Lek, a Sandoz company, opens the first production facility in Slovenia for drug substances for innovative medicines at its Mengeš site
- The knowledge, long-term expertise and top quality manufacture of drug substances contributed to Novartis’ decision to choose Mengeš, among many other potential sites around the world, as their new production site for technologically demanding drug substances for innovative drug products.
- Lek, a Sandoz company, has brought innovative pharmaceutical production to Slovenia for the first time. Until now, only the production of generic drug substances and drug products has been carried out in Slovenia.
- The investment in the construction of a production facility for drug substances for innovative drug products amounted to more than EUR 28 million and is the largest individual Novartis investment in Slovenia ever.
Today, at the Mengeš site of Lek, a Sandoz company, the first production facility in Slovenia for drug substances for innovative drug products was officially opened in the presence of Dr Miro Cerar, the Prime Minister of the Republic of Slovenia. Lek, a Sandoz company, has thereby brought innovative pharmaceutical production to Slovenia for the first time. Until now, only the production of generic drug substances and drug products has been carried out in Slovenia. The investment in the construction has amounted to over EUR 28 million and is the largest individual Novartis investment in Slovenia ever.
The Mengeš site of Lek, a Sandoz company, has strengthened in recent years and has become an important research-development and production site within Sandoz and Novartis, with both areas of its operation: Drug Substances and Biopharmaceuticals. Egidij Capuder, Head ChemOps Mengeš, a part of which is the new production plant for drug substances for innovative drug products, said: »We play an important role in the development and production of selected high-value drug substances. Our knowledge, long-term expertise and top quality manufacture of drug substances contributed to Novartis’ decision to choose Mengeš, among many other potential sites around the world, as their new production site for technologically demanding drug substances for innovative drug products. This is a great achievement demonstrating that Slovenian expertise is recognized and appreciated by one of the largest pharmaceutical companies in the world.«
»The ChemOps Mengeš unit is known within Sandoz and Novartis as a site that masters the fermentation and chemical synthesis technology and uses highly complex purification techniques with preparatory chromatography. This was one of the synergistic effects of cooperation that convinced Novartis to invest in Slovenia,« stressed Juan Andres, Global Head TechOps at Novartis.
Miro Cerar, the Prime Minister of the Republic of Slovenia, said: "Today's achievement clearly illustrates that more than a decade ago we have made the right decision in recognizing Novartis as a strategic buyer. Despite the challenging economic conditions, Novartis continues to invest in Slovenia. However, the latest investment is of particular importance for both Lek and Slovenia as this marks the first introduction of originator pharmaceutical production to Slovenia. Until now, the pharmaceutical production taking place in Slovenia was limited to the manufacture of very successful and high-quality generic drug substance and medical products. We are glad, that Novartis recognized Slovenia as a partner providing a stable and reliable business environment driven by educated and qualified workers - and as an environment in which to invest, create new business projects and leverage new business opportunities."
With this new field of activity, the ChemOps Mengeš created 20 new jobs. Due to its high-tech nature, manufacture of drug substances for innovative drug products consequently demands a correspondingly high level of educational structure of the employees, who are primarily chemists, chemical technicians and process engineers. The drug substances in the new facility will be manufactured according to Novartis technology, including a minor improvement which is the contribution of Lek’s knowledge. The facility design and approximately 40 percent of the equipment is the result of Slovenian knowledge. The new facility will strengthen the production of high-value drug substances at the Mengeš site and at the same time it represents great potential for exchanging knowledge and experience with Novartis.
As with all Novartis investments, this investment had to meet the high Novartis standards with regard to environmental responsibility and efficiency of energy resource use already at the planning stage. It fully complied with all environmental standards and legal requirements, applicable in Slovenia. All necessary environmental permits, specifying limits of emissions to air and water, waste management, measures to reduce light pollution and methods for safe storage of raw materials and products at the site, were obtained. The production is therefore safe and does not generate any excessive impact on the environment.
Lek, a Sandoz company, is one of the key pillars of the second-largest generic pharmaceutical company globally. Its role within Sandoz is to act as: a leading global development center for technologically demanding products and technologies; a key global manufacturing center for active pharmaceutical ingredients and medicines; a competence center for the development of vertically integrated products; a Sandoz competence center in the field of development and manufacturing of biosimilar active ingredients and products; a supply center for the markets of Central and Eastern Europe (CEE), South East Europe (SEE) and the Commonwealth of Independent States (CIS), and is responsible for marketing and sales of Sandoz products on the Slovenian market. For further information, please visit www.lek.si.
Sandoz, a Novartis company, is a global leader in generic pharmaceuticals and biosimilars, driving sustainable access to high-quality healthcare. Sandoz supplies a broad range of affordable, primarily off-patent products to patients and customers around the globe. The Sandoz portfolio comprises approximately 1,100 molecules, which accounted for 2015 sales of USD 9.2 billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area. The company holds leading global positions in biosimilars as well as in generic anti-infectives, ophthalmics and transplantation medicines.
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2015, the Group achieved net sales of USD 49.4 billion, while R&D throughout the Group amounted to approximately USD 8.9 billion (USD 8.7 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit www.novartis.com.
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 contact:
Lek Pharmaceuticals d. d.
Phone: +386 1 580 22 43
Fax: +386 1 580 24 32