Novartis (Basel, Switzerland) reported that German regulatory authorities approved its adjuvanted cell culture-based Influenza A (H1N1) 2009 monovalent vaccine, Celtura. The company is continuing to pursue registration in other major countries, including Japan and Switzerland.

Celtura is manufactured in Marburg, Germany, and is an MF59 adjuvanted inactivated influenza virus vaccine indicated for active immunization of persons six months of age and older against influenza disease caused by the novel pandemic H1N1 virus. The vaccine contains 3.75 micrograms of antigen and 0.125 mL of MF59. It will be offered in multidose vials and in single-dose prefilled syringes.

Celtura uses a validated cell-culture line for production of viral antigen components rather than traditional chicken eggs. The technology has previously been licensed in Europe for the production of the seasonal flu vaccine, Optaflu.

“We quickly ramped up capacity at our licensed cell-culture facility in Marburg, Germany, to respond to the need for a pandemic vaccine,” said Andrin Oswald, CEO of Novartis Vaccines and Diagnostics, in a company release. “Also, we are close to completion of a second cell culture-based influenza vaccine manufacturing site in the US, which is being built in partnership with the US Department of Health and Human Services (HHS)."

Novartis reported on Nov. 3, 2009, that it had begun delivery of the company's egg-based pandemic vaccines, Fluvirin A (H1N1) monovalent vaccine to the US, and Focetria A (H1N1) monovalent vaccine to countries around the world. FDA approved the Fluvirin A (H1N1) vaccine on Sept. 15, 2009, and the European Medicines Agency approved the Focetria A (H1N1) vaccine on Sept. 29, 2009.

Building a vaccine presence in China
In other news, Novartis reported that it has agreed to acquire a 85% stake in the Chinese vaccines company Zhejiang Tianyuan Bio-Pharmaceutical as part of a “strategic initiative to build a vaccines industry leader in this country and expand the Group's limited presence in this fast-growing market segment,” according to a Novartis release. The proposed RMB-850 million ($125-million) acquisition will require government and regulatory approvals in China.

Tianyuan is a privately owned vaccine company offering a range of marketed vaccine products in China and research and development projects focused on various preventable viral and bacterial diseases. Tianyuan had 2008 sales of approximately $25 million. The company employs roughly 400 people and has a research and development and manufacturing site in Hangzhou, Zhejiang Province, near Shanghai.