Sustainability Report 2014 Lek d.d.

15 Profil druÏbe Company Profil 1.3.3.2 Menge‰ site The Menge‰ site comprises Active Pharmaceutical Ingredi- ents (API) Menge‰, Biopharmaceuticals, Development of Pharmaceutical Ingredients, a part of Production of Solid Dosage Forms and development of Anti-infectives. The de- velopment and production of the active pharmaceutical ingredients at this site have been carried out since 1946. Its growth was driven by the expansion of the active pharma- ceutical ingredient pipeline, both in processes of biosynthesis as well as organic synthesis. Since year 2000 it has witnessed a rapid ongoing development of biopharmaceuticals. More than 20 active ingredients are included in the production program. In 2014, the API production volume and utilization of production capacities again grew by 15%. Increased growth of the existing production program and the introduc- tion of new active ingredients was recorded, primarily for Novartis. The share of Novartis products in the entire Menge‰ product pipeline is increasing and accounts for almost a quarter of production output. In 2014, Biopharmaceuticals Menge‰ fully realized all key development and production targets. The development part was enhanced by establishing the area Development of Pharmaceutical Products. Our production plant for recom- binant technology (PORT) again produced record quantities of erythropoietin which is used for the treatment of anaemia, primarily in kidney patients and cancer patients. At the mod- ified protein manufacturing facility (POMP), a production of pegylated filgrastim which is used for the management of chemotherapy- and bone marrow transplantation-induced neutropenia (low white blood cell count) is carried out. In June, new laboratories for Quality Control Bioanalytics were opened, in which the testing of biological activity for all Sandoz biosimilars will be performed. The new laborato- ries are an important addition to the site as they will support the release of products on the market for the entire Sandoz Biopharmaceuticals. Furthermore, new investments confirm that we are one of the key centers of Sandoz Biopharma- ceuticals. In November we started the construction of a new facility with laboratories for protein analysis, development of finished biopharmaceutical forms and biophysics of proteins. We successfully passed the JAZMP audit and extended the GMP certificate for the next three years. Egidij Capuder, site Head API production, Menge‰ MatjaÏ Oven, Head Biopharmaceuticals Construction of a new production plant in Menge‰ "In order to meet all the market needs for active ingre- dients, we decided to build a new production plant in Menge‰. The investment activities were very intense in 2014 and start-up of the new API production is planned for mid-2015. The rapid progress of this project is a result of the good cooperation between all stakeholders. Construc- tion and installation works will be followed by complex technological equipment and all support system qualification processes." Ambitious targets "In 2014, we strengthened our Biopharmaceuticals team with many new colleagues and are passion- ately pursuing ambitious targets that the unit has set. Together we contribute towards building a strong and sustainable quality culture and live our common mission."