently available treatment options for such patients are extremely limited due the highly resistant nature of this cancer. Sarcoma remains a disease with high unmet medical need." The study will also include use of pharmacodynamic and pharmacogenomic biomarkers, including functional imaging, to assess the effects of AP23573 on the mTOR pathway and to help identify patients who are likely to benefit most from treatment with AP23573. About Sarcoma Sarcomas are cancers of the connective tissue, including bones, muscles, fat, cartilage, and joints. Sarcomas can arise anywhere in the body and are divided into two main groups - bone tumors and soft tissue sarcomas. They are further sub-classified based on the type of cell found in the tumor. All sarcomas share certain pathologic characteristics. There are approximately 10,000 new cases of sarcoma diagnosed each year in the United States and close to 40,000 sarcoma patients being treated in the United States and Europe. More information about sarcomas is available on the web at http://www.sarcoma.net/facts.htm and at http://www.sarcomafoundation.com/master.html?Articleld=90. About AP23573 The small-molecule drug, AP23573, starves cancer cells and shrinks tumors by inhibiting the critical cell-signaling protein, mTOR, which regulates the response of tumor cells to nutrients and growth factors, and controls tumor blood supply and angiogenesis through effects on Vascular Endothelial Growth Factor (VEGF). 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. ARIAD also 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. Some of the matters discussed herein are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are identified by the use of words such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Such statements are based on management's current 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 forward-looking statements. These risks include, but are not limited to, risks and uncertainties regarding the Company's ability to accurately estimate the actual research and development expenses and other costs associated with the preclinical and clinical development of our product candidates, the adequacy of our capital resources and the availability of additional funding, risks and uncertainties regarding the Company's ability to successfully conduct preclinical and clinical studies of its product candidates, including those clinical trials noted in this press release, risks and uncertainties that clinical trial results at any phase of development may be adverse or may not be predictive of future result or lead to regulatory approval of any of the Company's product candidates, and risks and uncertainties relating to regulatory oversight, intellectual property claims, the timing, scope, cost and outcome of legal proceedings, future capital needs, key employees, dependence on the Company's collaborators and manufacturers, markets, economic conditions, products, services, prices, reimbursement rates, competition and other risks detailed in the Company's public filings with the Securities and Exchange Commission, including ARIAD's Annual Report on Form 10-K for the fiscal year ended December 31, 2003. 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. Tom Pearson, 610-407-9260 or Kelly Lindenboom, 617-621-2345 -----END PRIVACY-ENHANCED MESSAGE-----