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From: TSS (216-119-139-20.ipset19.wt.net)
Subject: ZLB Behring Receives FDA Approval for New Labeling for Carimune NF on Product Safety Related to TSE Agents
Date: October 12, 2004 at 7:01 am PST

ZLB Behring Receives FDA Approval


ZLB Behring Receives FDA Approval for New Labeling for Carimune NF
on Product Safety Related to TSE Agents

KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Sept. 22, 2004--ZLB Behring today
announced that the U.S. Food and Drug Administration (FDA) has approved
additional labeling information for Carimune(R) NF, its human
plasma-derived intravenous immunoglobulin preparation. The new labeling
includes data from experimental studies that show that manufacturing
steps used in the production of Carimune(R) NF have the capacity to
substantially decrease infectivity of transmissible spongiform
encephalopathy (TSE)(1). TSEs include variant Creutzfeldt-Jakob Disease
(vCJD), the human form of mad cow disease.
To date, there has been no evidence of TSE (also known as prion disease)
transmission through plasma-derived protein therapeutics. Nevertheless,
minimizing the risk of TSE transmission is a primary consideration in
the manufacture of human plasma-derived products.

"The FDA approval for the new labeling on reducing TSE infectivity is an
important milestone that demonstrates our commitment to continuous
improvement and leadership," said Paul Perreault, ZLB Behring Vice
President, U.S. Commercial Operations. "The quality and safety of our
products is ZLB Behring's highest priority in order to ensure the health
and well being of patients who rely on our life-saving therapies."

Experimental Results

The labeling approval is based on the results of experimental studies
that ZLB Behring submitted to the FDA. The studies determined the
capacity in which the manufacturing process for Carimune(R) NF could
decrease the infectivity of an experimental TSE agent, considered a
model for vCJD and other prion diseases. The results have been confirmed
by using two different TSE model systems. The data shows that several
distinct production steps significantly reduce TSE infectivity,
including precipitation (3.5 logs), depth filtrations (7.3 logs) and
nanofiltration (4.4 logs). These steps have also been shown to
contribute to virus inactivation and elimination during Carimune(R) NF
manufacturing. The new results offer further confirmation that even if a
low level of CJD/vCJD infectivity was potentially present in the
starting material, it would be removed.

About Carimune(R) NF

Carimune(R) NF is a sterile, highly purified, plasma-derived Immune
Globulin Intravenous (Human) (IGIV) product used for replacement therapy
in patients who do not produce adequate levels of antibodies (or
immunoglobulins), e.g., those with primary immunodeficiencies, or PID.
These antibodies are essential in fighting infectious diseases.
Carimune(R) NF also is used to treat certain immune-mediated disorders,
such as acute and chronic immune thrombocytopenic purpura (ITP).

Carimune(R) NF is the first IGIV in the United States to employ
nanofiltration - a technology that filters out pathogens above a certain
size.

About ZLB Behring

ZLB Behring is a global leader in the plasma therapeutics industry.
Dedicated to improving the quality of life for patients throughout the
world, ZLB Behring provides safe and effective plasma-derived and
recombinant products and offers patient communities a wide range of
related services. The company's broad portfolio of life-saving
therapeutics are used in the treatment of individuals with hemophilia,
immune deficiency disorders and inherited emphysema; the prevention of
hemolytic diseases for the new born; cardiac surgery patients; and shock
and burn victims. ZLB Behring is a wholly-owned subsidiary of CSL
Limited, a leading biopharmaceutical company based in Melbourne,
Australia, and was formed when CSL acquired Aventis Behring and combined
the business with CSL's existing subsidiary, ZLB Bioplasma, in April
2004. For more information, please visit www.zlbbehring.com
.

Statements in this news release containing projections or estimates of
revenues, income, earnings per share, capital expenditures, capital
structure, or other financial items; plans and objectives relating to
future operations, products or services; future economic performance; or
assumptions underlying or relating to any such statements, are
forward-looking statements subject to risks and uncertainties. Actual
results could differ materially depending on factors such as the timing
and effects of regulatory actions, the results of clinical trials, the
company's relative success developing and gaining market acceptance for
new products, the outcome of significant litigation, and the
effectiveness of patent protection.

References (1) Gregori L et al. Partitioning of TSE infectivity during
ethanol fractionation of human plasma. Biologicals, 2004; 32:1-10.


Creating ZLB Behring, a Global Leader in the Plasma Therapeutics
Industry

At ZLB Behring, we understand the needs of the patients that rely on our
products. For individuals with hemophilia, even minor bleeding can
become life-threatening. Victims of severe trauma and burns struggle
with loss of plasma. While other patients face wounds that won’t heal or
immune systems too weak to fight infection.

As a company with a long combined history of creating a stable supply of
life-saving therapies, ZLB Behring will continue this leadership
tradition by providing plasma and recombinant therapies that make the
difference for millions of patients and those in life-and-death situations.

"The creation of ZLB Behring, as an important part of the CSL Group, is
a watershed for us and for the patients that depend on our products.
Combining ZLB Bioplasma and Aventis Behring creates an organization that
is focused on plasma and recombinant therapeutic products, resulting in
even greater stability in supply over the long-term." says Peter Turner,
President of ZLB Behring. Peter is based in King of Prussia,
Pennsylvania, USA.

