Lek enhances its competitiveness with a new plant in Lendava

The production of pharmaceutical active ingredients in Lendava began 1985 with gentamycin – an antibiotic used for the treatment of severe infections caused by various types of bacteria. Today as well, the Lendava site is one of rare suppliers of gentamycin for the most demanding pharmaceutical markets. The beginning of the 1990’s marked an important breakthrough in the history of the Lendava site, as it began to produce potassium clavulanate, which is still the key product of this site and will remain so in the future.

Even during the first year of its production, potassium clavulanate ranked among Lek’s ten leading products, and since 1999 it has been its number one. “The production of potassium clavulanate constantly increased and in line with this Lek has made large investments to enhance its production capacities and to build the necessary facilities in Lendava. Potassium clavulanate has thus generated a continuous cycle of investments, which is being concluded now with the construction of a new site for final phases of isolation of potassium clavulanate in the total value of 1.6 billion Slovenian tolars. The production of pharmaceutical active ingredients in Lendava has therefore become an important link in the chain of production capacities for global production of pharmaceutical active ingredients in Sandoz. With the new plant, Lek is clearly implementing the strategy of the Lendava site,” said director of the Lek plant in Lendava, Dr. Aleš Rokavec. Potassium clavulanate produced in Lendava is processed into the finished pharmaceutical form by Lek in Prevalje. Most of the active ingredient has actually been used in this way, i.e. to be formulated into the finished pharmaceutical form within Sandoz. This principle is called vertical integration and it is also one of the essential strategic orientations of Sandoz.

The plant, which will employ 12 people, is in compliance with the strictest requirements for final phases of production of pharmaceutical active ingredients that are stipulated by the Slovene legislation and expected by customers from the most demanding pharmaceutical markets. The latest standards in the field of fire safety and explosion-proof operation, as well as environmental protection, are also taken into account. Compared to the old plant, the new one also has three times the production capacity.

The plant for final phases of potassium clavulanate isolation in Lendava was officially opened by Lek’s CEO Janja Bratoš and the Mayor of Lendava, Anton Balažek M.Sc., together with the director of the Lek plant in Lendava, Dr. Aleš Rokavec.

On this occasion, Anton Balažek said that investments into the company’s growth and development also have a positive impact on the development of the local community. In Lendava, Lek is an important member of the community as it provides employment for almost 300 people, it has developed productive cooperation with various institutions in Lendava and its vicinity over the years and has always operated effectively while respecting all aspects of environmental protection.

In 2004, Lek introduced another new product in Lendava, a hypolipemic which is another basic product of this site. It is an active ingredient for pharmaceutical products – medicines for lowering cholesterol and serum fats (lipids). Since more or less the same equipment is required as for potassium clavulanate, the production of this hypolipemic will take place on the same production line, in alternation, depending on market needs for the two active ingredients. Although the basic production equipment for the two active ingredients is the same, several adjustments needed to be made, including the renovation of microbiological laboratories and construction of new storage areas. The value of this investment was about SIT 1.2 billion. The total capacity of the plant will thus not change, therefore the production of hypolipemic drugs in Lendava will not pose an additional burden on the environment. Appropriate storage premises for hypolipemic drugs are also being constructed in Lendava, as pharmaceutical active ingredients which are not related in terms of therapeutic indications need to be stored separately. In addition, the storage conditions for potassium clavulanate and hypolipemic drugs differ significantly. “The production of hypolipemic drugs will increase Lek’s competitiveness and the significance of its Lendava site. This is because production is nowadays completely globalised and exposed to increasingly greater pressures from competitors, therefore dependency on two products instead of only one will lower the business risks,” believes Dr. Aleš Rokavec.

With hypolipemic drugs, the Lendava site is included in a complex production chain which operates at several production sites within Sandoz. The initial phase of production of the active ingredient is done in Italy, the intermediate one in Lendava, and the final phase at the Mengeš site, which Lek opened in October this year. With hypolipemic drugs, which are the product of our own development and are intended for the global market, Lek will be able to supply the entire Sandoz, the generic part of Novartis.

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  Lek, a Sandoz company, is one of the pillars of leading world generics company Sandoz. It operates as a global development center for products and technologies, as a global manufacturing center for active pharmaceutical ingredients and medicines, as a competence center for the development of vertically integrated products, as a Sandoz competence center in the field of development and manufacturing of biopharmaceutical products and as a supply center for the markets of CEE, SEE and CIS, sales Slovenia and sales services for Sandoz’s global markets. Lek d.d. employs about 3,037 people in various regions and achieved total sales of USD 746.5 million in 2004. For further information please consult http://www.lek.si

Sandoz, a Division of the Novartis group, is a world leader in generic pharmaceuticals. Sandoz develops and markets a wide variety of active ingredients and finished products, including biopharmaceuticals and anti-infectives. Since June 2005 Hexal AG, Germany, and since July 2005, EonLabs Inc. U.S., are part of Sandoz. In 2004, Sandoz employed around 13,400 people worldwide and posted sales of USD 3.0 billion. The combined businesses had pro forma 2004 sales of USD 5.1 billion and more than 20,000 employees.

Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group’s businesses achieved net sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.1 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 91,700 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.