-----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, WC/xdp4pXBaPqw4dEntrrfGjL5E2cOaM1ZXHp3hR3T8w8hXAwdQXlgNqpM8ByvJf L38jO+zUchE6zaMcMC06ow== 0001157523-04-002783.txt : 20040330 0001157523-04-002783.hdr.sgml : 20040330 20040330080659 ACCESSION NUMBER: 0001157523-04-002783 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040330 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20040330 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: 333-76486 FILM NUMBER: 04698070 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 a4604182.txt ARIAD PHARMACEUTICALS 8-K 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): March 30, 2004 ARIAD PHARMACEUTICALS, INC. -------------------------- (Exact Name of Registrant as Specified in its Charter) Delaware 0-21696 22-3106987 -------- ------- ---------- (State or Other Jurisdiction (Commission File Number) (I.R.S. Employer of Incorporation) Identification No.) 26 LANDSDOWNE STREET CAMBRIDGE, MASSACHUSETTS 02139 (Address of principal executive offices and zip code) Registrant's telephone number, including area code: (617) 494-0400 ITEM 5. OTHER EVENTS On March 30, 2004, the Registrant disseminated a Press Release announcing results of preclinical studies showing that its lead mTOR inhibitor, AP23573, augments the anti-cancer activity of widely used cytotoxic and new anti-cancer agents when given in combination. Included in the studies are the molecularly targeted drugs, imatinib (Gleevec(TM)), trastuzumab (Herceptin(R)) and an EGFR inhibitor, as well as the chemotherapy drugs, docetaxel, doxorubicin, cisplatin and topotecan. The information contained in the Press Release dated March 30, 2004, is incorporated herein by reference and attached as Exhibit 99.1 hereto. ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS. (c) Exhibits. 99.1 The Registrant's Press Release dated March 30, 2004. 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 thereunto duly authorized. ARIAD PHARMACEUTICALS, INC. By: /s/ Edward M. Fitzgerald ------------------------ Edward M. Fitzgerald Senior Vice President and Chief Financial Officer Date: March 30, 2004 2 EXHIBIT INDEX ------------- Exhibit Number Description Sequential Page Number - ------- ----------- ---------------------- 99.1 The Registrant's Press Release dated March 30, 2004. 4 3 EX-99.1 3 a4604182ex99.txt EXHIBIT 99.1 PRESS RELEASE Exhibit 99.1 ARIAD's Lead Oncology Product, AP23573, Effective in Combination with Widely Used Anti-Cancer Agents CAMBRIDGE, Mass.--(BUSINESS WIRE)--March 30, 2004--ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced results of preclinical studies showing that its lead mTOR inhibitor, AP23573, augments the anti-cancer activity of widely used cytotoxic and new anti-cancer agents when given in combination. Included in the studies are the molecularly targeted drugs, imatinib (Gleevec(TM)), trastuzumab (Herceptin(R)) and an EGFR inhibitor, as well as the chemotherapy drugs, docetaxel, doxorubicin, cisplatin and topotecan. Phase 1 clinical trials of AP23573 in patients with advanced cancers are currently underway, and phase 2 studies are expected to begin in second quarter 2004. This research - being presented today at the American Association for Cancer Research annual meeting supports the use of AP23573 in multi-drug regimens for treating specific cancers, including breast, ovarian and endometrial solid tumors and leukemia. "Optimally designing clinical trials may well be the single most important factor in ensuring the success of a newly developed drug candidate," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "In planning the expanded clinical program for AP23573, we have been rigorous in generating and analyzing key preclinical and clinical data for selecting the most appropriate indications and drug regimens." The abstract by Victor M. Rivera, et al, "Anti-proliferative activity of the mTOR inhibitor AP23573 in combination with cytotoxic and targeted agents," is available on the AACR website (http://www.aacr.org/2004AM/2004AM.asp). Gleevec is a trademark of Novartis AG. Herceptin is a registered trademark of Genentech, Inc. 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 conduct preclinical and clinical studies of its product candidates and the results of such studies, 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 Kathy Lawton, 617-621-2345 -----END PRIVACY-ENHANCED MESSAGE-----