News

Posted On: 07/18/2006

Novartis Plans Vaccine Plant in N.C. to Support Pandemic Preparedness

PharmaManufacturing.com

Novartis on July 18 announced plans to build the first cell culture-derived influenza vaccines manufacturing plant in the United States at a site in Holly Springs, N.C., with construction expected to begin in 2007.

The Basel, Switzerland-based company also reported the first European Union submission of a cell culture-derived influenza vaccine, also commonly referred to as "flu cell culture influenza vaccines." The submission to the Committee for Medicinal Products for Human Use (CHMP) was made in June after the successful completion of Phase III clinical studies. Novartis is also making additional investments in its Marburg, Germany, site to expand capacity for flu cell culture vaccines production in Europe.

After completion, Novartis' Holly Springs, N.C. plant will be able to produce about 50 million doses of flu vaccines annually, with the "as needed" flexibility to boost output to 150 million doses.

Novartis is seeking to become the first to commercially produce and market flu cell culture vaccines for European markets. U.S. clinical studies, which began in 2005, are ongoing. The vaccines for the EU and U.S. clinical trials have been produced at the Novartis site in Marburg, where the product was developed.

"We are taking the lead in moving flu cell culture vaccine manufacturing closer to a commercial reality now that the site for a U.S. manufacturing plant has been chosen and the first EU submission for a flu cell culture vaccine has been completed," said Dr. Daniel Vasella, Novartis chairman and CEO. "Novartis is pioneering this innovative vaccine technology to bring reliability and flexibility of the manufacturing process to a next level . . . to meet the growing need for seasonal influenza vaccines and quickly respond to a potential pandemic influenza threat once the factory has been completed."

A total investment of approximately $600 million, which includes a recent $220 million award from the U.S. Department of Health and Human Services, is planned to build and equip the Holly Springs site.

Once the Holly Springs site is completed and approved for commercial production, Novartis expects it to produce up to 50 million doses of seasonal trivalent flu vaccines each year, which will be for use in the U.S. In the event of an influenza pandemic, the site is designed with the flexibility to ramp up to production of 150 million monovalent doses annually within six months of a pandemic declaration.

New flu cell culture vaccine manufacturing technology promises many advantages over traditional egg-based production, including greater reliability and a reduction in production lead-time. These advantages could be pivotal in the event of an influenza pandemic. As flu cell culture vaccines move toward commercialization, egg-based influenza vaccine production is expected to continue playing a critical role in reducing the impact of influenza outbreaks and prepare for a potential influenza pandemic.

About the Novartis Vaccines influenza vaccines pipeline

Cell culture-derived influenza vaccines use modern biotechnology cell cultures rather than chicken eggs for primary production. Current egg-based influenza vaccines production requires several months of logistics for ordering and receiving eggs.

This lead time can hinder the response to unanticipated demands such as the discovery of pandemic strains, production failures and seasonal influenza virus strain changes. In contrast, flu cell culture production enables flexible, faster start-up of vaccine manufacturing, and does not depend upon the availability of eggs, providing a particularly important advantage in the event of an influenza pandemic.

For more information, see www.novartis.com.