Lek receives the tentative approval to sell the drug lisinopril, used in the treatment of hypertension, on the American market - Lek realizes its set objectives and strategic goals, and strengthens its position on the highly competitive American pharmaceutical generic market

Lek on the American Market with Lisinopril

24. 12. 2001

Ljubljana, December 24 – The Slovenian pharmaceutical company Lek announces that it has received tentative approval from US regulatory authorities to market the anti-hypertensive product lisinopril in the U.S. market immediately after the exclusive rights for pediatric use of the originator Merck & Co. expire. The American market is the largest pharmaceutical market in the world and one of Lek’s strategic markets. Lisinopril is one of the best selling drugs for the treatment of hypertension in the American market. Sales of the innovator’s brands are estimated to reach $ 1.5 billion in 2001.

On December 19, the Food and Drug Administration (FDA) granted the Slovenian pharmaceutical company Lek tentative approval to market the anti-hypertensive product lisinopril. This approval gives Lek the right to enter the American market with this drug, immediately after the originator’s patents expire. Lek will market the drug in six different strengths through its own subsidiary.

Merck & Co. has the patent for lisinopril on the American market. Lisinopril is the best selling ACE inhibitor on the American market. In 2001, the sales of both Zestril and Prinivil, the original drugs, are estimated to reach about $ 1.5 billion. The exclusive patent rights for pediatric use expires June 29, 2002. After this date, the way will be open for Lek’s lisinopril, along with five other generic companies at the moment, to enter the highly demanding and competitive American generic market. After the originator’s rights expire, the generic drugs usually take over the majority of the market share. The sales of Lek’s lisinopril will depend on the number of other generic companies that will enter the market after June 29, 2002. Winning timely approval for the finished products lisinopril for the American pharmaceutical market, once again confirms that Lek fulfills the tough demands of the American pharmaceutical industry defined and controlled by Food and Drug Administration. Thus Lek realizes its established objectives and strategic goals, as well as strengthens its position on the demanding and highly competitive American pharmaceutical generic 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.

  • * *

For additional information, please contact Katarina Klemenc, Head of Corporate Communication Department, Lek d.d. Telephone: + 386 1 580 22 43