Contractual terms finalized and definitive agreement between Kedrion and Biotest signed based on framework agreed in July
Distribution agreement requires Biotest to supply and Kedrion to purchase minimum quantities of Yimmugo® over the seven-year term
Preparations for launch of Yimmugo® in the United States in 2025 well underway
FORT LEE, N.J., Oct. 2, 2024 /PRNewswire/ — 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 G (IgG) antibody
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% liquidYimmugo® 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 INFORMATIONBOXED WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURESee 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)
About KedrionKedrion Biopharma is a biopharmaceutical company that collects and fractionates blood plasma to produce and distribute worldwide plasma-derived therapies for use in treating and preventing rare and debilitating conditions like Coagulation and Neurological Disorders, Primary Immunodeficiencies, and Rh sensitization, which can lead to Hemolytic Disease of the Fetus and Newborn. Kedrion is a global player in plasma derivatives and rare disease medicines employing 5,100 people worldwide. The company has a plasma collection footprint of 68 centers operated by KEDPLASMA in the United States, and of 8 centers operated by
UNICAplasma and Plasmafera in the Czech Republic, and a portfolio of 37 products distributed in over 100 countries around the world. With these figures, Kedrion is the world’s 5th top player in the field of plasma-derived products. We work on a global scale to expand patient access to plasma-derived therapies. kedrion.com
This release includes “forward-looking statements,” within the meaning of the securities laws and certain other jurisdictions, based on current expectations and projections about future events. All statements other than statements of historical facts included in this release, including, without limitation, statements regarding our future financial position, risks and uncertainties related to our business, strategy, capital expenditures and our plans and objectives for future operations, may be deemed to be forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties. Words such as “believe,” “expect,” “anticipate,” “may,” “assume,” “plan,” “intend,” “will,” “should,” “estimate,” “risk,” “target,” “objectives,” “outlook,” “probably,” “project,” “seek” and similar expressions or the negatives of these expressions are intended to identify forward-looking statements. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Any forward-looking statement speaks only as of the date on which it is made and we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact
Duccio Manetti, Chief Communication Officer: [email protected]; +39 0583 767534
SOURCE Kedrion Biopharma
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