Novartis Cell-Based Technology For A(H1N1) Swine Flu Vaccine Production

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First results achieved with A(H1N1) wild type strain shows significant time savings of cell-based production over egg-based manufacturing approach confirming its value in pandemic situations.

Basel, June 12 2009 - Novartis has successfully completed the production of the first batch of influenza A(H1N1) vaccine, weeks ahead of expectations.

Cell-based manufacturing technology[1] allows vaccine production to be initiated once a pandemic virus strain is identified without the need to adapt the virus strain to grow in eggs, as with traditional vaccine technologies. This advance has cut weeks off the time required to begin vaccine production.

This first batch of ten liters of wild type influenza A(H1N1) vaccine monobulk will be used for pre-clinical evaluation and testing and is also being considered for use in clinical trials. It demonstrates the value of the cell-based production approach, that is also being used by Novartis with reassortant influenza A(H1N1) seed.

The Novartis state of the art cell-culture vaccine production facility is located in Marburg, Germany. As well as speed, another advantage of cell-based production is the ability to rapidly increase production, so the facility has the potential to produce millions of doses of vaccine each week. A second facility, in collaboration with the US Department of Health and Human Services, is under construction in Holly Springs, North Carolina[1].

"The speed advantages of our cell-based production approach and our unwavering commitment to address this public health emergency have resulted in our ability to provide the fastest possible response to this outbreak," said Dr. Andrin Oswald, CEO of Novartis Vaccines and Diagnostics. "This achievement is also a testament to the technical skills and innovation of Novartis Vaccines and Diagnostics people and our partners. I believe it highlights our reputation as a leader in influenza vaccine research, development and production."

Based on this success with the wild type, Novartis expects to be able to achieve rapid scale up of influenza A(H1N1) vaccine manufacture with reassortant seed which was provided by the Centers for Disease Control and Prevention (CDC) on May 27th. The company plans to start clinical trials with that vaccine in July and expects licensure in the fall of 2009.

More than thirty supply requests received from Governments

More than 30 governments have made requests to Novartis to supply them with influenza A(H1N1) vaccine ingredients. These are a combination of pre-existing pandemic vaccine supply agreements and new requests for vaccines across all our production platforms including egg-based manufacturing. The US Department of Health and Human Service's $289 million order in May 2009[1] with Novartis was the largest of the US government's commitments to influenza A(H1N1) vaccine ingredients. That order included Novartis proprietary adjuvant MF59®, which can be added to influenza vaccines to help stimulate the human body's immune response to the vaccine. Data published in April 2009 in the Proceedings of the National Academy of Sciences of the United States of America reinforced the potentially broad applicability of MF59. MF59 is the only influenza adjuvant with an established safety profile which is supported by more than ten years of clinical safety data in Europe, and more than 40 million doses of commercial use in the influenza vaccine Fluad®. Fluad is licensed in Europe but not the US.

The Novartis pandemic vaccine developmental program began in 1997 under the leadership of Dr. Rino Rappuoli who is Head of Research at Novartis Vaccines.

Footnote

[1] Development of Novartis' cell-based influenza vaccine, construction of the cell-based influenza manufacturing facility at Holly Springs, NC and purchase of H1N1 antigen and adjuvant are being funded in whole or in part with Federal funds from the Office of Public Health Emergency Preparedness, Office of Research and Development Coordination, under Contract Numbers HHSO100200600012C, HHSO100200900101C and HHSO100200800072I, respectively.

Source: Novartis