Draxis Health ends sale of brachytherapy seeds, receives FDA approval for new radioactive iodine product

By E. Janene Geiss

Philadelphia, Nov. 22 - Draximage, the radiopharmaceutical division of Draxis Health Inc., said it received approval from the U.S. Food and Drug Administration for a new, larger format of its successful HiCon kit for the preparation of sodium iodide I-131 Capsules and Oral Solution.

With the approval, the company said it initiated its new strategy to focus its product offerings, which includes discontinuing the manufacture and sale of implantable brachytherapy seeds by Dec. 15 as part of an orderly exit from the brachytherapy market, according to a company news release.

Resources once used to develop brachytherapy seeds will be used to bolster the production and marketing of other radiopharmaceuticals, particularly the line of radioactive iodine products, officials said.

To minimize any inconvenience to customers, the company has established a customer supply alternative with Oncura, Inc., the global leader in prostate brachytherapy. Current Draximage brachytherapy customers will have the option to have their accounts transferred to Oncura, officials said.

The newly approved HiCon format was developed at the request of key, high-volume radiopharmacy customers in the United States and better suits the needs of these major radiopharmacies for a convenient and cost effective I-131 kit product, officials said.

This product will serve to round out the existing line of Draximage radioactive iodine I-131 products, which are used for the diagnosis and treatment of thyroid cancer and hyperthyroidism, officials said.

"This FDA approval will allow us to expand our franchise for radioiodine products into high-volume U.S. based radiopharmacies when we introduce the new format in early 2006," Draximage president Jean-Pierre Robert said in the release.

"While the brachytherapy market remains robust, it is challenging for smaller participants such as Draximage. We believe that the long term impact of this product realignment will prove to be positive, given our plans for increased market penetration of our radiopharmaceutical products," Robert added.

Mississauga, Ontario-based Draximage develops, manufactures and markets diagnostic and therapeutic radiopharmaceuticals.

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