Following the agreement of binding terms signed in July 2024, Kedrion Biopharma Inc. and Biotest AG have now finalized the contractual terms of the long-term strategic agreement for the full commercialization and distribution of Biotest Immunoglobulin Yimmugo® in the United States.
The exclusive distribution agreement requires Biotest to supply and Kedrion to purchase minimum quantities of Yimmugo® over the initial seven-year term.
Immunoglobulin therapies, such as Yimmugo®, play a key role in managing Primary Immunodeficiencies (PID), which affect approximately 500,000 people in the US.¹
Production of the quantities needed to enter the United States began immediately after the Biologic License Application (BLA) was approved, and is ongoing. Preparations for the product’s market launch in 2025 are well underway.
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.
With the US market for Immunoglobulin expected to grow by approximately 9% each year over the next eight years, distributing Yimmugo® will enable Kedrion to stay ahead in meeting market demand and reaching more patients with Primary Immunodeficiency disorders.
“At Kedrion, we are committed to understanding the needs of patients and customers, and we are thrilled to bring Yimmugo® to the US market. In this climate of growing demand and awareness for Primary Immunodeficiencies, we see an incredible opportunity to make a meaningful impact on the lives of those who need it most“ said Bob Rossilli, Chief Commercial Officer at Kedrion.
About Yimmugo® (immune globulin intravenous, human – dira), 10% liquid
Yimmugo® is a polyvalent immunoglobulin G preparation from human blood plasma for intravenous administration (IVIg) for the treatment of primary humoral deficiency (PID) in patients 2 years of age or older. Yimmugo® is the first approved product from the new Biotest Next Level production facility.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE
See full Prescribing Information for YIMMUGO.
- Thrombosis may occur with immune globulin intravenous (IGIV) products, including YIMMUGO. (5.3)
- Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. YIMMUGO does not contain sucrose. (5.4)
- For patients at risk of thrombosis, renal dysfunction or renal failure, administer YIMMUGO at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. (2.1, 2.3, 5.3)
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