Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), one of the world’s
leading producers of plasma-derived medicines, today announced that
Biotest, a Grifols Group company, has received approval from the
United States Food and Drug Administration (FDA) for Yimmugo®, an
innovative intravenous immunoglobulin (Ig) therapeutic, to
treat primary immunodeficiencies (PID).
Yimmugo, developed by Biotest, adds to Grifols’
strong franchise of industry-leading intravenous and
subcutaneous Ig treatments at a time of growing demand for
plasma-derived medicines to treat immunodeficiencies, in which a
part of the body’s immune system is missing or does not function
properly, and other medical conditions.
The first U.S.-approved medicine in Biotest’s
portfolio, Yimmugo is produced using a state-of-the-art process at
Biotest’s new FDA-certified “Next Level” production facility in
Dreieich, Germany, which is already approved for production and
marketing in Europe.
The launch of Yimmugo in the U.S. in the second
part of 2024 follows its successful introduction in Europe at the
end of 2022 and is poised to add to Grifols' future revenue growth
and profitability.
Yimmugo is the first of a threesome of Biotest
plasma proteins on the horizon destined for markets including the
U.S. The other two, both in late-stage development, are a
fibrinogen concentrate (FC) to treat acquired fibrinogen deficiency
– it would be the first FC approved for this indication in the U.S.
– and trimodulin, a polyvalent Ig to treat community-acquired
pneumonia (CAP) or severe community-acquired pneumonia (sCAP).
“The addition of Biotest’s Yimmugo to our strong
portfolio of intravenous and subcutaneous immunoglobulins provides
another innovative treatment option for patients with primary
immunodeficiencies who rely on these essential medicines in their
daily lives,” said Roland Wandeler, President Grifols Biopharma
Business Unit.
The strategic acquisition of Biotest and the
integration of its specialized resources has significantly
accelerated Grifols innovation, deepened its product pipeline and
furthered its industry leadership.
About Yimmugo®
(IgG Next Generation)
Yimmugo is a newly developed polyvalent
immunoglobulin G preparation from human blood plasma for
intravenous administration (IVIg). The sugar-free ready-to-use
solution is approved in the US for substitution therapy in primary
antibody deficiency syndromes. Yimmugo is the first approved
product from the new Biotest Next Level production facility. The
modern production process stands for the highest product quality
and an extremely responsible use of resources.
IMPORTANT SAFETY INFORMATION
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 Grifols
Grifols is a global healthcare company founded
in Barcelona in 1909 committed to improving the health and
well-being of people around the world. A leader in essential
plasma-derived medicines and transfusion medicine, the company
develops, produces, and provides innovative healthcare services and
solutions in more than 110 countries.
Patient needs and Grifols’ ever-growing
knowledge of many chronic, rare and prevalent conditions, at times
life-threatening, drive the company’s innovation in both plasma and
other biopharmaceuticals to enhance quality of life. Grifols is
focused on treating conditions across a broad range of therapeutic
areas: immunology, hepatology and intensive care, pulmonology,
hematology, neurology, and infectious diseases.
A pioneer in the plasma industry, Grifols
continues to grow its network of donation centers, the world’s
largest with over 390 across North America, Europe, Africa and the
Middle East, and China.
As a recognized leader in transfusion medicine,
Grifols offers a comprehensive portfolio of solutions designed to
enhance safety from donation to transfusion, in addition to
clinical diagnostic technologies. It provides high-quality
biological supplies for life-science research, clinical trials, and
for manufacturing pharmaceutical and diagnostic products. The
company also supplies tools, information and services that enable
hospitals, pharmacies and healthcare professionals to efficiently
deliver expert medical care.
Grifols, with more than 23,000 employees in more
than 30 countries and regions, is committed to a sustainable
business model that sets the standard for continuous innovation,
quality, safety, and ethical leadership.
The company’s class A shares are listed on the
Spanish Stock Exchange, where they are part of the Ibex-35
(MCE:GRF). Grifols non-voting class B shares are listed on the
Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs
(NASDAQ:GRFS). For more information about Grifols, please visit
www.grifols.com
MEDIA CONTACTS:
Grifols Press Officemedia@grifols.comTel. +34
93 571 00 02
INVESTORS:
Grifols Investors Relations &
Sustainabilityinversores@grifols.com -
investors@grifols.comsostenibilidad@grifols.com -
sustainability@grifols.comTel. +34 93 571 02 21
LEGAL DISCLAIMER
The facts and figures contained in this report
that do not refer to historical data are “future projections and
assumptions”. Words and expressions such as “believe”, “hope”,
“anticipate”, “predict”, “expect”, “intend”, “should”, “will seek
to achieve”, “it is estimated”, “future” and similar expressions,
in so far as they relate to the Grifols group, are used to identify
future projections and assumptions. These expressions reflect the
assumptions, hypotheses, expectations and predictions of the
management team at the time of writing this report, and these are
subject to a number of factors that mean that the actual results
may be materially different. The future results of the Grifols
group could be affected by events relating to its own activities,
such as a shortage of supplies of raw materials for the manufacture
of its products, the appearance of competitor products on the
market, or changes to the regulatory framework of the markets in
which it operates, among others. At the date of compiling this
report, the Grifols group has adopted the necessary measures to
mitigate the potential impact of these events. Grifols, S.A. does
not accept any obligation to publicly report, revise or update
future projections or assumptions to adapt them to events or
circumstances subsequent to the date of writing this report, except
where expressly required by the applicable legislation. This
document does not constitute an offer or invitation to buy or
subscribe shares in accordance with the provisions of the following
Spanish legislation: Royal Legislative Decree 4/2015, of 23
October, approving recast text of Securities Market Law; Royal
Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4
November, and any regulations developing this legislation. In
addition, this document does not constitute an offer of purchase,
sale or exchange, or a request for an offer of purchase, sale or
exchange of securities, or a request for any vote or approval in
any other jurisdiction. The information included in this document
has not been verified nor reviewed by the external auditors of the
Grifols group.
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