Lek introduces Lisinopril in the US market

2. 7. 2002

Ljubljana, July 1 – The Slovenian pharmaceutical company Lek announces that it has received final approval from U.S. regulatory authorities to immediately start the distribution and sales of the ACE inhibitor Lisinopril in the U.S. The American market is the largest single pharmaceutical market worldwide and one of Lek’s strategic markets. Sales of the innovator brands were estimated to be in excess of $ 1.5 billion during 2001.

On July 1, the U.S. Food and Drug Administration (FDA) has granted final approval for Lek to immediately start the distribution and sales of the ACE inhibitor Lisinopril in six dosage strengths. Lek will market the product through its wholly owned subsidiary Lek Pharmaceuticals, Inc. The innovator, Astra-Zeneca, co-markets its product with Merck under the respective brand names Zestril and Prinivil. Market data indicate that brand sales were in excess of $ 1.5 billion during 2001, with an increase of more than 10 percent over the previous year. The FDA approval follows the expiration of the innovator’s U.S. patents and market exclusivity periods. FDA approval for the product was also granted to nine other companies at the same time.

Lek’s in-house R&D and manufacturing teams completed all development and manufacturing activities for this product. The Lek product is one of a select few in the U.S. market where the marketer has the advantage of backwards integration into the development and production of the active pharmaceutical ingredient. The Lisinopril approval was the second Lek product approved by the U.S. authorities during 2002. This, once more, confirms that Lek meets the stringent requirements of the American pharmaceutical industry as defined and controlled by U.S. FDA.

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: Miša Komar – Žiberna, Lek’s Corporate Communications Telephone: + 386 1 580 22 43