DGAP-News: Biotest AG: Biotest announces clinical trial data for its new investigational Intravenous Immunoglobulin (IVIG) product for the US market
(firmenpresse) - DGAP-News: Biotest AG / Key word(s): Research Update
Biotest AG: Biotest announces clinical trial data for its new
investigational Intravenous Immunoglobulin (IVIG) product for the US
market
11.04.2012 / 16:33
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PRESS RELEASE
Biotest announces clinical trial data for its new investigational
Intravenous Immunoglobulin (IVIG) product for the US market
Dreieich, 11 April 2012. Biotest AG announces the publication of its US
subsidiary Biotest Pharmaceuticals Corporation (BPC), Boca Raton, Florida,
USA of Wasserman et al.,: 'Safety, Efficacy and Pharmacokinetics of a New
10% Liquid Intravenous Immunoglobulin (IVIG) in Patients with Primary
Immunodeficiency.' in the Journal of Clinical
Immunology(Http://dx.doi.org/10.1007/s10875-012-9656-5). The published
clinical data reports the efficacy of a Biotest new investigational IVIG
product, a 10% liquid product, which does not contain any sugar.
The primary investigator, Dr. Richard Wasserman, summarized the results of
the clinical trial: 'Biotest's investigational IVIG product offers a modern
10% liquid and sugar-free immunoglobulin that was well tolerated in the
study patients. The product met the primary and secondary endpoints of the
study. The PIDD (Primary immune deficiency disorder) community will welcome
a new alternative product.'
Dr. Georg Floss, CEO of Biotest Pharmaceuticals Corporation, stated:
'Biotest Pharmaceuticals has diligently worked to develop this new IVIG 10%
liquid specifically for the US market. Biotest is confident that this
product will provide patients a unique alternative from a new source with a
long legacy of dependability and quality around the world. We look forward
to providing this new product to the US Healthcare system from our facility
in Boca Raton, Florida, USA.'
The study followed 63 patients with defined primary antibody deficiency for
12 months. All patients maintained an average serum IgG (immunoglobulin)
level above 500 mg/dL.
The primary efficacy endpoint, the rate of acute serious bacterial
infections (SBI)(0.035 SBI/patient-year), was well below the FDA target of<=1.0 SBI/patient-year.
Among other efficacy parameters, the rate of days away from work or school
due to infection was 2.28 days/patient-year. Additionally, 63.8% of
patients in the trial did not miss a day of work or school.
Earlier this year Biotest's investigational IVIG virus validation data was
published in Results in Immunology: Dichtelmüller et al.:'Effective virus
inactivation and removal by steps of Biotest Pharmaceuticals IGIV
production process.' (Immunology (Vol 2, 2012, pp 19-24)). The virus
validation experiments concluded that the three virus inactivating and/or
removal steps employed in Biotest's manufacturing process are robust and
effective.
Biotest is currently seeking marketing approval from the FDA for this
investigational IVIG product based upon these and other clinical data.
Biotest expects a decision regarding such approval sometime in the first
half of 2012.
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.
About Biotest Pharmaceuticals Corporation
Biotest Pharmaceuticals Corporation was created as a wholly-owned US
subsidiary of Biotest AG in December 2007. Innovative technologies and a
sharp focus on safety are incorporated into every facet of the business.
From plasma collection to product manufacturing and distribution - from
nature for life - Biotest Pharmaceuticals Corporation is committed to
maintaining these same high standards of excellence. For inquiries about
the US market, please contact Douglas Loock at +1 561 989 5732.
Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, www.biotest.de
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
e-mail: investor_relations(at)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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11.04.2012 Dissemination of a Corporate News, transmitted by DGAP - a
company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
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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(at)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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