October, 2001

Press Release / Source: PRNewswire

Genzyme General, a division of Genzyme Corp., announced today that it will begin marketing Thyrogen(R) (thyrotropin alfa for injection) in Europe this month. Thyrogen is a recombinant human thyroid stimulating hormone indicated for use in the management of patients being followed up for the recurrence of well- differentiated thyroid cancer.

On September 19, the Committee for Proprietary Medicinal Products of the European Medicines Evaluation Agency adopted a positive opinion on a variation to the manufacturing process for Thyrogen, which was necessary for commercial introduction of the product. Thyrogen was approved for marketing in Europe last year and has been available on a named-patient basis since then.

"This action will enable us to make Thyrogen available much more broadly in Europe," said David Meeker, M.D., senior vice president of therapeutics at Genzyme Corp. "Thyrogen fills a serious clinical need, and we look forward to communicating with physicians about the product's role in the management of their patients with thyroid cancer."

Genzyme plans to launch Thyrogen on a country-by-country basis, as pricing and reimbursement approvals are obtained. The product will be sold by Genzyme's existing specialty therapeutics sales force in Europe and through marketing partners in selected countries.

Background Information on Thyrogen

Thyrogen was first approved for marketing in the United States in December 1998 as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging. Thyrogen was developed for use in patients with well-differentiated thyroid cancer who have had their thyroid gland removed. These patients must take thyroid hormone supplements and undergo periodic testing for recurrent or metastatic cancer.

Until the introduction of Thyrogen, patients were required to stop taking their hormone supplements for two to six weeks prior to testing. This thyroid hormone withdrawal raised the level of thyroid stimulating hormone (TSH) in the patient's bloodstream so that residual or recurrent thyroid cancer or metastases could be detected with either or both serum Tg testing and radioiodine imaging, two commonly used methods of screening for thyroid cancer.

Hormone withdrawal, however, also causes fatigue, weight gain, constipation, mental dullness, lethargy, depression, and other adverse reactions. Thyrogen is an external recombinant source of human TSH that can be used with both of these screening methods, allowing patients to remain on their thyroid hormone supplements.

A meaningful risk of missing a diagnosis or underestimating extent of disease remains with Thyrogen-stimulated Tg testing and radioiodine imaging. Therefore, thyroid hormone withdrawal Tg testing with scanning remains the standard diagnostic modality. The most commonly observed adverse events associated with Thyrogen (>5%) are headache and nausea. Please see the full product information available at http://www.thyrogen.com. Further information regarding the use of Thyrogen is available at 1-800-745-4447.

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SOURCE Genzyme General