Hemophilia Solutions
An Update on Supply
November 2001 • No. 1

During this extreme shortage of factor VIII therapies, Wyeth/Genetics Institute will issue Hemophilia Solutions to update the community about the supply of our hemophilia treatments and our progress towards increasing production capacity. We plan to issue Hemophilia Solutions via facsimile approximately every two months, or more frequently if needed.

Current Distribution of Factor VIII Treatments
ReFacto Antihemophilic Factor (Recombinant) became available in limited supply in the United States in January 2001. Knowing that we would have a limited supply of product, and that there was a tight supply of factor VIII products overall, we allocated our ReFacto distribution among hemophilia treatment centers (HTCs) and home healthcare companies (HHCs). One of the reasons that we chose this distribution method was that it allowed us to provide an uninterrupted supply of ReFacto for patients who started on ReFacto at the beginning of the year.

Practically speaking, this allocation meant that at the beginning of the year, we offered each HTC and HHC a set number of ReFacto units. The number of ReFacto units that we made available to the organizations was proportional to the percentage of U.S. hemophilia patients that they served. We obtained our information on each organization's patient base directly from the federal government and other reliable sources.

The organizations that ordered their allocation in the first quarter were considered to have a future standing order for approximately that amount. Since our supply of ReFacto has remained relatively constant over this year, we have had very little additional ReFacto available for new patients.

While we have been working with the limited amount of ReFacto available to us, we have also been working to expedite the development of new manufacturing facilities so that we can produce more ReFacto.

Additional ReFacto Supply Projected for Second Quarter 2002
As you may know, we acquired ReFacto from Pharmacia & Upjohn in 1997, after the company had decided to discontinue the commercial development of ReFacto. As part of our arrangement with Pharmacia & Upjohn, ReFacto is produced in its Stockholm, Sweden facility. Knowing that our production capacity would be limited by Pharmacia & Upjohn's facilities, we began making plans to create our own manufacturing facilities for ReFacto when we purchased the product.

This process began nearly four years ago by expanding our current facilities and creating new ones as part of our long-term plan to provide hemophilia therapies to the community worldwide. We are in the final stages of completing this effort, which represents a significant investment for our company for hemophilia A therapies. Now, in addition to a manufacturing facility in Stockholm, Sweden, we are building a new facility in St. Louis, Mo.

Our first opportunity to make an impact on the global factor VIII shortage, and specifically in the United States, will occur when we begin shipping product made at our new facility, which is now projected for second quarter of 2002. We are finishing the work on these new facilities, and are coordinating with the regulatory authorities to obtain the necessary approvals. We understand the absolute urgency of our efforts, and we are moving as quickly as possible through these final stages. Once we have received the necessary regulatory approval, we anticipate that we can produce additional ReFacto soon after. As a result of our production expansion, we estimate that we will be able to significantly increase our current output of ReFacto.

BeneFIX Supply Meets World Demand
Since the launch of BeneFIX Coagulation Factor IX (Recombinant) in 1997, Wyeth/Genetics Institute has been able to provide the world supply of this recombinant factor IX treatment. As part of our long-term plan to continue to meet the growing world demand, we have expanded our manufacturing capacity for BeneFIX in Andover, and are adding a new production facility in Upper Merion, Pa., which should be operational in 2003, pending regulatory approvals.

Important Product Information
BeneFIX is indicated for the control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease), including control and prevention of bleeding in surgical settings.

As with the intravenous administration of any protein product, common adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, or lethargy. Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX products. Patients should be informed of the early symptoms and signs of hypersensitivity reactions. Patients should discontinue use of the product and contact their health care provider immediately and/or seek emergency care if any hypersensitivity reactions occur.

ReFacto is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia). ReFacto is indicated for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes. The effect of regular routine prophylaxis on long-term morbidity and mortality is unknown.

With the intravenous administration of any protein product, adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, lethargy, or manifestations of allergic reactions. The remote possibility exists for hypersensitivity to non-human mammalian proteins.

Commitment to the Hemophilia Community
We will continue to update you on our progress as we move forward with our plans to increase ReFacto production. Today, as always, our goal is to create effective recombinant factor products with enhanced viral safety for the hemophilia community.

If you would like to correct your fax number in our database or remove yourself from our list, please contact us at 484-865-3256.

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