US Appeals Court Rejects GlaxoSmithKline Appeal

Path Paved for Lek to Continue Sales of Co-Amoxiclav

25. 11. 2003

Ljubljana, 25 November 2003 – After the settlement signed in July of 2003 between GlaxoSmithKline PLC (GSK) and Novartis, including Lek d.d. Ljubljana, Lek Pharmaceuticals Inc. and Lek Services Inc., USA, Lek’s sales of their successful product on the American market were given further support at the end of last week by the US Court of Appeals for the Federal Circuit, which passed a decision revoking a total of seven GSK patents for their antibiotic Augmentin.

At the end of October 2002 GSK filed a lawsuit in North Carolina against Lek d.d., Ljubljana, Lek Pharmaceuticals Inc. and Lek Services Inc., USA, in connection with their product Co-amoxiclav. On the basis of the settlement signed in July 2003 between GSK and the Novartis companies, which included Lek’s companies, their lawsuit was withdrawn and the process was terminated.

Another major part of the patent risk associated with sales of Co-amoxiclav was removed by the US Court of Appeals for the Federal Circuit, which on 21 November upheld the decision of the Circuit Court on the revoking of GSK’s seven patents for the antibiotic Augmentin (Augmentin is a combination of two ingredients: the penicillin amoxicillin and a chemical substance called clavulanic acid).

This eliminated a further obstacle to generic manufacturers of Co-amoxiclav, which include Lek d.d., allowing them to continue supplying the market with the safe and effective generic drug Co-amoxiclav. Lek d.d. will therefore continue to sell their product on the American market, the world’s largest pharmaceuticals market and one of Lek’s strategic markets, where we have been operating since the beginning of 2003 through our US subsidiary Lek Pharmaceuticals Inc.

This press release contains statements and conclusions based on projections of Lek’s future business operations. These estimates are derived from the best information currently available. In case these forecasts prove unreliable, the actual results could prove different from those projected.

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For additional information, please contact: + 386 1 580 22 43 Katarina Klemenc Dinjaški, Lek’s Corporate Communications