-----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, M1RZQ9ZlU+X5SWw8mZNwRBf4NyB9ZiqpJvvENyeMZ32Do/7RUqBkptZ8CAHZ1Dgi TTMhub9ruI2rIbDncAxydg== 0000725058-02-000018.txt : 20020917 0000725058-02-000018.hdr.sgml : 20020917 20020917152731 ACCESSION NUMBER: 0000725058-02-000018 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20020916 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20020917 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CYTOGEN CORP CENTRAL INDEX KEY: 0000725058 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] 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: 02765946 BUSINESS ADDRESS: STREET 1: 600 COLLEGE RD EAST CN 5308 CITY: PRINCETON STATE: NJ ZIP: 08540 BUSINESS PHONE: 6099878200 MAIL ADDRESS: STREET 1: 600 COLLEGE RD EAST CN 5308 STREET 2: 600 COLLEGE RD EAST CN 5308 CITY: PRINCETON STATE: NJ ZIP: 08540 8-K 1 hd_form8-k091602.txt CYTOGEN CORP. FORM 8-K 091602 SECURITIES AND EXCHANGE COMMISSION Washington, DC 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 16, 2002 ------------------ CYTOGEN CORPORATION (Exact Name of Registrant as Specified in Charter) Delaware 000-14879 222322400 - -------------------------------------------------------------------------------- (State or Other Jurisdiction (Commission File Number) (IRS Employer of Incorporation) Identification No.) 650 College Road East, CN 5308, Suite 3100, Princeton, NJ 08540 - -------------------------------------------------------------------------------- (Address of Principal Executive Offices) (Zip Code) (609) 750-8200 ------------------------------------------------ (Registrant's telephone number, including area code) 600 College Road East, CN 5308, Princeton, NJ 08540 ------------------------------------------------------------ (Former Name or Former Address, if Changed Since Last Report) Item 5. Other Events. On September 16, 2002, Cytogen Corporation (the "Company") issued a press release reporting the internal restructuring of the Company's AxCell Biosciences subsidiary. On September 17, 2002, the Company issued a joint press release with Matritech Inc. announcing an agreement in principle to enter into a five year agreement for the Company to be the sole United States distributor for Matritech's NMP22(R) BladderChek(TM) test. Such arrangement is pending the approval and execution of a final agreement by both parties. Each such press release is attached hereto as Exhibit 99.1 and Exhibit 99.2, respectively, and each is incorporated herein by reference. The foregoing description of each such press release is qualified in its entirety by reference to each such respective document. Item 7. Financial Statements, Pro Forma Financial Information and Exhibits. (c) Exhibits. Exhibit No. Description ----------- ----------- 99.1 Press release of the Company dated September 16, 2002 99.2 Press release of the Company dated September 17, 2002 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/ Lawrence R. Hoffman ----------------------------------- Lawrence R. Hoffman, Chief Financial Officer Date: September 17, 2002 EX-99 3 f8krelease_091602.txt EXHIBIT 99.1 AXCELL BIOSCIENCES RELEASE Exhibit 99.1 Cytogen Restructures AxCell Biosciences Subsidiary to Support Company Focus on Oncology Product Marketing and Development PRINCETON, N.J., Sept. 16 /PRNewswire-FirstCall/ -- Cytogen Corporation (Nasdaq: CYTO - News), a biopharmaceutical company with an established and growing product line in oncology, today announced a realignment of its AxCell Biosciences subsidiary in an effort to reduce expenses and position Cytogen for stronger long-term growth in oncology. The plan, which includes a 75% reduction in workforce at AxCell Biosciences, will allow continued research related to the role of novel proteins and signal transduction pathways in disease progression through both external collaborations and internal data mining. "This restructuring is a reflection of both the evolving opportunities in functional proteomics research as well as the realities of current market conditions," said Michael D. Becker, interim chief executive officer of AxCell Biosciences. "While AxCell will continue to pursue promising opportunities in the area of signal transduction research, this move reinforces Cytogen's stated corporate objective of developing and marketing oncology products." In accordance with the new plan, AxCell has reduced its staff by approximately 75%, suspended certain projects, and implemented several other cost-saving measures. This action is expected to lower Cytogen's annual operating expenses by approximately $1.4 million beginning in the fourth quarter of 2002. "Cytogen's long-term strategy and business plan remain on track," said H. Joseph Reiser, Ph.D., president and chief executive officer of Cytogen Corporation. "Adjusting AxCell's cost structure will position us to meet our financial objectives and continue to build on the strengths of our core oncology business strategy." Following the restructuring, AxCell will continue to support key research projects that are in the later stages of development as well as those programs that involve the most productive research collaborations. The Company is moving aggressively forward in evaluating and prioritizing the programs that offer the greatest commercial potential and will continue to explore strategic