DRAXIS Receives FDA Approval For BrachySeed.Business Editors MISSISSAUGA, Ontario--(BUSINESS WIRE)--Aug. 24, 2000 DRAXIS Health Inc. (TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :DAX.)(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) 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 Iodine-125 BrachySeed(TM) for the treatment 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. . Prostate cancer is a serious medical condition with over 180,000 new cases diagnosed in the United States in 1999, as reported by the American Cancer Society American Cancer Society, n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research, . Approximately 40,000 men die annually from this disease 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, "We are very pleased to report that our patented BrachySeed(TM) product has been approved by the FDA. This follows Canadian regulatory approvals which were received earlier in the year. It is our expectation that this product will be ready to be marketed in both the U.S. and Canada late this year. We still require approval 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. and the Canadian Atomic Energy Control Board but expect these approvals to be forthcoming." Dr. Barkin continued, "The market size for brachytherapy seeds in the U.S. is approaching $200 million annually and continues to grow. BrachySeed(TM) offers certain advantages over existing products. The most important advantage was reported earlier by researchers at McMaster University, who confirmed that the dose and radiation distribution of BrachySeed(TM) exhibits excellent symmetry. Uniformity and symmetry are very important characteristics which ultimately serve to reduce or eliminate altogether the occurrence of "cold spots", areas within the target organ target organ n. A tissue or organ that is affected by a specific hormone. target organ, n the organ or body part whose activity levels demonstrate change in the course of biofeedback. not reached by the radiation, that may occur when seeds do not provide symmetrical and spherical fields of radiation." Dr. Barkin concluded, "We are also pleased to report that the FDA has approved BrachySeed(TM) for the treatment of certain other localized cancers, such as tumors of the head, neck, lung, pancreas, breast and uterus. While brachytherapy implants have gained recognition and acceptance in the treatment of prostate cancer, it is important to note that these implants have many other potential applications as well." Brachytherapy implants are used in the treatment of localized cancers, primarily prostate cancer, the second most common form of cancer and the second leading cause of cancer deaths in men. While brachytherapy has been available since the 1970's, it has only started to gain prominence and greater acceptance within recent years, coinciding with the development of advanced technologies to aid seed placement. Brachytherapy is the fastest growing treatment for early stage prostate cancer and offers a number of advantages compared to alternative treatments, including: rapid patient recovery, lower costs and reduced incidence of complications such as impotency and incontinence. BrachySeed(TM) is a second-generation brachytherapy implant which demonstrates a number of important innovations over currently available technology; it is doubly encapsulated for additional patient safety and it exhibits a near spherical 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. . DRAXIMAGE has developed and built a fully robotic assembly line for BrachySeed(TM) which will enable the company to supply the rapidly growing North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. demand for brachytherapy implants. DRAXIMAGE, based in Kirkland, Quebec, is Canada's leading manufacturer of radiopharmaceuticals and its products are available in many countries around the world. DRAXIMAGE specializes in the discovery, development, manufacturing and marketing of diagnostic and therapeutic products for use in Nuclear Medicine and Oncology. Fibrimage(R), the Company's diagnostic agent for 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. is undergoing Phase III clinical trials in Canada. DRAXIS Health Inc. is a diversified speciality pharmaceutical company operating in three niche markets: Radiopharmaceuticals (DRAXIMAGE), Canadian sales and marketing (DRAXIS Pharmaceutica) and Companion Animal Health (through its global alliance with Pfizer Inc.). DRAXIS supports its own as well as third party manufacturing requirements through its subsidiary, DRAXIS Pharma, located in Kirkland, Quebec. 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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