March 17, 2005 08:00 ET

Pall Prion Removal Technology Presented to FDA Blood Products Advisory Committee




MARCH 17, 2005 - 08:00 ET

Pall Prion Removal Technology Presented to FDA Blood
Products Advisory Committee

EAST HILLS, N.Y.--(CCNMatthews - Mar 17, 2005) -

An update on Transmissible Spongiform Encephalopathies (TSEs), including
variant Creutzfeldt-Jakob Disease (vCJD), the human form of "mad cow"
disease, was a key topic at the Food & Drug Administration's Blood
Products Advisory Committee meeting in Gaithersburg, Maryland today.
Issues such as the number of people that could be harboring vCJD as
carriers, the impact on the blood supply and new risk reduction measures
were addressed. Pall Corporation (NYSE:PLL) presented an overview of the
latest research on its prion reduction technology as a new risk
reduction measure to help prevent transfusion transmission of infectious
prions that can cause vCJD. The Company expects to launch the new filter
commercially in Europe this spring.

TSEs, also called prion diseases, are fatal neurodegenerative diseases
that include vCJD in humans; bovine spongiform encephalopathy (BSE) in
cattle; chronic wasting disease (CWD) in deer, elk and moose; and
scrapie in sheep. These diseases are believed to be caused by prions,
which are misfolded, or "rogue", infectious proteins.

"So much remains unknown about prion diseases even as new information
comes to light practically daily. No one really knows how many people
may be harboring vCJD without clinical symptoms and could potentially
transmit the infection via blood transfusion," according to Joseph
Cervia, MD, a leading infectious disease expert and medical director of
Pall Corporation.

He outlined the myriad questions and uncertainties surrounding vCJD and
other prion diseases. These include the length of the incubation period
from time of exposure to the onset of symptoms; the number of people
potentially harboring vCJD who are asymptomatic; the relationship to
other neurodegenerative diseases including Alzheimer's Disease; and
whether other prion diseases, such as CWD found in elk and deer across
the U.S., can also cross the species barrier to humans, as is the case
with BSE in cows.

"We do, however, know for certain that vCJD is a devastating, invariably
fatal disease and that everything possible should be done to prevent its
spread and ensure the safety of the blood supply," he stated. "Removing
prions from blood prior to transfusion is an approach that can lead to a
greater reduction of risk and also mitigate the issue of blood
availability due to donor deferrals."

The Pall Leukotrap® Affinity Prion Reduction Filter simultaneously
reduces leukocytes (white blood cells) and all types of prions from red
blood cells in a single step. Red cells are the most widely transfused
blood component. Leukoreduction of blood is approximately 40 percent
effective in reducing risk of vCJD infection, but is not sufficient
since prions can be both cell-associated (in leukocytes) and non-cell

Dr. Cervia described the results of studies that show the novel
technology concurrently reduces both leukocytes and prions (cell and
non- cell associated) from red cell concentrates with a 99 percent
reduction of the infectious agent. The research, conducted with vCJD and
scrapie prions, showed that the new filter removed the infectious prions
to below the limit of detection of the Western blot assay. Dr. Cervia
also described the results of studies demonstrating that the filter does
not damage red cells thereby not impacting their efficacy, purity and
therapeutic value.

Dr. Cervia emphasized the need to balance the efficacy of current
measures to prevent the transmission of vCJD via blood transfusion --
specifically donor deferral -- against the safety and availability of
life-saving blood components. A loss of one percent of donors involves
approximately 75,000 to 85,000 individuals in just the first year with a
reverberating impact on blood availability.

Currently, several nations, including the U.S. and Canada, defer blood
donors who have stayed in some countries where BSE has been found.
Japan, which recently confirmed its first vCJD patient, expanded its ban
on blood donations to anyone who stayed in Great Britain or France for
one day or longer between 1980 and 1996. According to the Japanese Red
Cross Society, this ban would cut potential blood donors by several
hundred thousand people per year and may have a serious impact on the
blood supply.

"We can no longer afford to view vCJD as a disease that is limited to a
few countries but must seriously consider new and better approaches to
prevent this devastating problem from escalating here," added Dr.
Cervia. "Combined filtration of leukocytes and prions is a cost
efficient approach to mitigate potential exposure and it can be easily
integrated with current blood handling logistics and good manufacturing

Following CE mark and commercialization of the filter in Europe, Pall
Corporation plans to discuss this technology with regulatory agencies in
Canada and the U.S. The Company is also studying the new filter as a
device to aid in the detection of BSE in cattle before entering the food

About Pall Corporation

Pall Corporation is the global leader in the rapidly growing field of
filtration, separations and purification. Pall's business is organized
around two broad markets: Life Sciences and Industrial. The Company
provides leading-edge products to meet the demanding needs of customers
in biotechnology, pharmaceutical, transfusion medicine, semiconductor,
water purification, aerospace and broad industrial markets. Total
revenues for fiscal 2004 were $1.8 billion. The Company headquarters are
in East Hills, New York with extensive operations throughout the world.
Visit Pall at

Forward-Looking Statement

This release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995. These statements are
based on current Company expectations and are subject to risks and
uncertainties which could cause actual results to differ materially.
Such risks and uncertainties include, but are not limited to:
fluctuations in foreign currency exchange rates; regulatory approval and
market acceptance of new technologies; changes in product mix and
product pricing and in interest rates and cost of raw materials; the
Company's success in enforcing its patents and protecting its
proprietary products and manufacturing techniques and its ability to
achieve the savings anticipated from its cost reduction initiatives;
global and regional economic conditions and legislative, regulatory and
political developments; and domestic and international competition in
the Company's global markets. Additional information regarding these and
other factors is available on the Web at and is included in
the Company's reports filed with the U.S. Securities and Exchange
Commission. Copies of such reports can be obtained, without charge, at

Editor's Note: Interviews with Dr. Cervia and other experts are
available upon request. Photos and additional information on prions, the
technology and research studies can be found on


Contact Information

    Pall Corporation
    Patricia Iannucci, 516-801-9100