alternatives for AxCell through its investment banker. "As the potential market applications for proteomics research continue to evolve, AxCell offers a very balanced and adaptable business model," concluded Becker. "This restructuring allows us to reduce costs while maintaining many of the organization's core competencies." About Cytogen Corporation Cytogen Corporation of Princeton, NJ is a biopharmaceutical company with an established and growing product line in prostate cancer and other areas of oncology. Currently marketed products include ProstaScint(R) (a monoclonal antibody-based imaging agent used to image the extent and spread of prostate cancer); BrachySeed(TM) I-125 and Pd-103 (two uniquely designed, next- generation radioactive seed implants for the treatment of localized prostate cancer); and Quadramet(R) (a skeletal targeting therapeutic radiopharmaceutical marketed for the relief of bone pain in prostate and other types of cancer). Cytogen is evolving a pipeline of oncology product candidates by developing its prostate specific membrane antigen, or PSMA, technologies, which are exclusively licensed from Memorial Sloan-Kettering Cancer Center. AxCell Biosciences of Newtown, PA, a subsidiary of Cytogen Corporation, is engaged in the research and development of novel biopharmaceutical products using its portfolio of functional proteomics solutions and collection of proprietary signal transduction pathway information. For more information, visit www.cytogen.com and www.axcellbio.com. This press release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. Information in this press release, which is not historical, is forward-looking and involves a number of risks and uncertainties. Investors are cautioned not to put any undue reliance on any forward-looking statement. The Company's actual results may differ materially from the Company's historical results of operations and those discussed in the forward-looking statements for various reasons, including, but not limited to the Company's ability to carry out its business plan, to successfully develop and commercialize acceptance of its products such as ProChart(TM), to determine and implement the appropriate strategic initiative for its AxCell Biosciences subsidiary, ability to fund development necessary for existing products and for the pursuit of new product opportunities, the risk of whether products result from development activities, protection of its intellectual property portfolio, ability to integrate in-licensed products such as BrachySeed(TM), ability to establish and successfully complete clinical trials where required for product approval, the risk associated with obtaining the necessary regulatory approvals, shifts in the regulatory environment affecting sale of the Company's products such as third-party payor reimbursement issues, dependence on its partners for development of certain projects, the ability to obtain foreign regulatory approvals for products and to establish marketing arrangements in countries where approval is obtained, continued listing of the Company's common stock on the Nasdaq National Market, and other factors discussed in Form 10-K for the year ended December 31, 2001 and from time-to-time in the Company's other filings with the Securities and Exchange Commission. The Company specifically disclaims any intention or duty to update any forward-looking statements, and these statements represent the Company's current outlook only as of the date given. EX-99 4 release-091702.txt EXHIBIT 99.2 Exhibit 99.2 Matritech Selects Cytogen to Market and Distribute New Point-of-Care Diagnostic Test for Bladder Cancer in U.S. - -NMP22(R) BladderChek(TM) superior to current urine test, cytology, and returns results during a patient's doctor office visit- Newton, MA & Princeton, NJ (September 17, 2002) - Matritech Inc. (NASDAQ: NMPS) and Cytogen Corporation (NASDAQ: CYTO) today announced that they have reached an agreement in principle to enter into a five year agreement for Cytogen to be the sole United States distributor for Matritech's NMP22(R) BladderChek(TM) test. NMP22 BladderChek was recently approved by the U.S. Food and Drug Administration as a point-of-care test for the management of patients with bladder cancer. Pending approval and execution of a final agreement by both parties, Cytogen and Matritech expect to have the product available to physicians during the next 30 days. "Cytogen Corporation has a strong and established position in the urologic oncology market and the ideal experience to distribute NMP22 BladderChek," said David Corbet, president and chief operating officer of Matritech. "Their in-house sales force has extensive experience selling comparable diagnostic products to urologists in the United States, and we believe they will achieve rapid market penetration for NMP22 BladderChek." NMP22 BladderChek measures the level of NMP22, a specific marker associated with bladder cancer and only the second tumor marker (in addition to prostate specific antigen, or PSA) approved by the U.S. FDA and established in its laboratory format for screening and monitoring cancer patients. The level of NMP22 is often elevated in patients with bladder cancer, even at the earliest stages of the disease. NMP22 BladderChek, which looks and works much like a home pregnancy test, requires