AstraZeneca files NDA for Zomig in Japan

ASTRAZENECA FILES NDA FOR ZOMIG (ZOLMITRIPTAN) - POTENTIALLY FIRST ORAL TRIPTAN IN JAPAN Japan, April 11, 2000: AstraZeneca today announced that it has submitted a new drug application for Zomig (zolmitriptan) for the acute treatment of migraine with or without aura. Potentially this could be the first oral triptan to be approved in Japan. In a large placebo controlled dose response study completed in Japan, Zomig was shown to significantly reduce the severity of migraine headache, with complete resolution of headache in some patients. There was also a reduction in other migraine associated symptoms such as nausea, vomiting, phonophobia, and photophobia. The pharmacokinetics, clinical efficacy and tolerability were very similar to the results obtained in similar Western studies which have already been used to secure approval in over 60 countries. As in the West, migraine predominantly affects the young population particularly women and therefore impacts on their productivity and daily living. It is estimated that around 9 million people in Japan suffer from migraine. At present migraine is poorly diagnosed and inadequately treated in Japan and many patients suffer significant disability during attacks. Dr Tom McKillop, CEO of AstraZeneca said, "We already know that migraine is more than just a bad headache - it's debilitating and needs to be taken seriously. In the West, the development of the triptans has revolutionised the treatment of migraine. As market leader of the second generation triptans we now have proof that Zomig works as well in Japanese sufferers as it does in the West and can help make a real difference in the lives of these patients. That is why AstraZeneca is very pleased to be in a position to be the first company to seek approval in Japan for a second generation triptan." Further Enquiries: Steve Brown, tel +44 171 304 5033 Lucy Williams, tel +44 171 304 5034 Staffan Ternby, tel +46 8 553 261 07 Mikael Widell, tel +46 8 553 264 28/ 070-311 99 60 Notes to News Editors: Zomig is registered and used in the US and Europe where it is outselling the other second generation of triptans from Merck and GW with sales of $189 million in 1999, a growth of 88% in Constant Currency on the previous year. This is the second J-NDA to be submitted by AstraZeneca KK based on the import of Western data using the ICH E5 guideline, which was implemented in 1998 and allows the use of Western clinical studies as pivotal data for Japanese registration if the pharmacokinetics and pharmacodynamics in Western and Japanese subjects can be shown to be equivalent. The first AstraZeneca KK J NDA filed using the ICH E5 guideline was Arimidex (aromatase inhibitor) filed in November 1999. Sales of AstraZeneca KK were 80 Bn yen in 1999 - recording a growth of 10% over 1998 (calculated on a proforma basis). The legal merger of Astra Japan Ltd and Zeneca KK was completed on January 1st 2000. AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $15 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products. ------------------------------------------------------------ Please visit http://www.bit.se for further information The following files are available for download: http://www.bit.se/bitonline/2000/04/11/20000411BIT00050/bit0001.doc http://www.bit.se/bitonline/2000/04/11/20000411BIT00050/bit0002.pdf