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FDA Approves BrachySeed Pd-103 (Palladium-103 Implant) for Localized Prostate Cancer Tumours MISSISSAUGA, ON - June 29, 2001 -Draximage Inc. has received U.S. Food and Drug Administration (FDA) approval to market its palladium-103 brachytherapy implant (BrachySeed™ Pd-103) for the treatment of prostate cancer and other selected localized tumours of the head, neck, lung, pancreas, breast, and uterus. Dr. Martin Barkin, President and CEO of Draxis Health, stated, "Earlier this year the Company launched its BrachySeed™ I-125 into both the Canadian and U.S. marketplaces. Today, we are pleased to announce FDA approval of our complementary BrachySeed Pd-103. Both versions of our second generation BrachySeed are based on the same patented design, which leads to improved dosimetry and a more controlled dose rate to the target. Fully robotic manufacturing permits customized manufacturing of BrachySeed to within 3 percent of the desired target activity, an industry leading standard." Dr. Barkin continued, "Palladium-based brachytherapy implants now account for approximately 40 percent 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 Pd-103 will become commercially available later this year when approved by the U.S. Nuclear Regulatory Commission. BrachySeed Pd-103 will be distributed by Cytogen Corporation in the U.S. market. Cytogen already markets BrachySeed I-125 and ProstaScint®, 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 percent over the last three years. SOURCE: Draxis Health Inc. E-mail this page to a friend or colleague! To print, use this version