Novartis invests in early technical development capabilities for next-generation biotherapeutics, also with an investment in Slovenia

  • Multi-year investment of USD 300m will create integrated scientific environment to deliver on increasing growth and diversity of biotherapeutics portfolio
  • Enhanced capacity and processes expected to lead to faster transition times from pre-clinical to first-in-human studies
  • Commitment to early phase biologics development in Switzerland, Slovenia & Austria. With an investment of USD 110m in clinical manufacturing and technical development capabilities we will create a BioCampus in Mengeš.  
12. 9. 2022

Novartis today announced it is investing in next-generation biotherapeutics with the creation of a fully integrated, dedicated USD 300m scientific environment that will bolster its capacity and capabilities for early technical development of biologics. Spanning both drug substance and drug product development, the multi-year investment will be implemented across existing Novartis locations in Switzerland, Slovenia and Austria, strengthening Novartis ability to deliver on the increasing growth and diversity of its early-stage biotherapeutics portfolio.

“Across the industry, biotherapeutics account for almost one-half of all recent new drug approvals and have enormous potential to address unmet need across a wide range of diseases,” said Reto Fischer, Head of Technical Research Division, Global Drug Development (GDD), Novartis. “We are building the scientific environment necessary to bring these complex biologic compounds from the bench through development in an integrated, seamless, and rapid fashion. In doing so, we are supporting our broader ambition to enable faster development and focused prioritization across our global portfolio.”

Mengeš site has a long tradition in biologics development in Slovenia, dating back to the 1980s. Today, Mengeš is the largest development center for modern biotechnology in Slovenia with around 360 associates and strong collaboration with Slovenian academic and research institutions. “With the new investment, we will strengthen our position in the field of biologics development externally and within Novartis. The new BioCampus will enable new development capacities, including clinical manufacturing to support early clinical studies. We are looking forward to build upon our knowledge and experience, enable development of new expertise and attract new talents to this exciting story we have been building in Mengeš for a few decades now,” said Špela Jalen, Site Head Biologics TRD Mengeš.

The Novartis early-stage biologics portfolio has grown significantly in the last 15 years. It has also expanded beyond conventional monoclonal antibodies into a wide range of novel development candidates with potential to be first-in-class, best-in-class, or both, including antibody-drug conjugates and therapeutic proteins.

This  investment is intended to position Novartis at the forefront of biotherapeutic development, by supporting the company’s increasingly sophisticated pipeline  with the most advanced technical infrastructure, alongside the highest level of  capabilities. It will create seamless, end-to-end development and manufacturing  environments by embedding biologics development within existing Novartis  commercial manufacturing facilities in Slovenia and Austria as well as by  establishing a biologic’s hub on the Basel St. Johann Campus in Switzerland  alongside the NIBR biologics center fostering scientific innovation, technology leadership and talent attraction. Collectively these commitments will enhance  development processes targeting faster transition times from pre-clinical to  first in human studies. 

Specifically, the investment will:

  • Strengthen the Novartis St. Johann campus in Basel by investing USD 100M USD to establish a biologics hub to complement the existing NIBR Biologics Center;
  • Create a biocampus in Mengeš, Slovenia with an investment of USD 110M USD in clinical manufacturing capabilities (non cGMP and cGMP) and technical development capabilities in proximity of development operations; and
  • Amplify synergies and strategic proximity at the Schaftenau campus in Austria with a USD 60M USD investment in development manufacturing capacity and capabilities.

“The science of developing biologics is increasingly sophisticated, and we are excited to meet its challenges head-on,” said Jonathan Novak, Global Head for Biologics, Technical Research Division, GDD at Novartis. “We look forward to amplifying the knowledge and experience of our associates to ensure that biologics development is an exhilarating and rewarding process for our current and future colleagues – and that is ultimately a source of profoundly innovative new therapies for patients worldwide.” 

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Novartis is the leading provider of medicines in Slovenia, where Lek d.d.,Novartis Pharma Services Inc. and Sandoz d.d., 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 inNovartis' organizational structure, especially in the Novartis TechnicalOperations, 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 3 billion since 2003.

About Sandoz
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2021 sales of USD 9.6 billion.

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 product sreach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140nationalities work at Novartis around the world.
  Find out more at www.novartis.com.

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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.

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For additional information contact:
Gregor  Makuc
Communications & External Engagement
Lek Pharmaceuticals d. d.
Phone: +386 1 580 22 43
gregor.makuc@sandoz.com