-----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, VwY8f6/8Prt8CuNZVJTnWXUKm7ExTEP/OKKV4Ed5JOKoiFxDctd13P+2lHpfI7O0 tT9h2/youqJf83/AQ2TGmA== 0001157523-05-005080.txt : 20050611 0001157523-05-005080.hdr.sgml : 20050611 20050526074045 ACCESSION NUMBER: 0001157523-05-005080 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050526 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050526 DATE AS OF CHANGE: 20050526 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: 05858177 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 a4897395.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): May 26, 2005 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 May 26, 2005, ARIAD Pharmaceuticals, Inc. announced initiation of enrollment of patients with relapsed and/or refractory cancers in the first multi-center Phase 1b clinical trial of the oral dosage form of its novel mTOR inhibitor, AP23573, which was recently designated as a fast-track product by the U.S. Food and Drug Administration for the treatment of sarcomas. Oral administration (tablets) should permit greater flexibility in dosing and greater convenience for patients, reducing dependency on a hospital or clinic based treatment regimen. 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 May 26, 2005. 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: May 26, 2005 3 EXHIBIT INDEX ------------- Exhibit Number Description - ------- ----------- 99.1 Press release dated May 26, 2005. 4 EX-99.1 2 a4897395ex991.txt EXHIBIT 99.1 - PRESS RELEASE EXHIBIT 99.1 ARIAD Initiates First Clinical Trial of Oral AP23573 in Patients with Relapsed and/or Refractory Cancers CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 26, 2005-- Study Focuses On Safety, Dosing, Anti-cancer Activity and Bioavailability ARIAD Pharmaceuticals, Inc. (Nasdaq:ARIA) today announced initiation of enrollment of patients with relapsed and/or refractory cancers in the first multi-center Phase 1b clinical trial of the oral dosage form of its novel mTOR inhibitor, AP23573, which was recently designated as a fast-track product by the U.S. Food and Drug Administration for the treatment of sarcomas. Oral administration (tablets) should permit greater flexibility in dosing and greater convenience for patients, reducing dependency on a hospital or clinic based treatment regimen. This non-randomized, dose-escalation study will evaluate the safety, anti-cancer activity, pharmacokinetics, and bioavailability of AP23573 tablets administered in three different oral dosing regimens. Up to approximately 150 cancer patients will be enrolled in the trial at three to five leading cancer centers in the United States. An intravenous dosage form of AP23573 is currently being studied in multiple Phase 2 and 1b clinical trials in patients with hematologic malignancies and solid tumors, including bone and soft-tissue sarcomas, prostate, breast, ovarian, non-small-cell lung and brain cancers. In studies conducted to date, AP23573 has exhibited a favorable safety profile and broad anti-cancer activity. "The initiation of patient enrollment in the first clinical trial of our newly developed oral dosage form of AP23573 represents another major milestone for ARIAD," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "Based on the clinical results and patient benefit seen to date with the intravenous form of AP23573, we expect to move quickly through this oral bridging study which should allow us to proceed with one or both dosage forms in key registration trials." "The availability of both dosage forms should provide added flexibility and therapeutic options as we develop AP23573 as a fast-track product for patients with sarcoma," said Camille L. Bedrosian, chief medical officer of ARIAD. 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) in tumor and endothelial cells. AP23573 also blocks the proliferation and migration of vascular smooth muscle cells, the primary cause of narrowing and reblockage of injured arteries, and is an analog of sirolimus, another mTOR inhibitor that has been approved for use in drug-eluting stents. AP23573 is currently in Phase 1 and 2 clinical trials in patients with solid tumors and hematologic cancers. AP23573 has been designated a fast-track product by the U.S. Food and Drug Administration for the treatment of soft tissue and bone sarcomas. About ARIAD ARIAD is engaged in the discovery and development of breakthrough medicines to treat disease 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. 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 timing and actual research and development expenses and other costs associated with the preclinical and clinical development and manufacture of our product candidates, the adequacy of our capital resources and the availability of additional funding, risks and uncertainties regarding our ability to manufacture our product candidates on a commercial scale or to supply our product candidates to our collaborator for use in its product candidates, risks and uncertainties regarding our and our collaborator's ability to successfully enroll and conduct preclinical and clinical studies of product candidates, including our product candidate to treat cancer described in this release and our collaborator's medical device product candidates to treat vascular disease, risks and uncertainties that clinical trial results at any phase of development may be adverse or may not be predictive of future results or lead to regulatory approval of any of our or our collaborator's product candidates, risks and uncertainties of third-party intellectual property claims relating to our and our collaborator's product candidates, and risks and uncertainties relating to regulatory oversight, the timing, scope, cost and outcome of legal proceedings, including litigation concerning our NF-(kappa)B patent portfolio, future capital needs, key employees, dependence on our 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, as amended, for the fiscal year ended December 31, 2004. 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. Investors: Tom Pearson, 617-621-2345 or Media: Pure Communications: Andrea Johnston, 910-681-1088 -----END PRIVACY-ENHANCED MESSAGE-----