Milestone for Biotest: US approval for innovative immunoglobulin Yimmugo

EQS-News: Biotest AG / Key word(s): Regulatory Approval
Milestone for Biotest: US approval for innovative immunoglobulin Yimmugo

17.06.2024 / 09:00 CET/CEST
The issuer is solely responsible for the content of this announcement.

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PRESS RELEASE

Milestone for Biotest: US approval for innovative immunoglobulin Yimmugo

  * FDA approval secures significant future sales and earnings growth
    through entry into the world's largest market

  * Manufactured at Biotest's state-of-the-art, FDA-certified 'Next Level'
    facility in Germany

Dreieich, Germany, June 17, 2024. Biotest AG today announced that its
intravenous immunoglobulin Yimmugo® has been approved in the United States
for the treatment of patients with primary immunodeficiencies (PID). At the
same time, the site in Dreieich, Germany, has been certified by the FDA.
Previously, Biotest had already received approval for production and
marketing in European markets.

'With this approval, we aim to increase the availability of and access to
immunoglobulin therapies worldwide, thereby improving patient care,' said
Peter Janssen, CEO of Biotest AG. 'We are very pleased that with Yimmugo® we
can bring a product from Germany to the American market for the first time
in the history of Biotest.'

Yimmugo® is the first drug approved in the U.S. to be manufactured using an
innovative process in the new 'Biotest Next Level' production facility. It
was analyzed for safety, efficacy and tolerability in extensive pivotal
studies.

The U.S. approval was preceded by an approval process with the U.S. Food and
Drug Administration (FDA) in which Yimmugo® and its manufacturing facility
were successfully demonstrated to meet the FDA's approval requirements
within the first cycle and without delay. This is a great achievement for
Biotest's employees and partners, who have worked with great dedication on
the development of the product and the realization of the modern production
facility with state-of-the-art technology.

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 Europe for substitution therapy in
primary antibody deficiency syndromes and secondary immune deficiency, as
well as for immunomodulation in autoimmune diseases such as ITP, GBS, CIDP,
MMN and Kawasaki syndrome. Under the US License Biotest is authorized to
manufacture Yimmugo® for the treatment of primary humoral deficiency (PI) in
patients 2 years of age or older. Yimmugo® is the first approved product
from the new Biotest Next Level production facility. The modern production
process stands for highest product quality and an extremely responsible use
of resources.

About Biotest

Biotest is a provider of biological therapeutics derived from human plasma.
With a value added chain that extends from pre-clinical and clinical
development to worldwide sales, Biotest has specialised primarily in the
areas of clinical immunology, haematology and intensive care medicine.
Biotest develops and markets immunoglobulins, coagulation factors and
albumin based on human blood plasma. These are used for diseases of the
immune and haematopoietic systems. Biotest has more than 2,400 employees
worldwide. The ordinary and preference shares of Biotest AG are listed in
the Prime Standard on the German stock exchange. Since May 2022, Biotest has
been a part of the Grifols Group, based in Barcelona, Spain (
www.grifols.com).

Biotest AG will now also be publishing official press releases via X. You
can find us at: https://twitter.com/BiotestAG

IR contact

Dr Monika Baumann (Buttkereit)

Phone: +49-6103-801-4406
Mail: ir@biotest.com

PR contact

Dirk Neumüller

Phone: +49-6103-801-269
Mail: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

Ordinary shares: securities' ID No. 522720; ISIN DE0005227201

Preference shares: securities' ID No. 522723; ISIN DE0005227235

Listing: Frankfurt (Prime Standard)

Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart,
Tradegate

Disclaimer
This document contains forward-looking statements on overall economic
development as well as on the business, earnings, financial and assets
position of Biotest AG and its subsidiaries. These statements are based on
current plans, estimates, forecasts and expectations of the company and are
thus subject to risks and elements of uncertainty that could result in
significant deviation of actual developments from expected developments. The
forward-looking statements are only valid at the time of publication.
Biotest does not intend to update the forward-looking statements and assumes
no obligation to do so.


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17.06.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS
News - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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   Language:       English
   Company:        Biotest AG
                   Landsteinerstraße 5
                   63303 Dreieich
                   Germany
   Phone:          0 61 03 - 8 01-0
   Fax:            0 61 03 - 8 01-150
   E-mail:         ir@biotest.com
   Internet:       www.biotest.de
   ISIN:           DE0005227235, DE0005227201
   WKN:            522723, 522720
   Listed:         Regulated Market in Frankfurt (Prime Standard);
                   Regulated Unofficial Market in Berlin, Dusseldorf,
                   Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
   EQS News ID:    1925909

End of News EQS News Service
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1925909 17.06.2024 CET/CEST