Kedrion and Biotest Finalize Exclusive U.S. Distribution Deal for Yimmugo®

Kedrion Biopharma Inc. and Biotest AG have reached a significant milestone with the finalization of a long-term strategic agreement for the commercialization and distribution of Biotest’s immunoglobulin product, Yimmugo®, in the United States. This follows the initial binding terms agreed upon in July 2024. Under this exclusive distribution agreement, Biotest will supply and Kedrion will purchase minimum quantities of Yimmugo® for an initial term of seven years.

The primary focus of this collaboration is to address the needs of approximately 500,000 Americans affected by Primary Immunodeficiencies (PID). Immunoglobulin therapies like Yimmugo® are crucial in managing these conditions. The production of Yimmugo® commenced immediately upon the approval of the Biologic License Application (BLA) and preparations are ongoing for its market launch in 2025.

Yimmugo® is produced at Biotest's new, FDA-certified "Next Level" production facility in Dreieich, Germany. This modern facility utilizes advanced production processes that aim to deliver high-quality products while promoting ethical resource use. The demand for immunoglobulin in the US is anticipated to grow by about 9% annually over the next eight years. By distributing Yimmugo®, Kedrion aims to meet this rising demand and extend its reach to more patients with PID.

Bob Rossilli, Chief Commercial Officer at Kedrion, expressed enthusiasm about introducing Yimmugo® to the US market. He emphasized the company's commitment to understanding the needs of patients and customers and highlighted the potential for a significant impact on those suffering from Primary Immunodeficiencies.

Yimmugo® is a polyvalent immunoglobulin G preparation derived from human blood plasma for intravenous administration (IVIg). It is designed for the treatment of primary humoral deficiency (PID) in patients aged two years and older. Yimmugo® is notable for being the first product approved from Biotest’s new production facility.

It is important to note that Yimmugo® comes with critical safety information. The product carries a boxed warning concerning the risks of thrombosis, renal dysfunction, and acute renal failure. Thrombosis can occur with immune globulin intravenous (IGIV) products, including Yimmugo®. Additionally, renal issues such as dysfunction and failure have been noted, particularly in patients predisposed to such conditions. However, Yimmugo® does not contain sucrose, a factor linked to higher incidences of renal problems in other IGIV products.

Patients at risk of thrombosis or renal issues should receive Yimmugo® at the lowest practicable dose and infusion rate. Ensuring adequate hydration before administration and monitoring for signs of thrombosis are recommended precautions. Full prescribing information should be reviewed for a comprehensive understanding of the safety profile of Yimmugo®.

Kedrion Biopharma is a global biopharmaceutical company specializing in the collection and fractionation of blood plasma to produce and distribute plasma-derived therapies. These therapies are instrumental in treating and preventing rare and debilitating conditions such as Coagulation and Neurological Disorders, Primary Immunodeficiencies, and Rh sensitization. Kedrion operates globally, employing 5,100 people and managing plasma collection centers in the United States and the Czech Republic. The company’s portfolio includes 37 products distributed across more than 100 countries, making it the fifth-largest player in the plasma-derived products industry. Kedrion is dedicated to expanding patient access to these essential therapies worldwide.