Hemophilia Solutions
An Update on Supply
January 2002 • No. 2

We are delighted to announce that Wyeth/Genetics Institute is one step closer to being able to produce additional supply of ReFacto Antihemophilic Factor (Recombinant).

On January 22, 2002, the scientific advisory committee to the European Commission's regulatory agency issued a positive recommendation to approve Wyeth/Genetics Institute's manufacturing facilities in St. Louis, Mo., and in Algete, Madrid, Spain. The advisory committee's recommendation is considered by the European Commission, whose final decision on approval of the facilities may be made anytime within the three months after the decision of the advisory committee.

What does this mean for the U.S. hemophilia community?
After receiving approval by the European regulatory authority for these facilities, our overall production of ReFacto will have the potential to increase approximately three-fold. With this increased supply, we will be able to distribute product now manufactured at our other facility in Europe to other countries, including the United States.

In the United States, we are continuing to work with the Food and Drug Administration (FDA) to gain its approval to manufacture ReFacto at our St. Louis plant for use in the United States. Once we receive this additional regulatory approval for St. Louis, our supply will be increased further. We hope to hear from the FDA in the first half of this year.

We will continue to provide you with updates, through Hemophilia Solutions, about our progress in increasing the supply of our recombinant Factor VIII treatment. Today, as always, our goal is to provide adequate supplies of effective recombinant factor products with enhanced viral safety for the hemophilia community.

For more information on the current U.S. supply of ReFacto and how the product is distributed, please contact us at 484-865-3256 to request a copy of the first issue of Hemophilia Solutions from November 2001. If you wish to correct your fax number in our database or remove yourself from our list, please contact us at the same number.

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