December 1, 1998
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Genzyme General Receives FDA Marketing Approval for Thyrogen
CAMBRIDGE, Mass. -- Genzyme General (Nasdaq:GENZ) announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Thyrogen(R) (thyrotropin alfa for injection) for use in follow-up screening of patients who have been treated for thyroid cancer.
Under the label approved by the FDA, Thyrogen is indicated for use as "an adjunctive diagnostic tool for serum thyroglobulin testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer."
This indication will allow physicians to use Thyrogen with a broad group of thyroid cancer patients. Serum thyroglobulin testing and radioiodine imaging are the two diagnostic procedures most commonly used with patients being examined for remnant thyroid tissue, thyroid cancer recurrence or metastases. In the U.S., physicians order approximately 135,000 thyroglobulin tests and 25,000 radioiodine imaging whole body scans each year for thyroid cancer patients.
Thyrogen has been shown to significantly enhance the sensitivity of thyroglobulin testing in patients maintained on thyroid hormone therapy. Thyrogen also allows thyroid cancer patients to avoid the debilitating effects of hypothyroidism when undergoing radioiodine imaging scans. In a phase III clinical study, the combination of a Thyrogen-stimulated scan and a serum thyroglobulin test, although not as sensitive as combination testing performed after patients were withdrawn from thyroid hormone supplements, did detect all patients with metastatic disease.
"Thyrogen provides physicians with an effective new tool in the management of thyroid cancer, and it allows patients to lead productive lives while undergoing diagnostic testing," said Henri A. Termeer, chairman and chief executive officer of Genzyme Corp. "FDA approval of Thyrogen is a very exciting and important event for Genzyme, and we look forward to introducing this product as quickly as possible."
Patients who have had partial or total removal of their thyroid gland must take thyroid hormone supplements to maintain their metabolism and to suppress endogenous levels of thyroid stimulating hormone (TSH). However, a high level of TSH in a patient's bloodstream is necessary in order for radioiodine imaging to detect remnant thyroid tissue or metastatic disease and to achieve optimal sensitivity of serum thyroglobulin testing. Therefore, patients must stop taking their hormone supplements for two to six weeks prior to testing. This thyroid hormone withdrawal causes patients to experience fatigue, weight gain, constipation, mental dullness, lethargy, depression, and other adverse reactions. Thyrogen, which is a recombinant form of TSH, allows patients to avoid hormone withdrawal and its debilitating effects while undergoing diagnostic testing.
The most common adverse events reported in clinical studies of Thyrogen were nausea and headache. Mild reactions of hypersensitivity consisting of urticaria and rash have also been reported. In clinical studies, no patients have developed antibodies to Thyrogen after either single or repeated use of the product.
Market Introduction
Genzyme will begin marketing Thyrogen immediately in conjunction with Knoll Pharmaceutical Co. of Mount Olive, N.J. Genzyme and Knoll have formed a collaboration under which Knoll's well-established endocrine and metabolic sales force will promote Thyrogen. Genzyme will maintain its own team of clinical specialists to collaborate with Knoll on Thyrogen educational efforts and to facilitate relationships with leading endocrinologists.
Knoll develops, manufactures, and markets a wide range of prescription therapeutics, including SYNTHROID (tm) (levothyroxine sodium tablets, USP), the leading thyroid hormone replacement therapy in the United States. Knoll markets SYNTHROID to endocrinologists, the physicians who primarily treat thyroid diseases and who will prescribe Thyrogen.
Genzyme General develops and markets therapeutic and surgical products and diagnostic products and services. A division of the biotechnology company Genzyme Corp., Genzyme General has its own common stock intended to reflect its value and track its economic performance.
This press release contains a forward-looking statement about the number of thyroglobulin tests and whole body scans performed annually on thyroid cancer patients in the U.S. Actual results may differ materially depending on the accuracy of Genzyme's information about the number of thyroglobulin tests and whole body scans performed annually on thyroid cancer patients in the U.S.
A package insert with complete prescribing information is available on Genzyme's web site and by calling 800-745-4447.
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Genzyme's releases are available at http://www.genzyme.com and on the company's fax-on-demand service at 1-800-436-1443 in the U.S. or 1-201-521-1080 elsewhere.
Genzyme General will host a conference call today at 4:30 p.m. Eastern to discuss the FDA approval of Thyrogen. A replay of the conference call will be available from 6:00 p.m. today through midnight on December 8. To hear the replay, please call 800-633-8284 in the United States or 303-248-1201 outside the United States. Callers should refer to reservation number 1981923.
A package insert with complete prescribing information can also be found here on Newswise as a separate document.
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