only a few drops of the patient's urine and typically provides results in 30 minutes during a single office visit. "The NMP22 BladderChek diagnostic test is a natural extension of our established and growing product line in the diagnosis, staging and treatment of urologic cancers," said H. Joseph Reiser, Ph.D., president and chief executive officer of Cytogen Corporation. "In addition, since the urologist is the point of call, we are able to leverage our existing sales force investment more effectively. We are pleased to be associated with Matritech and NMP22, which helps identify bladder cancer earlier and with greater ease and accuracy." Clinical trial results show that NMP22 BladderChek detected four times more early-stage bladder tumors and 2.5 times as many life threatening, high-grade tumors as cytology, a widely-used bladder cancer urine test. It is expected that NMP22 BladderChek will be used in conjunction with cystoscopy, a clinical procedure that involves the use of a fiber optic tube inserted into the bladder through the urethra to visually identify tumors. "The market opportunity for NMP22 BladderChek has never been greater," said Corbet. "The FDA has cleared the device for use in the United States, and urologists at the most recent American Urological Association meeting expressed tremendous interest in ordering the test. In addition, we have been experiencing increasing sales and reorders in Europe, where our distributors are teaching physicians about NMP22 BladderChek's clinical value. We are excited to work with Cytogen, a focused and dedicated distribution partner for the United States market." Bladder cancer is the sixth most common cancer in the United States. Matritech estimates that the total available U.S. urology market for the NMP22 tests is 2.7 million tests annually, representing an initial screening population of 1.2 million in addition to 1.5 million patients being monitored for recurrence after treatment. The American Cancer Society estimates that in 2002 there will be about 56,500 new cases of bladder cancer diagnosed in the United States (about 41,500 men and 15,000 women), and that 12,600 people (about 8,600 men and 4,000 women) will die from the disease. Matritech's previous distribution agreement with Endocare Inc. of Irvine, Calif. has been terminated by mutual agreement. Matritech signed a distribution agreement in 2001 with TIMM Medical Technologies, which was subsequently acquired in March of this year by Endocare. About Matritech Matritech is a leading developer of proteomics-based diagnostic products for the early detection of cancer. Using its patented proteomics technology, Matritech has identified proteins correlated with breast, bladder, prostate, cervical and colon cancers. Matritech is one of the first companies to successfully employ proteomics to create diagnostic products. The Company holds one of only two FDA tumor marker approvals for the initial detection of cancer. The FDA-approved NMP22 bladder cancer test is currently used by urologists. In addition, the Company has a promising blood-based breast cancer test, NMP66, in clinical trials. Initial research on a prostate cancer marker, NMP48, identified by Matritech scientists shows the marker to be more accurate than the widely used PSA test. NMP technology is licensed exclusively to Matritech from the Massachusetts Institute of Technology. About Cytogen Cytogen Corporation of Princeton, NJ, is a biopharmaceutical company with an established and growing product line in prostate cancer and other areas of oncology. Currently marketed products include ProstaScint(R) (a monoclonal antibody-based imaging agent used to image the extent and spread of prostate cancer); BrachySeedTM I-125 and Pd-103 (two uniquely designed, next- generation radioactive seed implants for the treatment of localized prostate cancer); and Quadramet(R) (a skeletal targeting therapeutic radiopharmaceutical marketed for the relief of bone pain in prostate and other types of cancer). Cytogen is evolving a pipeline of oncology product candidates by developing its prostate specific membrane antigen, or PSMA, technologies, which are exclusively licensed from Memorial Sloan-Kettering Cancer Center. AxCell Biosciences of Newtown, PA, a subsidiary of Cytogen Corporation, is engaged in the research and development of novel biopharmaceutical products using its portfolio of functional proteomics solutions and collection of proprietary signal transduction pathway information. For more information, visit www.cytogen.com and www.axcellbio.com. Statement Under the Private Securities Litigation Reform Act Any forward-looking statements related to Matritech's or Cytogen's expectations regarding their current and future products, regulatory approvals and expected customer sales are subject to a number of risks and uncertainties, many of which are beyond their control. These include but are not limited to, risks related to unforeseen delays in, or denials of regulatory approvals, future product demand and pricing, performance of distributors, competitive products and technical developments, health care reform and general business and economic conditions. There can be no assurance that Matritech's or Cytogen's expectations for their products will be achieved. ### -----END PRIVACY-ENHANCED MESSAGE-----