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Draxis Receives FDA Approval for Diagnostic Iodine I-131 Capsules

Product will supplement existing line of products for treating thyroid cancer

MISSISSAUGA, CANADA -- January 13, 2006 -- The radiopharmaceutical business unit of Draxis Health Inc. has received approval from the U.S. Food and Drug Administration (FDA) regarding its supplemental new drug application for Sodium Iodide I-131 Capsules USP, Diagnostic - Oral.

These diagnostic sodium iodide I-131 capsules are intended to be used by physicians to perform the radioactive iodide (RAI) uptake test to evaluate thyroid function prior to treatment with stronger therapeutic doses of sodium iodide I-131. Diagnostic doses of sodium iodide I-131 may also be employed in localizing metastases associated with thyroid malignancies.

The diagnostic capsules, which are supplied in a gelatin capsule for oral administration, will be produced by Draximage, a division of Draxis Specialty Pharmaceuticals Inc., the Montreal-based subsidiary that serves as the operating arm of Draxis Health Inc.

Draximage plans to introduce the new diagnostic capsules into the U.S. market during the first half of 2006, targeting qualified, approved nuclear physicians and/or radiopharmacists. The Draximage sodium iodide I-131 diagnostic capsules will be supplied in several different strengths of radioactivity and Draximage will employ a system of color-coding to allow each patient to be administered the precise dose of radioactive iodine prescribed by their physician.

The Sodium Iodide I-131 Capsules USP, Diagnostic - Oral are a further addition to the existing line of I-131 radiopharmaceutical products produced by Draximage, including its widely used kit for the preparation of Sodium Iodide I-131 Capsules and Oral Solution for the treatment of thyroid cancer and hyperthyroidism. The FDA-approved kit product for therapeutic use was introduced to the U.S. market in 2003.

Thyroid Cancer
The thyroid gland is at the base of the throat and makes important hormones that help the body function normally. According to the website of the American Cancer Society (http://www.cancer.org) thyroid cancer is one of the most common endocrine cancers and is one of the few cancers for which incidence rates in the U.S. have increased over the past several years at a rate of approximately 2 percent per 100,000 people per year. They further estimate that in the year 2005 about 25,690 new cases of thyroid cancer will be diagnosed in the United States.

The website states that thyroid cancer would seem to be much more common in women (approximately 75% of new cases) than in men and it mainly affects younger people, between the ages of 20 and 56. According to the same source, thyroid cancer is one of the least deadly cancers with a 5-year survival rate of nearly 97% for all cases.


SOURCE: Draxis Health Inc.

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