08.11.2016
Biotest AG DE0005227235
DGAP-News: Biotest AG: First patient treated in global clinical phase III study of IgG Next Generation in the indication Primary Immunodeficiency Disease (PID)
DGAP-News: Biotest AG / Key word(s): Research Update
Biotest AG: First patient treated in global clinical phase III study of IgG
Next Generation in the indication Primary Immunodeficiency Disease (PID)
08.11.2016 / 07:00
The issuer is solely responsible for the content of this announcement.
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PRESS RELEASE
First patient treated in global clinical phase III study of IgG Next
Generation in the indication Primary Immunodeficiency Disease (PID)
- Study no. 991 marks the first phase III study in the worldwide clinical
development program for IgG Next Generation, a novel development of our
polyvalent immunoglobulin G
- Study design was agreed with US and European regulatory authorities and
approved by all participating countries
- Results will serve as basis for worldwide approval
Dreieich, 8 November 2016. Biotest AG today announced that the first
patient has been treated in study no. 991 - a phase III study investigating
IgG Next Generation as replacement therapy in patients diagnosed with
primary immunodeficiency disease (PID), a group of disorders in which a
part of the body's immune system is missing or does not function properly.
To establish the basis for worldwide marketing approval the study design
was discussed in detail with two major health authorities, the German Paul-
Ehrlich Institute (PEI), and in the United States the American Food and
Drug Administration (FDA).
The study is planned to include approximately 60 patients and will be
conducted in a total of 24 study sites in the United States, Germany,
United Kingdom, Hungary, Spain and Russia.
IgG Next Generation is being manufactured using a brand new production
process and will be the master product for the Biotest Next Level
manufacturing facility currently under construction. This modern
manufacturing facility, which uses state-of-the-art technologies,
represents Biotest's latest commitment to the global immunoglobulin
markets.
In 2014 the market volume of immunoglobulins solely for the indication PID
in US and EU amounted to approximately EUR 1.5 billion.
About study no. 991
Study no. 991 is a phase III, open label, prospective, multicenter trial
and will investigate the clinical efficacy, safety, and pharmacokinetic
properties of IgG Next Generation as replacement therapy in pediatric and
adult patients diagnosed with primary immunodeficiency disease (PID).
Patients previously receiving IVIG (immunoglobulins for intravenous use)
treatment are switched to infusions with IgG Next Generation and treated
for 12 months. The initial dose and dosage intervals will be kept
consistent with the patient's prestudy IVIG treatment.
The primary objective of this study is to demonstrate that IgG Next
Generation provides effective protection against infection by supplementing
and maintaining a normal level of immunoglobulin in the patients' body.
According to established guidelines on the clinical investigation of
immunoglobulin, the rate of acute serious bacterial infections per patient
year should be less than one to provide substantial evidence of efficacy.
More information about the study design can be found at
www.clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT02810444)
About Primary Immunodeficiency
Primary immunodeficiencies (PI) - also called primary immune disorders or
primary immunodeficiency disorders (PID) - are a group of currently 200
identified hereditary and genetic disorders, in which some of the body's
immune defenses are absent or dysfunctional. It is estimated that worldwide
at least 10 million children and adults may be affected by PI.
One of the most common signs of PI is an increased susceptibility to a wide
range of germs like bacteria, viruses and fungi that can cause infections.
Infections in patients diagnosed with PI are more frequent, longer lasting
or harder to treat than are the infections of someone with a normal immune
system. Patients with PID typically require life-long immunoglobulin
replacement therapy to prevent recurrent infections.
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 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
indications of cancer of plasma cells and systemic lupus erythematosus
which are produced by recombinant technologies. Biotest has more than 2,400
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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08.11.2016 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.
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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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