Lek embarking on technology of the future - PORT1 facility marks milestone for Lek's Biopharmaceuticals - Prime R&D achievement result of strategic decision to enter demanding field

Lek Powers Up New Cell-Culture Production Unit to Manufacture Biopharmaceuticals

5. 2. 2004

Mengeš (Slovenia), February 5, 2004 – Lek pharmaceuticals today inaugurated a new manufacturing plant (PORT1), the first of its kind in Slovenia and Central and Eastern Europe. The plant located in Mengeš (near capital Ljubljana, Slovenia), constructed for the production of biopharmaceuticals, was officially opened today by the President of the Republic of Slovenia, Dr Janez Drnovšek. The new cell-culture facility, which was built in just two years at an investment of more than EUR 18 million, shows Lek’s dedication to further strengthen its research and development and to contribute to Sandoz’s leading position in biopharmaceuticals. Sandoz yesterday inaugurated a new manufacturing plant at its Schaftenau site (near Kufstein) in Tyrol, Austria.

The new manufacturing plant in Mengeš Lek President of the Board of Management Metod Dragonja commented: “After the successfull development stage in biopharmaceuticals this is another milestone for Lek. We are entering a new field of manufacturing in the most demanding and most developed pharmaceutical segment.”

Sandoz Head of Biopharmaceuticals Patrick Vink pointed out: “The opening of our new manufacturing plant in Mengeš is a an important step, both for Lek and for the Global Biopharmaceuticals franchise of Sandoz. The expansion in recombinant cell-culture technology will enhance strongly our capabilities and will enable us to leverage our leading position in the fast growing area of Biopharmaceuticals. It demonstrates the important role Lek plays in the global growth strategies of Sandoz”

Guest of Honour, President of the Slovenian Academy of Sciences and Arts, Prof. Dr Boštjan Žekš, stated that Lek’s example of the application of recombinant technology demonstrates the high level of cooperation between science and the business sector in Slovenia. It shows that companies are implementing state-of-the-art technologies with highly capable staff who are mostly graduates of our universities, that cooperation exists between our research institutions and businesses and that our level of scientific development is on par with the rest of Europe. Lek can serve as an example to other companies.”

Biopharmaceuticals are human proteins (e.g. hormones, insulins, antibodies, etc.) developed for therapeutic applications and manufactured using recombinant DNA technologies. Lek began its own research in genetic engineering already in the nineteen-eighties, thus forming a solid base for the production of recombinant proteins – biopharmaceuticals for therapeutic use.

Visiting the new facility at the opening The new facility is a prime technical, technological and engineering accomplishment of Slovenian know-how and Lek’s experts. In addition, this state-of-the-art technology is designed to operate in an environmentally friendly manner.

Production at the PORT1 facility complies fully with the requirements of the European and American professional standards, good manufacturing practice (GMP) and, of course, Slovenian national and EU legislation.

With its two 200-litre perfusion bioreactors (a total of 150 cubic metres of primary product for the isolation of active biopharmaceutical ingredients per year) the new plant’s production capacity has been designed to ensure production levels allowing global product marketing.

With the opening of the PORT1 cell-culture manufacturing plant, the first of its kind in Central and Eastern Europe, Lek will contribute to Sandoz’s leading position in biopharmaceuticals. Lek will develop, manufacture and market biopharmaceuticals through its own business units, as well as through the Sandoz Group.

The new facility has created more than 20 new jobs for experts in the fields of microbiology, biology, biochemistry, chemistry and pharmaceuticals.

Sandoz new cell-culture production unit, which was opened yesterday, has been built to produce innovative biopharmaceuticals. Completed in just two years for an investment of more than EUR 50 million, the new facility further positions Sandoz as manufacturing partner of choice in this field.

The expansion underscores the strategic importance of Sandoz’ new Biopharmaceuticals franchise. Just a year ago, the company opened a new 13,000 liter fermentation plant for biopharmaceutical production using microbial technology at its neighboring Kundl site. The two new facilities have together created more than 100 highly skilled jobs.

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 Katarina Klemenc Dinjaški, Lek’s Corporate Communication