Cytogen Announces Settlement Agreement with Advanced Magnetics.PRINCETON, N.J. -- Cytogen Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CYTO CYTO Croydon Youth Theatre Organisation (UK) ) today announced the settlement of its lawsuit against Advanced Magnetics, Inc., as well as Advanced Magnetics' counterclaims against Cytogen, by mutual agreement. Under the terms of the settlement agreement, Advanced Magnetics will pay $4 million to Cytogen and release 50,000 shares of Cytogen common stock currently being held in escrow escrow Instrument, such as a deed, money, or property, that constitutes evidence of obligations between two or more parties and is held by a third party. It is delivered by the third party only upon fulfillment of some condition. . In addition, both parties agreed to early termination of the 10-year license and marketing agreement and supply agreement established in August 2000, as amended, for two imaging agents being developed by Advanced Magnetics, Combidex([R]) (ferumoxtran-10) and ferumoxytol, previously Code 7228. The license and marketing agreement and supply agreement would have expired in August 2010. Under the terms of the original agreement, Cytogen acquired the U.S. commercial rights to Combidex and ferumoxytol for oncology imaging applications only in exchange for 200,000 shares of Cytogen common stock, of which 150,000 were available for resale within four months of the closing and 50,000 were placed in escrow. "After a strategic analysis of (i) the remaining term of the license and marketing agreement, (ii) the delayed approval timeframe, (iii) the ongoing regulatory risks, (iv) the time and expenditures associated with continued litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. , and (v) Cytogen's commercial launch of two oncology therapeutics, the Company concluded it was in the best interest of its stockholders to reach an amicable resolution of this matter at this time," said Michael D. Becker, president and chief executive officer. "This settlement is consistent with our transformation to an oncology therapeutics company and the monetization of assets that are not aligned with our business objectives." In October 2004, Advanced Magnetics submitted a complete response to an approvable letter received from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) dated June 2000 for Combidex. In March 2005, the Oncologic Drugs Advisory Committee voted against recommending approval of Combidex for use in conjunction with magnetic resonance imaging magnetic resonance imaging (MRI), noninvasive diagnostic technique that uses nuclear magnetic resonance to produce cross-sectional images of organs and other internal body structures. (MRI 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. ) to aid in the differentiation of cancerous from normal lymph nodes Lymph nodes Small, bean-shaped masses of tissue scattered along the lymphatic system that act as filters and immune monitors, removing fluids, bacteria, or cancer cells that travel through the lymph system. . Subsequently, Advanced Magnetics received a second approvable letter from FDA with certain conditions. Advanced Magnetics has stated that it hopes to announce its strategy for responding to the March 2005 approvable letter during calendar 2007. About Cytogen Founded in 1980, Cytogen is a biopharmaceutical company dedicated to advancing the care of cancer patients by building, developing, and commercializing a portfolio of specialty pharmaceutical products. The Company's specialized sales force currently markets QUADRAMET([R]), PROSTASCINT([R]), and SOLTAMOX([TM]) to the U.S. oncology market. QUADRAMET is approved for the treatment of pain in patients whose cancer has spread to the bone, PROSTASCINT is a PSMA-targeting monoclonal antibody-based agent to image the extent and spread of prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. , and SOLTAMOX is the first liquid hormonal therapy Hormonal therapy Use of hormone medications to inhibit menstruation and relieve the symptoms of endometriosis. Mentioned in: Endometriosis approved in the U.S. for the treatment of breast cancer in adjuvant adjuvant /ad·ju·vant/ (aj?dbobr-vant) (a-joo´vant) 1. assisting or aiding. 2. a substance that aids another, such as an auxiliary remedy. 3. and metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. settings. In the first half of 2007, Cytogen plans to introduce its fourth approved oncology product to the U.S. market, CAPHOSOL([R]), a prescription medical device for the treatment of oral mucositis and dry mouth. The Company is also developing CYT-500, a third-generation radiolabeled antibody to treat prostate cancer. Cytogen's product-focused strategy focuses on attaining sustainable growth through clinical, commercial, and strategic initiatives. Further information about Cytogen and this press release can be found at http://www.cytogen.com. This press release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 our strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. . 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 successfully marketing its products; 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. All information in this press release, including 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 this information to reflect subsequent events or circumstances. |
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