CASTELVECCHIO PASCOLI, Italy, July 1, 2024 /PRNewswire/ -- Kedrion Biopharma Inc. announced today 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 U.S. Food and Drug Administration (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. 

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)

About Kedrion
Kedrion 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 more than 5,000 people worldwide. The company has a plasma collection footprint of 68 centers operated by KEDPLASMA in the United States, and of 5 centers operated by UNICAplasma 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.

Kedrion places a high value on the welfare of those who benefit from its products, as well as the communities and individuals with whom it collaborates.

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.

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