NOVARTIS' PANDEMIC FLU VACCINE RECOMMENDED FOR APPROVAL IN EUROPE

Novartis announced today it has received a positive opinion supporting European regulatory approval of its Focetria pandemic influenza vaccine.

The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use has recommended approval of this vaccine. The European Commission generally follows the committee's recommendations and delivers its final decision within two to three months, according to Novartis.

Novartis' application for Focetria was considered a mock-up since it lays the groundwork for a more rapid approval and availability. Once the World Health Organization declares a pandemic, Novartis will submit a revised application to the EMEA to incorporate the identified viral strain.

Focetria would be manufactured to contain the pandemic influenza strain, along with the proprietary MF59 adjuvant developed by Novartis. Studies have shown that MF59 could boost the body's immune response and extend vaccine supplies by allowing for smaller amounts of viral antigens to be used in each dose compared with vaccines without this additive.

Novartis submitted the Focetria mock-up application in early 2006. The company also submitted an application for an MF59-adjuvanted H5N1 prepandemic influenza vaccine based on the same technology as Focetria.

The EMEA also adopted a positive opinion of GlaxoSmithKline's Daronrix mock-up pandemic flu vaccine in December 2006.