-----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, HVTbJNF8aYCgvZZ6bMiqks8piV19ZIKEkjomVdkbA8BQx1DPeUxwVa6LScQKQgCY 0SxVNnRBM1HIJaljFIjFdA== 0001157523-07-009818.txt : 20071015 0001157523-07-009818.hdr.sgml : 20071015 20071015124801 ACCESSION NUMBER: 0001157523-07-009818 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20071009 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071015 DATE AS OF CHANGE: 20071015 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: 071171414 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 a5514885.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): October 9, 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 1.01 Entry into a Material Definitive Agreement On October 9, 2007, ARIAD Pharmaceuticals, Inc. (the "Registrant"), along with its 80%-owned subsidiary, ARIAD Gene Therapeutics, Inc. (together, the "Company"), entered into a non-exclusive license agreement with ICON Medical Corp. ("ICON"), an emerging cardiovascular medical device company, to develop and commercialize drug-eluting stents that deliver ARIAD's novel mTOR inhibitor, deforolimus (the "Products"), to prevent restenosis of injured vessels following interventions in which stents are used in conjunction with balloon angioplasty. Under the license agreement, the Company granted to ICON a non-exclusive, worldwide, royalty-bearing license, under its patents and technology, to develop, manufacture and sell the Products. The term of the license agreement extends to the later to occur of the expiration of the Company's patents related to the rights granted to ICON under the license agreement or fifteen years after the first commercial sale of a Product. ICON is required under the license agreement to use commercially reasonable efforts to develop the Products. The license agreement provides that the Company will receive an equity stake in ICON pursuant to a Stock Purchase Agreement, up to $27 million in payments based on achievement of certain clinical, regulatory and commercial milestones for two products and royalties on worldwide sales of all Products. The Company is required to use commercially reasonable efforts to supply deforolimus to ICON for use in the development, manufacture and sale of the Products. The license agreement may be terminated by either party for breach after a cure period of up to 90 days, in the case of bankruptcy by either party, by ICON upon 30 days prior written notice if ICON determines, in its reasonable business judgment, that it is not in its business interest to continue development of any Product, or by the Company upon 30 days' prior written notice, if it determines that it is not in its business interest to continue development and regulatory approval efforts with respect to deforolimus. A copy of the press releaseannouncing the collaboration, dated October 11, 2007, is filed herewith as Exhibit 99.1 and the information contained therein is incorporated by reference into this Item 1.01 of this Current Report on Form 8-K. ITEM 9.01 Financial Statements and Exhibits. (d) The following exhibits are filed with this report Exhibit Number Description ------ ----------- 99.1 Press release dated October 11, 2007 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, Finance and Corporate Operations, Chief Financial Officer Date: October 15, 2007 3 EXHIBIT INDEX ------------- Exhibit Number Description - ------ ----------- 99.1 Press release dated October 11, 2007 4 EX-99.1 2 a5514885ex991.txt EXHIBIT 99.1 Exhibit 99.1 ARIAD Announces Collaboration with ICON Medical to Develop and Commercialize Novel Deforolimus-Eluting Stents Agreement Further Highlights Therapeutic Value of ARIAD's Novel mTOR Inhibitor CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 11, 2007--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it has entered into a non-exclusive license agreement with ICON Medical Corp., an emerging cardiovascular medical device company, to develop and commercialize drug-eluting stents that deliver ARIAD's novel mTOR inhibitor, deforolimus, to prevent restenosis of injured vessels following interventions in which stents are used in conjunction with balloon angioplasty. Inhibitors of mTOR block the wound-healing response to arterial injury that leads to restenosis. As part of the agreement, ARIAD will receive an equity stake in ICON, up to $27 million in payments based on achievement of certain clinical, regulatory and commercial milestones for two products and royalties on worldwide sales of all ICON medical devices delivering deforolimus. ICON will be responsible for the development and commercialization of these medical devices, and ARIAD will supply deforolimus to ICON for use in these devices. Additional terms were not disclosed. ARIAD has retained the right to enter into one additional non-exclusive license agreement, in addition to the licenses granted to ICON and Medinol Ltd., to develop and commercialize medical devices delivering deforolimus for use in vascular disease. "ICON is one of the most innovative and promising medical device companies with broadly applicable technologies," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "ICON's design and manufacturing capabilities have led to highly differentiated stent platforms and bioabsorbable polymer formulations that should enable its deforolimus-eluting stents to provide substantial benefit to patients with coronary