Thyroid diagnostic enters U.S. market

Draximage of Mississauga, ON, has won FDA approval to market sodium iodide I-131 to evaluate metastases associated with thyroid cancer. The company already markets stronger therapeutic doses of the radioactive agent.

The lower strength I-131 capsules, which were approved by the FDA in early January, are designed to gauge the uptake of radioactive iodide as an indicator of thyroid function prior to treatment. In this way, physicians can calculate the therapeutic dose of iodine, according to the company.

The move into diagnostics is the latest in a strategic redirection by Draximage, which last year discontinued the manufacture and sale of implantable brachytherapy seeds. The Canadian firm has since focused its portfolio on sodium iodide I-131 capsules and oral solution for the diagnosis and treatment of thyroid cancer and hyperthyroidism.

A primary offering is its HiCon kit, a large-format kit for the preparation of therapeutic sodium iodide I-131. The kit, introduced in 2003, provides radiopharmacists with empty gelatin capsules and filler material needed to construct a therapeutic dose of radioactive iodine.

"The radiopharmacist has the ability to custom titrate these capsules for each individual patient," said Jerry Ormiston, executive director of investor relations at Draximage.

Draximage sales account for 40% to 50% of the U.S. market for radioactive iodine, which is prescribed for patients with thyroid cancer and parathyroidism. The diagnostic capsules and HiCon kits provide ancillary means to further penetrate that market.

The company also markets a line of lyophilized technetium-99m kits. These are nonradioactive kits used in the preparation of diagnostic doses of technetium.

The company exited the brachytherapy marketplace late last year because the radioactive iodine seeds the company sold for use in therapy against prostate cancer had been commoditized, according to Ormiston.

"Brachytherapy is growing in terms of the number of treated patients, but pricing has been driven down by competition," he said. "You need a much larger volume to be profitable."

To minimize the chance of supply disruptions for its customers, Draximage established a customer supply alternative with Oncura, one of the leading suppliers of prostate brachytherapy products.