Kedrion Biopharma Inc. announced that it has established the framework for a long-term agreement with Biotest AG for the full commercialization and distribution of the immunoglobulin therapy Yimmugo® in the U.S., following its Biologic License Application (BLA) approval by the FDA on June 13, 2024.
Immunoglobulin therapies, such as Yimmugo®, are essential in managing primary immunodeficiencies (PID), which affect approximately 500,000 people in the U.S. They play a crucial role in preventing infections, enhancing immune function, and improving the quality of life for patients.
"Kedrion is proud of our role in addressing rare immune system deficiencies by making Yimmugo® accessible to patients in the U.S.," said Ugo Di Francesco, CEO of Kedrion Biopharma. "Biotest has been an excellent collaborator, and we look forward to exploring further opportunities. This significant new arrangement is part of our larger strategy to address unmet patient needs in antibody immunodeficiency."
As Kedrion currently distributes two of the fastest-growing injectable immunoglobulin (IG) therapies in the U.S., the company is well-positioned for successful commercialization and distribution of Yimmugo®. Subject to finalizing the definitive long-term agreement, Biotest is expected to begin supplying Yimmugo® to Kedrion in Q4 2024, with a market launch planned for Q1 2025.
The U.S. IG market is expected to grow by roughly 9% per year in the next eight years, representing an increasing patient need for the product. Distributing Yimmugo® allows Kedrion to remain at the forefront of meeting this market need and reaching a greater portion of the PID patient population.
Yimmugo® is produced using a state-of-the-art process at Biotest's new FDA-certified "Next Level" production facility in Dreieich, Germany. The modern production process aims to achieve high product quality and promotes a responsible use of resources.
"Based on Kedrion's proven experience and extensive coverage in this important immunoglobulin market, I am confident that Yimmugo® will be a commercial success in the U.S. and provide a meaningful treatment option to patients." said Peter Janssen, CEO of Biotest AG.
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