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Agreement for marketing & distribution of QuantiFERON

Document date: Tue 28 May 2002 Published: Tue 28 May 2002 09:00:08
Document No: 190705 Document part: A
Market Flag: Y
Classification: Other
CELLESTIS LIMITED 2002-05-28 ASX-SIGNAL-G

HOMEX - Melbourne

+++++++++++++++++++++++++
Cellestis Limited and Nichirei Corporation of Tokyo, Japan have today
entered into an agreement for the marketing and distribution of
QuantiFERON(R) products in Japan. This agreement also includes a
collaboration in the clinical testing and registration in Japan of a
second-generation QuantiFER0N(R)-TB product.

"The Japanese Ministry of Health has declared tuberculosis a state of
emergency in Japan, and thus Japan represents a major opportunity for
Cellestis. More than 20 million tests for tuberculosis infection are
conducted every year in Japan" said Dr Tony Radford, Managing
Director of Cellestis." We are extremely pleased to have a company of
Nichirei's size and expertise as our Japanese partner. Nichirei has
excellent infrastructure and distribution networks in Japan, and the
Nichirei Biosciences Division has proven expertise in both gaining
regulatory approval and marketing of medical diagnostics in Japan."

Cellestis Limited develops and markets diagnostics measuring the Cel
mediated Immune system, using its patented QuantiFERON(R) technology.
This includes QuantiFERON(R)-TB, the Cellestis product for the
diagnosis of TB infection, recently approved by the US FDA. Cellestis
is now developing and clinically testing a second-generation
QuantiFERON(R) test for TB with specialised utility in Japan. Unlike
most of the developed world, Japan applies universal and repeated BCG
vaccination against tuberculosis which limits the utility of current
TB diagnostics, and the second generation QuantiFERON(R)-TB test
overcomes this limitation.

Nichirei Corporation is a large and diverse Japanese company, with
businesses in Temperature Controlled Logistics, Foodstuffs, Processed
Foods, Biosciences, and Real Estate. Nichirei Corporation has a staff
of nearly 7,000 employees and had sales of 560,000 million Yen (A$8
Billion) for FY 2001. Nichirei Biosciences develops and sells medical
diagnostic and biotechnology research products in Japan.

"We are excited by the opportunity QuantiFERON(R) offers for a
highly specific TB test in Japan" said Mr Takeshi Ara, Executive
Officer General Manager, Nichirei Biosciences Business Division."
Cellestis and Nichirei will be working together to gain registration
of the second-generation QuantiFERON(R)-TB product. We believe there
is a large medical need for such a product in Japan."

BACKGROUND INFORMATION

Although widely used, particularly in developing nations, BCG
vaccination does not generally prevent tuberculosis infection in
adults, although it is known to reduce mortality from TB infection in
children. Unfortunately, extensive and repeated BCG vaccination, such
as that used in Japan, corrupts tuberculin skin testing (Mantoux
testing) for tuberculosis infection. The BCG organism in the vaccine
is a close relative of the tuberculosis organism and vaccination can
cause false-positive reactions. As a result of this, Japan relies
heavily on chest X-rays to detect early signs of tuberculosis, and
does not have a viable test for the early detection of TB infection.

Although QuantiFERON(R)-TB is less affected by BCG vaccination than
the Mantoux test, the second-generation QuantiFERON(R)-TB product
will employ components which are specific to the TB organism but are
absent from BCG, and will thus be completely unaffected by the BCG
vaccination status of the individual being tested. The second
generation QuantiFERON(R)-TB test will provide Japan with a much
needed diagnostic tool allowing detection of TB infection before it
causes disease, helping to combat the TB problem in Japan.