ReFacto Manufacturing Consolidated to Stockholm, Regulatory Applications for
Investigational Drug Delayed While New Manufacturing Information Filed

January 2004

Wyeth recently announced that it is closing its St. Louis, Missouri, manufacturing facility and consolidating ReFacto^® Antihemophilic Factor (Recombinant) drug substance production to the Stockholm, Sweden, manufacturing facility. Manufacture of the company's investigational plasma-free, albumin-free, antibody-free recombinant factor VIII drug also is transitioning to this facility in Sweden.

The consolidation of the manufacturing of ReFacto at the Stockholm facility is part of an ongoing effort by Wyeth to optimize the manufacture of its biopharmaceutical products. Current and expected increased demand for ReFacto can be met satisfactorily with this new arrangement; the current supply for ReFacto will be unaffected.

As a result of closure of the St. Louis facility and the transfer of drug substance production of the company's investigational recombinant factor VIII drug to the Stockholm facility, the company has withdrawn the current BLA filed with the FDA.

Wyeth fully intends to update the BLA to reflect the change in manufacturing facilities and resubmit it to the FDA after the manufacturing transfer to Stockholm is completed and documents for the Stockholm facility are available for submission to the FDA.

Similarly, in Europe, the company plans to update its marketing application prior to submitting the application to regulatory authorities to reflect the change in manufacturing site. Clinical trials for our investigational drug remain ongoing. Patients and clinicians involved in these clinical trials can be assured that sufficient clinical supply is available to complete the current studies.

Wyeth remains committed to the development of this investigational drug, to providing safe and effective recombinant factor products with enhanced viral safety, and to supporting individualized tailored care for the hemophilia community.

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