-----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, Cn01LOwb0qn+o+QOJXQSPHjnZSbry11MmJIR/wBw+g0dS0HDTPkfqpNval2o5Sst VUZzSig4sGgpbPIEzLKPrw== 0000725058-05-000015.txt : 20050303 0000725058-05-000015.hdr.sgml : 20050303 20050303155706 ACCESSION NUMBER: 0000725058-05-000015 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050303 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050303 DATE AS OF CHANGE: 20050303 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CYTOGEN CORP CENTRAL INDEX KEY: 0000725058 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 222322400 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-14879 FILM NUMBER: 05657983 BUSINESS ADDRESS: STREET 1: 650 COLLEGE RD EAST STE 3100 CITY: PRINCETON STATE: NJ ZIP: 08540 BUSINESS PHONE: 6099878200 MAIL ADDRESS: STREET 1: 650 COLLEGE RD EAST STE 3100 CITY: PRINCETON STATE: NJ ZIP: 08540 8-K 1 form8-k_030305.txt FORM 8-K FILED ON 03/03/05 COMBIDEX 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): March 3, 2005 ------------- CYTOGEN CORPORATION -------------------------------------------------------- (Exact Name of Registrant as Specified in Charter) Delaware 000-14879 22-2322400 - ---------------------------- ------------------------ ------------------- (State or Other Jurisdiction (Commission File Number) (I.R.S. Employer of Incorporation) Identification No.) 650 College Road East, CN 5308, Suite 3100, Princeton, NJ 08540 - --------------------------------------------------------------- ------------- (Address of Principal Executive Offices) (Zip Code) Registrant's telephone number, including area code: (609) 750-8200 -------------- - -------------------------------------------------------------------------------- (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. On March 3, 2005, Advanced Magnetics, Inc. and Cytogen Corporation announced that the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) voted 15 to 4 to not recommend approval of the proposed indication for Combidex(R), Advanced Magnetics' investigational functional molecular imaging agent. In making its recommendation, the committee cited insufficient clinical data to support a broad indication for use of Combidex to differentiate metastatic from non-metastatic lymph nodes across all cancer types. Combidex (ferumoxtran-10) consists of iron oxide nanoparticles for use in conjunction with magnetic resonance imaging (MRI) to aid in the differentiation of cancerous from non-cancerous lymph nodes. Combidex received an approvable letter, subject to certain conditions, from the FDA in June 2000. In September 2004, Advanced Magnetics submitted a complete response to the approvable letter. A decision by the FDA on Combidex is expected by the FDA-designated user fee goal date of March 30, 2005. The full text of the March 3, 2005 press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K, and is incorporated herein by reference. The foregoing description is qualified in its entirety by reference to such Exhibit. ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS (c) Exhibits. Exhibit No. Description ----------- ----------- 99.1 Press Release of Advanced Magnetics and Cytogen dated March 3, 2005 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. CYTOGEN CORPORATION By: /s/ William J. Thomas ----------------------------------------- William J. Thomas Senior Vice President and General Counsel Dated: March 3, 2005 EXHIBIT INDEX Exhibit No. Description ----------- ----------- 99.1 Press Release of Advanced Magnetics and Cytogen dated March 3, 2005 EX-99 2 press_release-030305.txt EXHIBIT 99.1 PRESS RELEASE Company contacts: Advanced Magnetics, Inc. Cytogen Corporation Lisa Gordon, VP of Business Development FOR MEDIA: FOR INVESTORS: 617- 497-2070 x 3024 Bill Daddi Brian Korb Lynn Kettleson Belsito & Company The Trout Group 617-512-5922 917-620-3717 917-653-5122 FOR IMMEDIATE RELEASE - --------------------- ONCOLOGIC DRUGS ADVISORY COMMITTEE RECOMMENDS AGAINST APPROVAL OF A BROAD INDICATION FOR COMBIDEX(R) CAMBRIDGE, MA AND PRINCETON, NJ - March 3, 2005 - Advanced Magnetics, Inc. (Amex: AVM) and Cytogen Corporation (Nasdaq: CYTO) announced today that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 15 to 4 to not recommend approval of the proposed indication for Combidex(R), Advanced Magnetics' investigational functional molecular imaging agent. In making its recommendation, the committee cited insufficient clinical data to support a broad indication for use of Combidex to differentiate metastatic from non-metastatic lymph nodes across all cancer types. A decision by the FDA on Combidex is expected by the FDA-designated user fee goal date of March 30, 2005. "We understand the advisory committee's position relative to a broad label for Combidex and look forward to meeting with the FDA to determine appropriate next steps. We remain committed to the ongoing development of Combidex," said Jerome Goldstein, Chairman, President and Chief Executive Officer of Advanced Magnetics. ABOUT THE ODAC The ODAC is a committee formed by the FDA of external experts to provide the FDA with independent opinions and recommendations in the evaluation of marketed and investigational drugs for use in the treatment of cancer. The ODAC is comprised of a core of voting members from the fields of