Due to unexpected difficulties in the manufacture of BIVIGAM® encountered by Biotest Pharmaceuticals Corporation, the agreement for distribution rights of BIVIGAM® in the United States between Biotest and Kedrion Biopharma has been terminated. Biotest, the manufacturer of BIVIGAM®, is unable to sustain a supply of BIVIGAM® given issues affecting the company’s manufacturing operations in Boca Raton. Termination of the contract means that BIVIGAM® will no longer be available for sale or distribution for at least the remainder of 2017. There is currently minimal product in the distribution channel that we expect to last through February of 2017 to fulfill existing patient needs. Patients who currently rely on BIVIGAM® are advised to consult with their healthcare professional or pharmacist to help identify therapeutic alternatives as the supply of BIVIGAM® is exhausted.
In January 2016, Kedrion Biopharma gained exclusive distribution rights to BIVIGAM® in the U.S. with Biotest Pharmaceuticals Corporation. Biotest holds the Biologics License Application for BIVIGAM®.
Kedrion Biopharma, which also distributes a range of other products, remains committed to further developing its IG franchise, including a currently-marketed 10% intravenous immunoglobulin (IGIV) therapy.
For questions related to BIVIGAM®, please call the BIVIGAM® Customer Support Center at 1-800-458-4244.
If you are a healthcare provider or patient interested in learning more about therapeutic alternatives, please visit the Kedrion Biopharma website.