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.
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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
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"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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SOURCE Kedrion Biopharma