DRAXIS Files 510-K For BrachySeed -TM- Pd-103.Business Editors MISSISSAUGA, Ontario--(BUSINESS WIRE)--April 26, 2001 DRAXIS (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 :DRAX)(TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :DAX.) DRAXIS Health Inc. (NASDAQ:DRAX)(TSE:DAX.) today announced that its radiopharmaceutical subsidiary, DRAXIMAGE Inc., has filed with 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. ) and the Nuclear Regulatory Commission Nuclear Regulatory Commission (NRC), an independent U.S. government commission, created by the Energy Reorganization Act of 1974 and charged with licensing and regulating civilian use of nuclear energy to protect the public and the environment. (NRC) for the approval of its new Palladium-103 brachytherapy implant for the treatment of prostate cancer. Filings with Canadian regulatory authorities will follow shortly. Dr. Martin Barkin, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of DRAXIS Health, stated, "Earlier this year the Company launched its BrachySeed(TM) I-125 into both the Canadian and U.S. marketplaces. Today, we are pleased to announce that development of our complementary Palladium-103 BrachySeed(TM) is now completed and regulatory filings have been made. Our second generation BrachySeed(TM) Pd-103 incorporates the patented design which leads to improved dosimetry dosimetry /do·sim·e·try/ (do-sim´e-tre) scientific determination of amount, rate, and distribution of radiation emitted from a source of ionizing radiation, in biological d. and a more controlled dose rate to the target. Fully robotic manufacturing allows our implants to be within 3% of the target activity requested by customers - an industry leading standard. We anticipate that this product will become commercially available later this year and will be distributed by Cytogen Corporation (NASDAQ:CYTO CYTO Croydon Youth Theatre Organisation (UK) ) in the U.S. market. Dr. Barkin continued, "Palladium-based brachytherapy implants currently account for approximately one-third of the U.S market. Palladium-103 seeds are predominantly used with more aggressive tumours due to the fact that Palladium-103 decays at three times the rate of Iodine-125, thereby offering a higher initial dose rate to the tumour. DRAXIS will be one of the few companies in the world to offer both an Iodine-125 and Palladium-103 implant." Brachytherapy is the fastest growing treatment for early stage prostate cancer and offers a number of potential benefits compared to alternative treatments such as radical prostatectomy, including: rapid patient recovery, lower costs and reduced incidence of complications such as impotency and incontinence. Given this improved side-effect profile, the market for brachytherapy seeds has grown by 95% over the last three years. DRAXIMAGE discovers, develops, manufactures and markets diagnostic imaging and therapeutic radiopharmaceuticals for the global marketplace. Products currently marketed by DRAXIMAGE include a line of lyophilized ly·oph·i·lize tr.v. ly·oph·i·lized, ly·oph·i·liz·ing, ly·oph·i·liz·es To freeze-dry (blood plasma or other biological substances). [lyophil(ic) + -ize. Technetium-99m kits used in nuclear imaging procedures, a line of imaging and therapeutic products labelled with a variety of isotopes including radioiodine radioiodine /ra·dio·io·dine/ (-i´o-din) any radioactive isotope of iodine, particularly 123I, 125I, and 131I; used in diagnosis and treatment of thyroid disease and in scintiscanning. , and BrachySeed(TM), a second generation Iodine-125 brachytherapy implant. DRAXIMAGE has a number of products in late-stage development including a Palladium-103 BrachySeed(TM) and three Technetium-99m-based diagnostic imaging products: Fibrimage(R) for imaging deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen. currently in Phase III, Amiscan(TM) for the early diagnosis of acute myocardial infarct currently in Phase II, and INFECTON for imaging infection. DRAXIS Health Inc. is a diversified specialty pharmaceutical company with operations in three niche markets: radiopharmaceuticals (DRAXIMAGE), contract manufacturing (DRAXIS Pharma), and pharmaceutical sales and marketing (DRAXIS Pharmaceutica). Except for historical information, this news release contains certain forward-looking statements that involve risk and uncertainties, which may cause actual results to differ materially from the statements made. Such factors include, but are not limited to, changing market conditions, clinical trial results, the establishment of new corporate alliances, the impact of competitive products and pricing, the timely development, regulatory approval and market acceptance of the Company's products, and other risks detailed from time-to-time in the Company's filings with the US Securities and Exchange Commission and Canadian securities authorities |
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