Astrazeneca submits first regulatory application for its new ppi via european mutual recognition

ASTRAZENECA SUBMITS FIRST REGULATORY APPLICATION FOR ITS NEW PPI VIA EUROPEAN MUTUAL RECOGNITION AstraZeneca today announced that a regulatory application for H199/18, a new proton pump inhibitor (PPI), has been submitted to authorities in Sweden, acting as rapporteur country in the European Union's mutual recognition procedure. The new pharmaceutical contains the active substance esomeprazole. This marks the first step in a global application process, which will be followed by applications in the USA, among other countries. "H199/18 is the first PPI synthesised as an isomer to be available for clinical use, and it is a further evolution in PPI therapy beyond omeprazole", said Dr Martin Nicklasson, Executive Vice President of AstraZeneca's GI Franchise. "This is a significant milestone for AstraZeneca's business in the gastrointestinal area." Further enquiries to: Staffan Ternby, 08-553 261 07/070-557 43 00 Steve Brown, Media Relations, tel +44 171 304 5033 ------------------------------------------------------------ Please visit http://www.bit.se for further information The following files are available for download: http://www.bit.se/bitonline/1999/10/21/19991021BIT00550/bit0001.doc http://www.bit.se/bitonline/1999/10/21/19991021BIT00550/bit0002.pdf