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T99-15                     Print Media:         301-827-6242
April 1, 1999                     
                           Consumer Inquiries:  888-INFO-FDA

FIRST BIOLOGIC APPROVED FOR CLOTTING DISORDER

FDA today approved a new indication for a plasma-derived product called Antihemophilic Factor/von Willebrand Factor Complex (Human), marketed as Humate-P. The product is now approved to treat severe or hard-to-treat cases of von Willebrand's disease (vWD), a bleeding disorder. It was previously approved for adult patients with hemophilia A.

The disease vWD is the most common hereditary bleeding disorder, affecting approximately 1% of the U.S. population. It is caused by a deficiency or defect in certain plasma proteins critical to blood clotting. In most people the disease is mild and treatment is usually not required to control bleeding. However, approximately 2,000 people in the U.S. each year suffer from severe forms of the disease where bleeding can be excessive if not treated.

A drug, desmopressin, is an effective treatment for some forms of vWD, but for about 600 patients, plasma-derived products are needed. Humate-P is the only approved plasma-derived treatment for vWD.

Humate-P is purified from pooled human plasma from many donors and contains the clotting proteins deficient or defective in vWD disease, factor VIII and von Willebrand factor. It is pasteurized by heat treatment, a highly effective FDA approved process for deactivating many viruses that cause disease, including AIDS and certain types of hepatitis. In addition plasma donors are screened carefully. However, because the product is made from human plasma, the risk for the transmission of blood-borne viruses, while very low, cannot be totally eliminated.

In a clinical study with vWD patients, approximately 95% of both pediatric and adult patients reported an excellent or good response to Humate-P in regard to the control of bleeding episodes.

Currently not enough evidence exists from clinical trials to evaluate the efficacy of Humate-P in preventing spontaneous or excessive bleeding related to surgery in vWD patients.

Humate-P will be marketed by Centeon L.L.C., Kankakee, Illinois.

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