Sep 12, 2022
  • 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

Basel, Sept 12, 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.”

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 to establish a biologics hub to complement the existing NIBR Biologics Center; 

  • Create a biocampus in Mengeš, Slovenia with an investment of USD 110M 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.”

Disclaimer
This media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this media update, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.

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 nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

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