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DGAP-News Biotest AG: Biotest receives approval in the European Union for the early use of Zutectra(R) after liver transplantation

Nachrichtenquelle: EQS Group AG
12.01.2016, 09:00  |  228   |   |   
DGAP-News: Biotest AG / Key word(s): Regulatory Approval
Biotest AG: Biotest receives approval in the European Union for the early
use of Zutectra(R) after liver transplantation

12.01.2016 / 09:00
The issuer is solely responsible for the content of this announcement.

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/
PRESS RELEASE

Biotest receives approval in the European Union for the early use of
Zutectra(R) after liver transplantation

- Application of the subcutaneous hepatitis B hyperimmunoglobulin
Zutectra(R) already one week after liver transplantation approved

- Market position as a leading provider of hepatitis B
hyperimmunoglobulins strengthened

Dreieich, 12 January 2016. The European Commission has granted marketing
approval to Biotest for the early use of the hepatitis B immunoglobulin
Zutectra(R) after liver transplantation. Before, the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMA) had adopted a positive opinion for the modification of the indication
in November 2015.

While Zutectra(R) could be administered 6 months after liver
transplantation so far, the subcutaneous hepatitis B immunoglobulin can now
be applied already one week after liver transplantation. The positive
assessment is based on the clinical results of the
Zutectra(R)-Early-Use-Study (ZEUS) demonstrating the effective use of
Zutectra(R) in the early phase after liver transplantation.

The early administration of Zutectra(R) contributes significantly to a
safe, more time efficient, less costly patient care and better convenience
for the patient. This enables patients' training for self-medication
already during hospitalisation. All in all, this allows a simplified and
patient-friendly therapy.

The successful enhancement of Zutectra(R) supports the role of Biotest as
leading provider of hepatitis B immunoglobulins.

About Zutectra(R)
Zutectra(R) was specifically developed by Biotest for the long-term
treatment of patients after liver transplantation preventing hepatitis B
virus re-infection. It is worldwide the first ready-to-use hepatitis B
immunoglobulin solution in a pre-filled syringe for subcutaneous
administration and it enables patients for self-medication. This provides
the attending physicians and patients with a less-painful, time-saving and
simpler treatment option. The European Commission has granted marketing
approval to Biotest for the hepatitis B immunoglobulin Zutectra(R) in 2009.
Zutectra(R) is currently marketed in the EU member states and major ROW
markets.

About ZEUS
The international clinical phase III Zutectra Early Use Study (ZEUS)
demonstrates effective and safe switch from high dose intravenous hepatitis
B immunoglobulin (HBIG) to subcutaneous HBIG, Zutectra(R), at the early
phase after liver transplantation. Zutectra(R) was administered
subcutaneously 8 - 18 days after transplantation preventing hepatitis B
virus (HBV) re-infection in patients at risk for hepatitis B virus
recurrence. No treatment failures and no clinical signs of a hepatitis B
virus re-infection after six months of Zutectra(R) prophylaxis with
excellent safety and tolerability data were observed.

About Biotest
Biotest AG is a provider of plasma proteins and biological drugs. 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 medicine. Biotest develops
and markets immunoglobulins, coagulation factors and albumins based on
human blood plasma. These are used for diseases of the immune and
haematopoietic systems. In addition Biotest develops monoclonal antibodies
in the indication cancer of plasma cells and systemic lupus erythematosus
(SLE), which are produced by recombinant technologies. Biotest has more
than 2,200 employees worldwide. The preference shares of Biotest AG are
listed in the SDAX on the Frankfurt stock exchange.

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, www.biotest.de
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
email: investor_relations@biotest.de

Securities' ID No., ISIN ordinary shares: 522720, DE0005227201
Securities' ID No., ISIN preference shares: 522723, DE0005227235
Listing: Prime Standard
Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hannover,
Munich, Stuttgart

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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12.01.2016 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de

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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: investor_relations@biotest.de
Internet: http://www.biotest.de
ISIN: DE0005227235, DE0005227201
WKN: 522723, 522720
Indices: SDAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg,
Stuttgart


End of News DGAP News Service
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427557 12.01.2016

Wertpapier: Biotest Vz.

Themen: Euro, DAX, ISIN


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DGAP-News Biotest AG: Biotest receives approval in the European Union for the early use of Zutectra(R) after liver transplantation

DGAP-News: Biotest AG / Key word(s): Regulatory Approval Biotest AG: Biotest receives approval in the European Union for the early use of Zutectra(R) after liver transplantation 12.01.2016 / 09:00 The issuer is solely responsible for the content of …

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