Lek on the American Market with Bromocriptine Mesylate

28. 1. 2002

Ljubljana, January 31 – The Slovenian pharmaceutical company Lek announces that it has received approval from US regulatory authorities to immediately market the dopamine receptor agonist bromocriptine mesylate tablets in the U.S. The American market is the largest pharmaceutical market in the world and one of Lek’s strategic markets. Sales of the innovator’s brands are estimated to be approximately $ 40 million during 2001.

On January 28, the Food and Drug Administration (FDA) granted the Slovenian pharmaceutical company Lek the approval to immediately market the dopamine receptor agonist bromocriptine mesylate. Lek will market the drug through its own US subsidiary. Shipments to the US customers will be made immediately. Novartis, the marketer of the brand ParlodelŇ tablets, generates annual sales of approximately $ 40 million. The patents covering this product have already expired. This approval gives Lek, for the time being, an exclusive market position for the generic version of this compound. Lek’s in-house R&D and manufacturing teams completed all development and production activities for this difficult product. The successful completion of this program is a fine example of Lek’s strategy to develop unique products that differentiate our market position in the industry. Winning approval for the finished Bromocriptine mesylates product for the American pharmaceutical market, once again confirms that Lek fulfills the stringent requirements of the American pharmaceutical industry defined and controlled by the U.S. Food and Drug Administration. Lek, therefore, realizes its established objectives and strategic goals, as well as strengthens its position on the demanding and highly competitive American generic pharmaceutical market.

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 Katarina Klemenc, Director of Corporate Communication, Lek d.d. Telephone: + 386 1 580 22 43