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.
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