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Axis Genetics signs first manufacturing agreement for Hepatitis B edible plant vaccines with American Ag-Tec
Cambridge, United Kingdom
November 11, 1998

Axis Genetics plc, Cambridge, United Kingdom, has signed its first manufacturing agreement for the production of hepatitis B Edible Plant Vaccine (EPV) potatoes, with American Ag-Tec International Ltd.

Under the agreement, Axis Genetics will be supplied with EPV potatoes both for use in its oral hepatitis B clinical trial scheduled to begin in 1999 in the US, and for further product development. Axis Genetics is developing a stable, oral formulation of these novel vaccines using existing food processing technologies.

American Ag-Tec International was selected for its expertise in pioneering and patenting a technique for the rapid multiplication of disease-free potato minitubers, not restricted by seasonal or geographic limitations. American Ag-Tec will utilise their patented Quantum Tubers® the process for multiplication of EPV potatoes, using certified stocks of potatoes to produce a consistent product to meet Good Manufacturing Practice standards.

"By investing now we will ensure compliance with production protocols demanded by the FDA and other regulatory authorities," said Dr Iain Cubitt, the Chief Executive of Axis Genetics. "We want to ensure that no procedure in the development chain holds back the commercialisation of these novel vaccines".

The new agreement with Axis Genetics is American Ag-Tec's first venture into the pharmaceutical sector.

"This is an advancement that will revolutionise vaccination programmes. It has its roots in agriculture and will raise the importance of the lowly potato by a quantum leap" said Robert G. Britt, President of American Ag-Tec International Ltd.

Axis Genetics licensed the EPV technology from the Boyce Thompson Institute (BTI) of Ithaca, New York, in May 1998. Preliminary animal studies conducted by the BTI and Roswell Park Cancer Institute of Buffalo, New York, indicated that potatoes modified to produce hepatitis B antigens have potential as vaccines to prevent hepatitis B infection. Further animal studies will be conducted using hepatitis B EPV potatoes, under a collaboration and option agreement between Axis Genetics and Roswell Park Cancer Institute, as reported in an accompanying announcement.

American Ag-Tec International Ltd., based in Delavan, Wisconsin is an international agricultural technology development company working in seed and food production worldwide. The recent development of the Quantum Tubers technology for pathogen-free seed potato is the only technology of its kind with origins in production agriculture as well as in space through the NASA research program at the University of Wisconsin, Madiston (WCSAR).

Axis Genetics is a private company based in Cambridge, UK, developing vaccines from plants. The company is working with the Boyce Thompson Institute for Plant Research, Ithaca, New York, to develop Edible Plant Vaccines for the prevention of hepatitis B, enterotoxigenic E. coli travellers' diarrhoea, and Norwalk virus infections. Using its proprietary chimaeric virus particle technology EPICOAT, Axis is developing vaccines for cancer, Pseudomonas aeruginosa and Staphylococcus aureus infections.

For further information on the company, or to interview Dr Iain Cubitt, Chief Executive of Axis Genetics, please call Jean Garon PR at +44 (01628) 483040, fax +44 (01628) 486796 or e-mail jean@garonpr.demon.co.uk .

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