Generic challenge to Losec withdrawn i Canada
® GENERIC CHALLENGE TO LOSEC WITHDRAWN IN CANADA The patent protection for omeprazole, the active substance in Losec, expires in Canada in July 1999. However, due to national patent legislation, in Canada the opportunity for generic competition to Losec has existed since 1996 through compulsory licensing under AstraZeneca's substance patent. AstraZeneca has several other patents approved in Canada, including a formulation patent. For several years, various companies have sought to market generic omeprazole. AstraZeneca has successfully asserted its rights, and no generic product has reached the market to date. In December 1997 the Canadian company Apotex advised it was seeking approval to market three generic omeprazole products and made allegations with respect to AstraZeneca's patents. AstraZeneca responded by filing lawsuits which disputed Apotex' allegations. Recently, the Canadian Federal Court confirmed the cases were terminated based on Apotex' stated wish to withdraw its allegations which gave rise to the litigation. "This clearly shows AstraZeneca's sense of purpose and resolve when it comes to asserting our patent rights," says Dr. Martin Nicklasson, Executive Vice President GI Franchise. "As a result of this decision, we do not expect to see generic competition in Canada in the years immediately ahead, despite the fact that the patent for the active substance, omeprazole, expires in July 1999." @ Sales of Losec in Canada amounted to approximately $185 million in 1998, corresponding to approximately 4% of total sales of the product. Further Enquiries: Media: Mikael Widell, tel +46 8 553 264 28 Steve Brown, tel +44 171 304 5033 +46 70 311 99 60 Rachel Bloom, tel +1 302 886 7858 Investor Relations: Staffan Ternby, tel +46 8 553 261 07 Angus Russell, tel +44 171 304 5100 Ed Seage, tel +1 302 886 4065 Jörgen Winroth, tel +1 609 896 4148 ------------------------------------------------------------ Please visit http://www.bit.se for further information The following files are available for download: http://www.bit.se/bitonline/1999/06/16/19990616BIT00310/bit0001.doc http://www.bit.se/bitonline/1999/06/16/19990616BIT00310/bit0002.pdf