Biotest consolidates its outstanding position in the hepatitis B hyperimmunoglobulin market with the marketing authorisation of Fovepta and with the initial sales of Hepatect(R) in Brazil
Biotest AG / Key word(s): Miscellaneous
23.04.2012 / 12:19
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PRESS RELEASE
Biotest consolidates its outstanding position in the hepatitis B
hyperimmunoglobulin market with the marketing authorisation of Fovepta and
with the initial sales of Hepatect(R) in Brazil
- Marketing authorisation of Fovepta(R) in Germany
- Initial sales of Hepatect(R) in Brazil
- Continuation of the clinical development of Civacir(TM) planned for
the second half of 2012
Dreieich, 23 April 2012. Biotest AG obtained marketing authorisation from
the Paul Ehrlich Institute for Fovepta(R), a hepatitis B
hyperimmunoglobulin, in late March. Fovepta(R) provides immunoprophylaxis
when administered subcutaneously to the newborn babies of mothers infected
with hepatitis B. It was developed specifically for use in newborns and can
be applied as subcutaneous injection that is particularly gentle for them.
It is much better tolerated than the common intramuscular products.
Fovepta(R) comes in a prefilled syringe, with the choice of needle left to
the clinician.
Marketing authorisation in Germany provides a basis for further
international regulatory approvals in other countries. Fovepta(R) was
developed particularly for markets with high rates of viral hepatitis B
infection. Obtaining marketing authorisation for Fovepta(R) in Asian and
South American markets, e.g. Brazil, is therefore a high priority.
In January this year, the Journal of Perinatal Medicine accepted the
article 'An open-label, randomized efficacy and safety trial of
subcutaneous and intramuscular BT088 (Fovepta) human hepatitis B
immunoglobulin in neonates of HBV-carrier mothers.' (Buxman et al).
This product allows Biotest AG to consistently expand its hepatitis B
hyperimmunoglobulin portfolio worldwide.
Hepatect(R) given i.v. in the perioperative and early maintenance
transplantation period
Nabi HB(TM) given i.m. after needlestick injuries, for newborns of
hepatitis B-infected mothers and when dealing with
hepatitis B virus infection (only for the US market)
Zutectra(R) subcutaneous for self-treatment at home following
transplantation
Fovepta(R) subcutaneous for newborns of hepatitis B-infected mothers
Biotest is today the global market leader with hepatitis B immunoglobulins
for prophylaxis of reinfection after liver transplantation. Besides Nabi
HB (TM)in the American market, we are working towards further international
expansion of the hepatitis B portfolio. Zutectra(R) is coming onto the
market in France, Switzerland and Spain in the first half of 2012.
After setting up Biotest Farmacia in Brazil, we have now achieved initial
sales of Hepatect(R) and will now devote all our efforts to obtaining
marketing authorisation in this country for Zutectra(R) and Fovepta(R) to
gain the hepatitis B market for Biotest.
The hyperimmunoglobulin Civacir (TM)is being developed at Biotest for the
much more common hepatitis C reinfection prophylaxis following liver
transplantation. Continuation of clinical development is planned in the USA
in the second half of the year following reformulation of the product.
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.
About Biotest
Biotest is a provider of pharmaceutical and biotherapeutic 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
application of clinical immunology, haematology and intensive medicine. In
its Plasma Protein segment, 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 the
Biotherapeutic segment, Biotest researches into the clinical development of
monoclonal antibodies, including in the indications of rheumatoid arthritis
and cancer of plasma cells. Biotest has more than 1.600 employees
worldwide. The preference shares of Biotest AG are listed in the SDAX on
the Frankfurt stock exchange.
Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, www.biotest.de
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
e-mail: investor_relations@biotest.de
fax: +49 (0) 6103 801-347
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,
München, Stuttgart
End of Corporate News
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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: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, Hamburg, Stuttgart
End of News DGAP News-Service
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