and peripheral vascular disease. This agreement further enables ARIAD to focus on developing deforolimus in multiple cancer indications with our partner, Merck & Co., while maximizing the drug's potential non-oncology applications." The proprietary metal alloy (Nuloy(TM)) developed by ICON permits the manufacture of stents with extremely thin struts, yet without sacrificing radial strength. The Nuloy coronary stent system can be readily delivered to target vessels and positioned in difficult-to-reach vascular lesions, without compromising radiopacity (density) or durability of the stent. The Nuloy bare-metal stent has successfully completed its first-in-humans clinical trial. This platform will form the basis for ICON's initial deforolimus-eluting stent for use in coronary arteries. "We are delighted with the opportunity to work together with the ARIAD team. Having access to a well-characterized and broadly studied drug for use in drug-eluting stents should allow ICON to move ahead expeditiously in the development of our portfolio of innovative cardiovascular products for coronary and peripheral vascular disease," said Jay Yadav, M.D., chairman of ICON. President and chief executive officer of ICON, Jack Merritt added, "The combination of the Nuloy stent platform and deforolimus should provide interventional cardiologists with breakthrough treatment options in this growing patient population." About Restenosis and Drug-eluting Stents Restenosis is a reblockage of an artery at the same site where a treatment, such as balloon angioplasty and/or a stenting procedure, has been implemented weeks to months earlier. In patients who have undergone balloon angioplasty and stent placement, restenosis within and around the stent occurs frequently, depending on the stent design and underlying disease. The main reason for such reblockage is the overgrowth of tissue (similar to scar tissue) that may cause narrowing of the vessel and further constriction. Stents that release a drug, such as an mTOR inhibitor (e.g., sirolimus) or a mitotic inhibitor (e.g., paclitaxel), have been shown to reduce the extent of tissue overgrowth, lower the incidence of restenosis and result in improved clinical outcomes for many patients. About Deforolimus ARIAD's lead product candidate, deforolimus, 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. Multiple Phase 1 and 2 clinical trials of deforolimus in solid tumors and hematologic cancers have completed patient enrollment. The ongoing global Phase 3 SUCCEED trial of oral deforolimus in metastatic soft-tissue and bone sarcomas is based on a Special Protocol Assessment agreed upon by the U.S. Food and Drug Administration. ARIAD has a global partnership with Merck & Co., Inc. to develop and commercialize deforolimus in cancer. Blocking mTOR also impedes the wound-healing response to arterial injury that leads to restenosis. ARIAD is collaborating with Medinol Ltd. and ICON Medical Corp. to develop deforolimus-eluting stents to prevent restenosis of injured vessels following interventions in which stents are used in conjunction with balloon angioplasty. About ICON Medical ICON Medical Corp., an emerging cardiovascular medical device company, is engaged in the development of an innovative new stent material, Nuloy(TM), to be used as a platform for both bare-metal and drug-eluting stents. The Nuloy material has inherent properties which allow for extremely thin struts, almost 50% thinner than the most advanced commercial coronary stent available. Nuloy allows ICON to manufacture stents with increased strength, radiopacity and deliverability, and decreased elastic recoil compared with that in existing stent materials. The ICON Nuloy stent material allows for dramatic improvements in crossing profile and deliverability, without compromise to radiopacity and durability of the stent. ICON is also developing a bioabsorbable stent platform based on its Micro-Electro-Mechanical Systems (MEMS) technology for use in peripheral vessels. The MEMS technology allows ICON to enhance mechanical functionality and drug delivery by way of multi-layer tailoring construction of the stent and by incorporating microstructures, which deliver drug directly to the site of injury deep within the medial vessel wall. This controlled delivery of drug followed by stent absorption may result in improved outcomes and re-intervention options in superficial femoral arteries. About ARIAD ARIAD is engaged in the discovery and development of breakthrough medicines to treat cancer by regulating cell signaling with small molecules. ARIAD 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 has a global partnership with Merck & Co., Inc. to develop and commercialize deforolimus, ARIAD's lead cancer product candidate. Medinol Ltd. and ICON Medical Corp. are also developing deforolimus-eluting stents to prevent restenosis of injured vessels following interventions in which stents are used in conjunction with balloon 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 potential payment of clinical, regulatory and commercial milestones and product royalties. 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 strategic partners and licensees, 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 Edward M. Fitzgerald, 617-621-2345 or ICON Jack Merritt, 404-920-2062 or Pure Communications Sondra Newman, 617-877-5687 -----END PRIVACY-ENHANCED MESSAGE-----