Preliminary results from the first Phase lll-study of the ETEC-vaccine

3/29/2000 3:16 AM EST

There are two phase III studies for the candidate ETEC vaccine against
travellers diarrhoea both coordinated by Johns Hopkins School of Hygiene
and Public Health in Baltimore, USA. These are in Guatemala and in Mexico.

The first study, with Professor David Sack as principal investigator,
comprising 671 travellers has recently been completed.

Data analyses show that the primary clinical endpoint as defined was not
met i.e. protection against travellers' diarrhoea caused by vaccine
preventable ETEC infection. However, further preliminary analyses indicate
a trend for protection against moderate to severe diarrhoea as opposed to
mild cases. As a consequence an application for registration in Europe can
not be submitted this year as planned.

More analyses are ongoing including laboratory parameters. The data from
the first study will give us valuable information for the further
development of the clinical program.

The second study started in November 1999 in collaboration with SmithKline
Beecham Biologicals, licensee for the worldwide rights outside the Nordic
countries. Recruitment should be completed this summer. So far the study
has included more than 200 travellers and the work is progressing well.
This study is conducted with vaccine produced in accordance with the
commercial product specification.

Lund 29 March 2000

Active Biotech AB (publ)

Sven Andréasson
President & CEO

Active Biotech AB is a Swedish biotechnology group focused on the research
and development of pharmaceuticals and vaccines; our core competence being
our knowledge of the human immune system. We have a high quality project
portfolio and considerable financial resources. Important products include
our Dukoral, SBL Cholera Vaccine, a vaccine against tourist diarrhoea
(ETEC), innovative drugs against MS (SAIK) and cancer (TTS). The turnover
of Active Biotech was SEK 267 million in 1999.

Active Biotech AB
Box 724, S-220 07 Lund, Sweden
Tel +46 46-19 20 00
Fax +46 46 19 20 50
E-mail