Our existing portfolio of high quality products, services and
distribution methods will continue as usual for the time being. We’ve
taken many measures to ensure that this is a seamless transition for
you. As we roll out improvements and changes to our product lines and
customer service, we will be sure to inform you in an immediate and
timely manner.

We are excited about the future of this company and the benefits that
this combination will provide to patients and customers alike. ZLB
Behring has the global scale to lead this industry, with talented
people, efficient manufacturing and plasma collection capabilities and
leading-edge research and development endeavors.

ZLB Behring

http://www.zlbbehring.com/zb/n3658936/detail.htmTSS

KING OF PRUSSIA, Pa., 12.10. 2004 11:10


ZLB Behring Receives FDA Approval for New Labeling for Carimune® NF on
Product Safety Related to TSE Agents

ZLB Behring today announced that the U.S. Food and Drug Administration
(FDA) has approved additional labeling information for Carimune® NF, its
human plasma-derived intravenous immunoglobulin preparation. The new
labeling includes data from experimental studies that show that
manufacturing steps used in the production of Carimune® NF have the
capacity to substantially decrease infectivity of transmissible
spongiform encephalopathy (TSE)1. TSEs include variant Creutzfeldt-Jakob
Disease (vCJD), the human form of mad cow disease. To date, there has
been no evidence of TSE (also known as prion disease) transmission
through plasma-derived protein therapeutics. Nevertheless, minimizing
the risk of TSE transmission is a primary consideration in the
manufacture of human plasma-derived products.

"The FDA approval for the new labeling on reducing TSE infectivity is an
important milestone that demonstrates our commitment to continuous
improvement and leadership," said Paul Perreault, ZLB Behring Vice
President, U.S. Commercial Operations. "The quality and safety of our
products is ZLB Behring's highest priority in order to ensure the health
and well being of patients who rely on our life-saving therapies."

Experimental Results

The labeling approval is based on the results of experimental studies
that ZLB Behring submitted to the FDA. The studies determined the
capacity in which the manufacturing process for Carimune® NF could
decrease the infectivity of an experimental TSE agent, considered a
model for vCJD and other prion diseases. The results have been confirmed
by using two different TSE model systems. The data shows that several
distinct production steps significantly reduce TSE infectivity,
including precipitation (3.5 logs), depth filtrations (7.3 logs) and
nanofiltration (4.4 logs). These steps have also been shown to
contribute to virus inactivation and elimination during Carimune® NF
manufacturing. The new results offer further confirmation that even if a
low level of CJD/vCJD infectivity was potentially present in the
starting material, it would be removed.

About Carimune® NF

Carimune® NF is a sterile, highly purified, plasma-derived Immune
Globulin Intravenous (Human) (IGIV) product used for replacement therapy
in patients who do not produce adequate levels of antibodies (or
immunoglobulins), e.g., those with primary immunodeficiencies, or PID.
These antibodies are essential in fighting infectious diseases.
Carimune® NF also is used to treat certain immune-mediated disorders,
such as acute and chronic immune thrombocytopenic purpura (ITP).

Carimune® NF is the first IGIV in the United States to employ
nanofiltration - a technology that filters out pathogens above a certain
size.

About ZLB Behring

ZLB Behring is a global leader in the plasma therapeutics industry.
Dedicated to improving the quality of life for patients throughout the
world, ZLB Behring provides safe and effective plasma-derived and
recombinant products and offers patient communities a wide range of
related services. The company's broad portfolio of life-saving
therapeutics are used in the treatment of individuals with hemophilia,
immune deficiency disorders and inherited emphysema; the prevention of
hemolytic diseases for the new born; cardiac surgery patients; and shock
and burn victims. ZLB Behring is a wholly-owned subsidiary of CSL
Limited, a leading biopharmaceutical company based in Melbourne,
Australia, and was formed when CSL acquired Aventis Behring and combined
the business with CSL's existing subsidiary, ZLB Bioplasma, in April
2004. For more information, please visit www.zlbbehring.com.

Statements in this news release containing projections or estimates of
revenues, income, earnings per share, capital expenditures, capital
structure, or other financial items; plans and objectives relating to
future operations, products or services; future economic performance; or
assumptions underlying or relating to any such statements, are
forward-looking statements subject to risks and uncertainties. Actual
results could differ materially depending on factors such as the timing
and effects of regulatory actions, the results of clinical trials, the
company's relative success developing and gaining market acceptance for
new products, the outcome of significant litigation, and the
effectiveness of patent protection.

Reference: 1. Gregori L et al. Partitioning of TSE infectivity during
ethanol fractionation of human plasma. Biologicals, 2004; 32:1-10.


Kontaktinformationen:
Mimi Garner
Department: Communications - Global
Phone: +1 610-878-4155
Fax: +1 610-878-4913
Location: King of Prussia Headquarters
Address: P.O. Box 61501
1020 First Avenue
King of Prussia, PA 19406
USA
Email: Mimi.Garner@zlbbehring.com


Name: Philippe Müller
Title: Director
Department: Media inquiries - Switzerland
Phone: +41 31 344 1036
Fax: +41 31 344 1480
Location: ZLB Behring AG
Address: Wankdorfstrasse 10
CH-3000 Bern 22
Switzerland
Email: philippe.mueller@zlb.com

http://www.news-ticker.org/pm.php?news_id=4378046&aktion=nfTSS

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