Novartis plans to begin building the first cell culture-derived influenza vaccines manufacturing plant in the U.S. in 2007. The Swiss company intends to invest $600 mil. in the project, including a $220 mil. award from the Department of Health & Human Services.

Novartis announced plans July 18 to construct the manufacturing plant in Holly Springs, N.C.

"We are taking the lead in moving flu cell culture vaccine manufacturing closer to a commercial reality now that the site for the U.S. manufacturing plant has been chosen," Novartis said.

Once construction is completed and approved by FDA, Novartis expects to produce on site 50 mil. doses of seasonal trivalent flu vaccines, which will be dedicated to the U.S. market. However, the manufacturing center will have the capacity to produce up to 150 mil. monovalent doses annually within six months in the event of an influenza pandemic.

Manufacturers and regulators hope that cell culture technology will allow for cheaper, more rapid production of vaccines.

Novartis is currently evaluating flu cell culture vaccines through clinical trials in the U.S. market. The company also took a step closer to becoming the first to market flu cell culture vaccines for the European market, announcing July 18 that it had submitted a marketing authorization application to the European Medicines Agency.

Vaccines for the corresponding Phase III trials were produced at Novartis' site in Marburg, Germany, where the company is bolstering capacity.

Novartis entered the flu vaccine market earlier this year with the acquisition of U.K.-based Chiron, the maker of Fluvirin (¹ Also see "Novartis Cements Chiron Buy With Increased Bid" - Pink Sheet, 3 April, 2006.).

At the time, management said it would increase investment in cell-based flu vaccine manufacturing.

-Jessica Merrill

Novartis Will Spend $600 Mil. On Cell Culture-Derived Influenza Vaccine Facility

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