15th Jun 2005 11:05
AstraZeneca PLC15 June 2005 ASTRAZENECA REFUTES EC'S FINDINGS IN LOSEC DOMINANCE CASE AND APPEALS DECISION AstraZeneca announced today that it does not accept the European Commission'sdecision that it infringed Article 82 EC during the marketing of Losec(omeprazole) in the 1990s, and will appeal the decision to fine the company 60million Euros to the Courts. In AstraZeneca's view, the analysis by the Commission in reaching this decisiondoes not take into account the substantial evidence submitted by the companywith regard to the use of Losec as just one of the treatments available fortreatment of stomach acid disorders. AstraZeneca contends that it acted in good faith and did not make misleadingmisrepresentations to Patent Offices or Courts to obtain supplementaryprotection certificates (SPCs) for Losec. Indeed this matter was so unclearthat it was ultimately decided by the European Court of Justice after severalyears of legal argument. The Court's judgment recognised the difficulty ininterpretation of the SPC Regulation and had no criticism of the Company. In addition, AstraZeneca will argue in its appeal against the decision thatamongst other matters: (S) companies are entirely within their rights to withdraw products; tointroduce new products; and to deal with product registrations as may benecessary. In this case the new Losec (MUPS) tablet formulation in fact offersbenefits over the previous formulation. Moreover the Commission fails torecognise that in any event generic companies could have obtained their ownregistrations of omeprazole on the basis of the extensive published literaturealready available at that time. • The Commission has failed to analyse properly the crucial issue ofrelevant market and the definition of dominance in the pharmaceutical industry.The Commission's interpretation in this case could mean that any innovativeproduct may be considered dominant retrospectively and hence subject to the 'special responsibility' of a dominant company. This could impose unnecessaryadditional burdens which will adversely affect industry competitiveness,contrary to the express aspirations of the Commission in particular in relationto the 'Lisbon' agenda. This is a technically and legally complex case and AstraZeneca fundamentallydisagrees with DG Competition's findings. AstraZeneca will challenge theCommission's decision and appeal the case because of the important negativeimpact on future competitiveness that this narrow analysis of dominance willhave on innovative industry in Europe. A background brief on the case is available at www.astrazeneca.com EndsJune 15, 2005 Media Enquiries: Edel McCaffrey, Tel: +44 (0) 207 304 5034 Steve Brown, Tel: +44 (0) 207 304 5033 Investor Enquiries: Mina Blair, Tel: +44 (0) 207 304 5084 Jonathan Hunt, Tel: +44 (0) 207 304 5087 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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