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Pall and Viragen
Sign Agreement to Recover White Blood Cells from Blood
Filters; Discarded Leukocytes Are Potential Source
for Treating Hepatitis C
East Hills, NY and Plantation,
FL - January 31, 2000 - Pall Corporation
(NYSE: PLL) and Viragen, Inc. (AMEX: VRA) announced
they have entered into a development and licensing
agreement to recover white blood cells (leukocytes)
from blood filters. Pall will grant exclusive, worldwide
license (except Japan) to proprietary technology that
will enable Viragen to efficiently remove and recover
leukocytes from used leukoreduction filters. The goal
is to provide additional sources of leukocytes for
Viragen's production of interferons for therapeutic
use. Viragen's lead product, Omniferonâ„¢,
a multi-subtype alpha interferon, is currently in
Phase II clinical trials in Europe for the treatment
of hepatitis C, a disease estimated to afflict tens
of millions worldwide. Omniferonâ„¢
is derived from white blood cells using Viragen's
unique manufacturing technology. Viragen has white
blood cell sourcing agreements with various blood
organizations including the American Red Cross, America's
Blood Centers and the German Red Cross.
Sam Wortham, Medical Division President
of Pall Corporation stated, "The recovery of
leukocytes, now essentially a medical waste, and transforming
them into a valuable pharmaceutical holds great promise.
We are excited to work with Viragen as we expand our
activities in biotechnology."
Most blood collected for transfusions
is separated into red blood cells, platelets, and
plasma. The remaining component called buffycoat consists
of white blood cells. These cells fight disease and
make the immune system function in the blood donor,
but can cause adverse transfusion reactions in the
transfusion recipient. White blood cells are traditionally
sourced from buffycoats. Donor blood can be leukocyte
reduced by filtration to remove the donor's white
blood cells and protect the transfusion recipient.
"Blood centers normally discard
blood filters after each use. The potential access
to all filtered white blood cells increases Viragen's
capability to maximize production of Omniferon,"
said Gerald Smith, Chairman & CEO of Viragen.
"This agreement with Pall may now provide us
with additional quantities of white blood cells especially
as leukoreduction continues to grow as the standard
for blood collection agencies."
The agreement with Viragen represents
the first license granted by Pall's Cell Therapy Group.
The Group is focused on utilizing Pall's extensive
technology portfolio and expertise in blood filtration
and separation to serve such areas as molecular biology
and drug discovery (including DNA and protein detection
procedures), stem cell and cord blood research and
other applications in cell harvesting and purification,
adoptive immunotherapies and cytokine production.
About Pall Corporation
Pall is the leader in the rapidly growing filtration
and separations industry. Pall serves customers throughout
the health care and industrial marketplace, including
leading edge products for use in transfusion medicine,
biopharmaceuticals, semiconductors, municipal drinking
water, aerospace and a host of other industries. Pall
blood filters are used in all ten countries that have
mandated universal leukocyte reduction and in the
14 countries, including the U.S., that are moving
toward routine blood filtration.
In addition to blood filtration,
Pall is involved in extensive research and development
in many other areas of blood safety including co-developing
INACTINEâ„¢ Pathogen Inactivation
Technology with V.I Technologies, currently in Phase
II clinical trials. The INACTINEâ„¢
Pathogen Inactivation Technology uses chemistry targeted
at nucleic acid to inactivate viruses, bacteria, and
other pathogens in transfusion blood products. Pall
has the exclusive marketing rights to INACTINEâ„¢
for both red cells and platelets.
Pall has annual sales of over $1.2
billion. The Company is headquartered in East Hills,
New York and has operations in over 30 countries.
About Viragen, Inc.
Viragen, Inc. is engaged in the research, development
and manufacture of immunomodulatory therapeutic products
including natural human interferon and human monoclonal
antibodies for the treatment of various life-threatening
and debilitating diseases such as hepatitis B &
C, multiple sclerosis and cancer.
In addition to developing a portfolio
of proprietary drug products, Viragen is engaged in
a project to deliver efficient alternatives to the
biotech and pharmaceutical industry for the large-scale
production of proteins and monoclonal antibodies necessary
for drug development and their commercialization.
Viragen has signed a collaborative
agreement with the Roslin Institute, the internationally
renowned center for biotechnology known for their
creation of "Dolly the Sheep." Viragen has
been granted a worldwide exclusive license by the
Roslin Institute to their avian (bird) technology
to enable Viragen to produce drugs, including monoclonal
antibodies to fight cancer and other life-threatening
diseases, inside the eggs of specially created transgenic
chickens. Vast amounts of novel and powerful drugs
are required to treat many diseases for which there
is currently very limited production capacity. Avian
technology will target the production of Viragen's
portfolio of anti-cancer drugs as well as address
the needs of the entire biotech and pharmaceutical
industry for large-scale protein and monoclonal antibody
production. The development of avian technology promises
a much faster, cost-effective and virtually unlimited
production process marked by the chicken's prolific
egg laying capabilities.
Viragen's Oncology Project includes
collaboration with Memorial Sloan-Kettering Cancer
Center for the development of a human monoclonal antibody
for the treatment of melanoma and other cancers. Viragen
has also been granted a worldwide exclusive commercial
license by the U.K.'s Cancer Research Campaign to
develop a cancer vaccine for the treatment of several
indications including breast, ovarian and colorectal
cancers. The U.S. National Institutes of Health (NIH)
have also granted Viragen an exclusive worldwide license
for a technology to treat cervical, breast and lung
cancers.
Produced in its Scottish facility,
Viragen's lead product, Omniferon, is currently in Phase
II clinical trials in Europe for hepatitis C, a disease
estimated to afflict tens of millions worldwide. Viragen
has a collaborative agreement with the Common Services
Agency of the United Kingdom; preferential access to
the white blood cells collected by the German Red Cross
and America's Blood Centers; and a white blood cell
agreement with the American Red Cross. Other Corporate
collaborations include agreements with Merck-Biovation,
Cryolife, Inc., Valentis, Inc. and Zonagen, Inc. The
foregoing press release contains forward-looking statements
that can be identified by such terminology such as "expects",
"potential", "suggests", "may",
"will", or similar expressions. Such forward-looking
statements involve known and unknown risks, uncertainties
and other factors that may cause the actual results
to be materially different from any future results,
performance or achievements expressed or implied by
such statements. In particular, management's expectations
regarding future research development results could
be affected by, among other things, uncertainties relating
to clinical trials and product development; unexpected
regulatory delays or government regulation generally;
the Company's ability to obtain or maintain patent and
other proprietary intellectual property protection;
and competition in general. Company
Contacts:
Pall
Corporation:
Judy Angelbeck, Ph.D. Senior Vice
President, Cell Therapy Division
(516) 484 3600 ext. 4066; E-mail: Judy_Angelbeck@pall.com
Diane Foster, Director of Investor
Relations
(516) 484-3600 ext. 6109; E-mail: Diane_Foster@pall.com
For additional company information,
please visit our web site at http://www.pall.com.
Viragen, Inc.:
Mel Rothberg, Executive Vice President
Phone: (954) 233-8746 Fax: (954) 233-8743; E-mail:
mrothberg@viragen.com
Douglas Calder, Director of Communications
(954) 233-8746; Fax (954) 233-8743; E-mail: dcalder@viragen.com
For more information please
visit our Web site at http://www.viragen.com
or contact "Company News On Call" at (800)
758-5804, followed by extension 116574.
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