01.03.2017
Biotest AG DE0005227235
DGAP-News: Biotest AG: Recombinant clotting factor VIII with the name Vihuma(R) approved
DGAP-News: Biotest AG / Key word(s): Regulatory Approval
Biotest AG: Recombinant clotting factor VIII with the name Vihuma(R)
approved
01.03.2017 / 07:00
The issuer is solely responsible for the content of this announcement.
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PRESS RELEASE
Recombinant clotting factor VIII with the name Vihuma(R) approved
- Market launch in Germany end of April 2017
- Vihuma(R) is a 4th generation recombinant human factor VIII preparation
from a human cell line
- Vihuma(R) is an optimal portfolio supplement for Biotest
Dreieich, 1 March 2017. Today, the European Commission (EC) has approved
the first, 4th generation human factor VIII preparation manufactured by
Octapharma AG under the name Vihuma(R). Biotest AG will distribute
Vihuma(R) in Germany from the end of April 2017. The approval in
Switzerland has already been applied for and Biotest expects to start
marketing Vihuma(R) in Switzerland in the fourth quarter.
Vihuma(R) is produced from a human cell line and thereby recreates a
natural preparation similar to Biotest's Haemoctin(R), which is derived
from human plasma. In contrast to conventional recombinant factor VIII
preparations made with the aid of hamster cells, Vihuma(R) contains natural
human structures. The similarity of Vihuma(R) to human Factor VIII is
reflected in the name: "human".
Vihuma(R) is indicated for the treatment and prevention of bleeding
episodes in children and adults with haemophilia A (congenital factor VIII
deficiency). It is a high-quality alternative for patients in favor of a
recombinant product to the recombinant factor VIII preparations available
to date. In studies in previously treated patients, the 4th generation
recombinant clotting factor has proved to be safe, effective and well
tolerated.
"With a recombinant factor VIII preparation from a human cell line, which
has many of the advantages of a natural plasma clotting factor, we are
continuing our strategy of using particularly well tolerated preparations,"
states Dr Thomas Becker, Senior Director Haematology of Biotest AG. "We can
now offer an alternative to patients who, together with their doctor,
deliberately opt for a recombinant factor VIII preparation."
About recombinant factor VIII
A recombinant clotting factor VIII is produced using biotechnology and is
not obtained from human plasma. The blueprint (i.e., the gene) for human
factor VIII is introduced into a mammalian cell and inserted into the DNA,
so it "combines" with the existing genetic material. Hamster cells, which
read the human gene and then produce factor VIII, are generally used as in
place of mammalian cells. Despite the incorporated human gene, however, a
hamster cell is not capable of producing a factor VIII that corresponds
exactly to the human model. There are small structural differences that can
affect tolerability. The recombinant factor VIII that Biotest will launch
on the market is produced in a human cell line and thus comes closest to
the natural human model.
About Biotest
Biotest 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
transplant medicine, clinical immunology, haematology and intensive
medicine. Biotest develops and markets immunoglobulins, coagulation factors
and albumins based on human plasma. These are used for diseases of the
immune and haematopoietic systems. In addition Biotest develops monoclonal
antibodies in the indications of cancer of plasma cells and systemic lupus
erythematosus which are produced by recombinant technologies. Biotest has
more than 2,500 employees worldwide. The preference shares of Biotest AG
are listed in the SDAX on the Frankfurt stock exchange.
IR contact
Dr. Monika Buttkereit
phone: +49-6103-801-4406
email: [email protected]
PR contact
Dirk Neumüller
phone: +49-6103-801-269
email: [email protected]
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.de
Ordinary shares: securities' ID No. 522720; ISIN DE0005227201
Preference shares: securities' ID No. 522723; ISIN DE0005227235
Listing: Prime Standard
Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hanover,
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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01.03.2017 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.
Archive at 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: [email protected]
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, Hanover,
Munich, Stuttgart, Tradegate Exchange
End of News DGAP News Service
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