Canadian Approval for PowderJect's Unique Cholera & Travel Diarrhoea Vaccine Dukoral-R-.

Business Editors/Health/Medical Writers

OXFORD, England--(BUSINESS WIRE)--Feb. 25, 2003

PowderJect Pharmaceuticals Plc (LSE:PJP), the world's leading independent vaccines company announced today that it has received regulatory approval from the Canadian authorities for its unique cholera and travel diarrhoea vaccine, Dukoral(R).

Dukoral(R) is an oral, drinkable vaccine that provides protection against diarrhoea caused by Vibrio cholerae (cholera) and enterotoxigenic E. coli (ETEC). Cholera is responsible for severe diarrhoea, and without treatment can result in rapid death, sometimes within hours. ETEC, which tends to result in milder disease, is one of the most common causes of infectious diarrhoea, and the most common cause of diarrhoea in travellers. To date Dukoral(R) has received licences for protection against both cholera and ETEC in 18 countries worldwide(1). A number of other licences are being sought currently, including Europe-wide approval via a European Marketing Authorisation Application that PowderJect submitted in March 2002.

'We are extremely pleased that our patient-friendly, drinkable vaccine Dukoral(R) has now been approved in Canada. Diarrhoea can be a major problem for travellers, and Dukoral(R) is the world's only vaccine that offers protection against both cholera and ETEC. Dukoral(R) has been available in Scandinavia for a number of years, and we are very excited to be able to roll out this innovative vaccine further afield,' said Dr Paul R. Drayson, Chief Executive of PowderJect.

Estimates predict that the world-wide travel diarrhoea vaccine market will be worth $400 million by 2005(2). The Canadian market opportunity consists of approximately 3.5 million travellers per year(3,4,5,6) who are estimated to visit high risk areas for travellers' diarrhoea, namely Africa (excluding South Africa), Asia, the Eastern Mediterranean, Caribbean, Middle East and Central and South America. This is predicted to grow to approximately 4.5 million travellers in five years time(3,4,5,6).

Notes for Editors:

PowderJect, the world's leading independent vaccine company, has its headquarters in Oxford, UK, with facilities located in Europe and the US. With a range of products sold under its Evans Vaccines and SBL Vaccines brands, PowderJect is one of the world's largest vaccines companies and the leading vaccine manufacturer in the UK and Sweden. PowderJect's portfolio of products includes vaccines for influenza, yellow fever, cholera, travel diarrhoea, tuberculosis, polio and tetanus. The company's world-class biologics manufacturing facilities are amongst the largest in Europe, and have approvals from both the US and European regulatory authorities. For further information please visit www.powderject.com

ETEC (enterotoxigenic E. coli) is the type of Escherichia coli that is responsible for most bacterial diarrhoea in developing countries. In these countries the vast majority of diarrhoea is of bacterial origin. As a consequence ETEC is the most common cause of diarrhoea in these high risk areas and is the single largest cause of travel diarrhoea. Diarrhoea is recognised as a significant health problem in the developing world, and with 2 million children dying each year from diarrhoeal diseases it is the second most serious killer of under 5 year olds worldwide.

Cholera is an acute intestinal infection caused by the bacterium Vibrio cholerae. It has a short incubation period, from less than 24 hours to five days, and produces an enterotoxin that causes a copious, painless, watery diarrhoea that can quickly lead to severe dehydration and death if treatment is not given promptly. Cholera is spread by contaminated water and food. Only rarely is cholera transmitted by direct person-to-person contact. When cholera occurs in an unprepared community, death rates can be as high as 50%, although this can be reduced to less than 1% with a well-organised response and well established disease control programme.

Dukoral(R) is the only vaccine available that offers protection against ETEC. In addition to product licenses having been granted in several countries worldwide (Argentina, Canada, El Salvador, Estonia, Guatemala, Honduras, Kenya, Latvia, Madagascar, Mauritius, Mexico, New Zealand, Nicaragua, Norway, Peru, Philippines, Sweden and Thailand), the vaccine is also registered by WHO. In terms of competition, Antex Biologics is clinically evaluating Activax(TM), a combination vaccine for Campylobacter-Shigella-ETEC, while Acambis' oral live attenuated ETEC vaccine is in Phase I.

The injectable cholera vaccine, used previously, is no longer recommended by WHO. Dukoral(R) is the only vaccine recommended and registered by WHO for vaccination of populations at risk of cholera epidemic. For travellers to cholera endemic regions the oral vaccines Dukoral(R) and Orochol are currently available in specific territories from PowderJect and Berna Biotech respectively.

References

1 Argentina, Canada, El Salvador, Estonia, Guatemala, Honduras, Kenya, Latvia, Madagascar, Mauritius, Mexico, New Zealand, Nicaragua, Norway, Peru, Philippines, Sweden and Thailand.

2 World Regional Travel Vaccine Markets. Frost & Sullivan 1999.

3 World Tourism Organisation. Yearbook of Tourism Statistics. 2002 Edition.

4 World Tourism Organisation. News release. 29 January 2002.

5 World Tourism Organisation. Tourism Highlights 2002.

6 World Tourism Organisation. Tourism 2020 Vision.