Development center Slovenia associates receive the highest annual Sandoz Award
- Sandoz Award for outstanding achievements in 2018 in the category Operational Excellence went to the Development center Slovenia Team. In cooperation with a US team, they were the first and only in the industry to submit a registration file with the US Food and Drug Administration (FDA) for extended release capsules with amantadine, designed for the treatment of dyskinesia in patients with Parkinson's disease.
- With this achievement, Sandoz has acquired for the first time in history the so called »exclusive first-to-file« status, including the 180-day exclusivity for a generic product in the US market, which is an impressive accomplishment.
- The Development center Slovenia with its highly qualified development teams is the largest and the best-equipped center of its kind within Sandoz, the generic part of Novartis that develops and launches a number of new products to global markets.
The project leader Lidija Vraničar Savanovič, PhD from the Development Center Slovenia, received the Sandoz Award for outstanding achievements in 2018 in Athens on behalf of the development team. »Working on this project was an unforgettable experience. Our success confirms the high level of professionalism, dedication, perseverance and the ability of Slovenian development teams to collaborate with others across the company. I am very proud of what we are able to do and can do!«, she stressed.
The development Center Slovenia develops annually on average 21 new medicines with a new drug substance, new dosage form or for a new market. In 2018, they completed the development and filed 20 drug product dossiers in the markets of the US, Russia, Europe, Canada, Thailand and China as well as one dossier for a drug substance in the USA and another in Canada. They completed the development of the high-quality innovative dietary supplement LincomplexTM, which is already available to Slovenian users.
It is the largest and best-equipped center of its kind within Sandoz, and it is becoming increasingly visible also within the Novartis development network as a partner for services supporting the development of innovative and biological medicines.
In response to a rapidly changing political, economic and demographic situation, opportunities in the external environment and patent expiry of some of its higher volume products, Novartis will focus in the future on small volume specialised and personalised medicines. Focusing on biosimilars and complex differentiated generics concurs with the great efforts to successfully build a pipeline of value added medicines that will offer significant additional benefits for patients and help strengthen sustainability and viability of healthcare systems around the world.
Therefore, Novartis is investing in new technologies that will support these products while at the same time optimising its manufacturing network and adapting the capacities of its production sites and equipment where under-utilised. It is on its journey to transform into the leading pharmaceutical company, powered by data and digital.
Novartis is the leading provider of medicines in Slovenia, where Lek, Novartis Pharma Services and Sandoz, operate. Together we are building and maintaining the reputation of a dynamic, ethical, and trusted pharmaceutical company. Lek develops, manufactures, and markets effective, safe, and high quality medicines and active pharmaceutical ingredients. With our knowledge, quality, and experience we have gained an important role in Novartis' organizational structure, especially in the Novartis Technical Operations, Global Drug Development, Novartis Business Services, and the generic division Sandoz. We are the leading Sandoz development center, and one of the key development sites for technologically complex projects. We invest a great deal in the development, education, and training of our employees. Novartis invested in Slovenia more than EUR 2 billion since 2003. More than half of this investment has been devoted to development, and the rest to modernize and expand our production capacities.
About Sandoz
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars and a pioneer in the emerging field of prescription digital therapeutics. Our purpose is to pioneer access to healthcare by developing and commercializing novel, affordable approaches that address unmet medical need. Our broad portfolio of high-quality medicines, covering all major therapeutic areas and increasingly focused on value-adding differentiated medicines, accounted for 2018 sales of USD 9.9 billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.
About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach more than 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 130 000 people of nearly 150 nationalities work at Novartis around the world. Find out more at 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:
Katarina Klemenc
Corporate Communications
Lek Pharmaceuticals d. d.
Phone: +386 1 580 22 43
Fax: +386 1 580 24 32
katarina.klemenc@sandoz.com
