DRAXIS Receives FDA Approval For BrachySeed -TM- Pd-103.Business Editors MISSISSAUGA, Ontario--(BUSINESS WIRE)--June 28, 2001 DRAXIS Health Inc. (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.) today announced that its radiopharmaceutical radiopharmaceutical /ra·dio·phar·ma·ceu·ti·cal/ (-fahr?mah-soo´ti-k'l) a radioactive pharmaceutical, nuclide, or other chemical used for diagnostic or therapeutic purposes. subsidiary, DRAXIMAGE Inc., has received 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. ) approval to market its palladium-103 brachytherapy implant (BrachySeed(TM) Pd-103) for the treatment of prostate cancer and other selected localized tumours such as tumours of the head, neck, lung, pancreas, breast, and uterus. 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 FDA approval of our complementary BrachySeed(TM) Pd-103. Both versions of our second generation BrachySeed(TM) are based on the same 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 permits customized manufacturing of BrachySeed(TM) to within 3% of the desired target activity, an industry leading standard." Dr. Barkin continued, "Palladium-based brachytherapy implants now account for approximately 40% of the U.S market and 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. Growth and acceptance of palladium brachytherapy is expected to increase market share as more and more physicians choose palladium over iodine. DRAXIS will be one of the few companies to offer both iodine-125 and palladium-103 implants." Dr. Barkin concluded, "We anticipate that BrachySeed(TM) Pd-103 will become commercially available later this year when approved by the U.S. 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. . BrachySeed(TM) Pd-103 will be distributed by Cytogen Corporation (NASDAQ: CYTO CYTO Croydon Youth Theatre Organisation (UK) ) in the U.S. market. Cytogen already markets BrachySeed(TM) I-125 and ProstaScint(R), the leading imaging agent used to monitor, detect and guide prostate cancer therapy." 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 brachytherapy implant. DRAXIMAGE has a number of products in late-stage development 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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