Lek obtains approval to market co-amoxiclav in the US market

26. 11. 2002

Ljubljana, 26 November 2002 – The Slovenian pharmaceutical company Lek d.d. received final approval from the US regulatory authorities (Food and Drug Administration) to immediately start the distribution and sales of the 1-gram tablets of co-amoxiclav (combination of amoxicilline antibiotic and clavulanic acid, beta-lactamase inhibitor), an antibiotic for treatment of broad-spectrum bacterial infections. The US market is the world’s largest pharmaceutical market and one of Lek’s strategic markets. In 2001 the sales of co-amoxiclav by the originator GlaxoSmithKline were in excess of $ 1.7 billion. Lek will launch co-amoxiclav in the US market in the beginning of 2003.

On 21 November 2002, the US Food and Drug Administration (FDA) granted final approval for Lek to immediately start the distribution and sales of 1-gram tablets of co-amoxiclav, an antibiotic for treatment of broad-spectrum bacterial infections. Lek will market the product through its US subsidiary Lek Pharmaceuticals Inc.

The originator, GlaxoSmithKline, markets its product under the brand name Augmentin. Market data indicate that the sales of Augmentin in the USA exceeded $ 1.7 billion during 2001. Since July this year, a generic co-amoxiclav by the US company Geneva has been in the market, about a month ago the Israeli generic company Teva started to market it as well. The FDA approval for 1-gram co-amoxiclav tablets was also granted to the Indian company Ranbaxy, but their sales in the US market have not been initiated yet.

The originator GlaxoSmithKline filed a suit against all generic manufacturers of co-amoxiclav who had filed the registration documentation with the FDA, for alleged unlawful use of business secrets and for unfair competitive practices. Thus the suit against Lek had been anticipated. Lek considers the suit against Lek out of merit.

Co-amoxiklav is Lek’s most widely internationalized product with a well-established presence primarily in the markets of Poland, Croatia, Romania, Russian Federation, EU and the countries of Asia, Africa and Latin America. “Co-amoxiklav is of strategic importance to the Lek Group, and launching the product in the US market is one of the company’s key business orientations”, said Metod Dragonja, President of Lek Board of Management.

The pharmaceutical company Lek will start marketing 1-gram co-amoxiclav tablets in the US market in the beginning of 2003.

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