general oncology, pediatric oncology, hematologic oncology, immunologic oncology, biostatistics and other related professions, as well as a consumer and patient representatives. -more- ABOUT ADVANCED MAGNETICS Advanced Magnetics, Inc. is a developer of superparamagnetic iron oxide nanoparticles used in pharmaceutical products. As a leader in its field, Advanced Magnetics is dedicated to the development and commercialization of its proprietary nanoparticle technology for use in therapeutic iron compounds to treat anemia, as well as novel imaging agents to aid in the diagnosis of cardiovascular disease and cancer. For more information about Advanced Magnetics, please visit the company's website at http://www.advancedmagnetics.com, the content of which is not part of this press release. ABOUT CYTOGEN CORPORATION Founded in 1980, Cytogen Corporation of Princeton, NJ is a product-driven biopharmaceutical company that develops and commercializes innovative molecules that can be used to build leading franchises across multiple markets. Cytogen's marketed products include QUADRAMET(R)(samarium Sm-153 lexidronam injection) and PROSTASCINT(R)(capromab pendetide) kit for the preparation of Indium In-111 capromab pendetide in the United States. Cytogen also has exclusive United States marketing rights to COMBIDEX(R) (ferumoxtran-10) for all applications, and the exclusive right to market and sell ferumoxytol (previously Code 7228) for oncology applications in the United States. COMBIDEX, an investigational functional molecular imaging agent consisting of iron oxide nanoparticles, is currently being developed for use in conjunction with magnetic resonance imaging to aid in the differentiation of cancerous and non-cancerous lymph nodes, and is under review by the U.S. Food and Drug Administration. Cytogen's development pipeline consists of therapeutics targeting prostate-specific membrane antigen (PSMA), a protein highly expressed on the surface of prostate cancer cells and the neovasculature of solid tumors. Full prescribing information for the Company's products is available at http://www.cytogen.com or by calling 1-800-833-3533. For more information, please visit the Company's website at http://www.cytogen.com, which is not part of this press release. FOR ADVANCED MAGNETICS This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and federal securities laws. Any statements contained in this press release that do not describe historical facts are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include Advanced Magnetics' inability to obtain regulatory approval for Combidex in general and, in particular, the following risks: (1) the possibility that even though Advanced Magnetics' response regarding Combidex was deemed complete by the FDA, the FDA could respond to this submission by issuing an additional approvable letter with additional conditions for approval or the FDA could issue a not approvable letter; (2) the ability to resolve final labeling for Combidex with the FDA; (3) the possibility that even though the FDA has assigned a user fee goal date of March 30, 2005, the FDA may not act by such date; (4) uncertainties regarding market acceptance of Combidex; (5) uncertainties relating to third-party reimbursements to Advanced Magnetics or its partners for Combidex when patients are prescribed Combidex; (6) uncertainties relating to Advanced Magnetics' ability to continue to operate at commercial scale in compliance with FDA regulations and other applicable manufacturing requirements when producing Combidex; (7) uncertainties relating to patents and proprietary rights and (8) other risks identified in Advanced Magnetics' Securities and Exchange Commission filings. Advanced Magnetics cautions readers not to place undue reliance on any forward-looking statements which speak only as of the date they are made. Advanced Magnetics disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. FOR CYTOGEN This press release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, included in this press release regarding Cytogen's strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and investors are cautioned not to put any undue reliance on any forward-looking statement. There are a number of important factors that could cause Cytogen's results to differ materially from those indicated by such forward-looking statements. In particular, Cytogen's business is subject to a number of significant risks, which include, but are not limited to: the risk of obtaining the necessary regulatory approvals; the risk of whether products result from development activities; the risk of shifts in the regulatory environment affecting sales of Cytogen's products such as third-party payor reimbursement issues; the risk associated with Cytogen's dependence on its partners for development of certain projects, as well as other factors expressed from time to time in Cytogen's periodic filings with the Securities and Exchange Commission (the "SEC"). As a result, this press release should be read in conjunction with Cytogen's periodic filings with the SEC. The forward-looking statements contained herein are made only as of the date of this press release, and Cytogen undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. # # # -----END PRIVACY-ENHANCED MESSAGE-----