Bird Flu: Science and Policy

[DewDiligence]

CHMP Approves NVS ‘Mock-Up’ Bird-Flu Vaccine

http://online.wsj.com

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By Anita Greil
02-23-07 0933ET

ZURICH (Dow Jones)--The European Union health regulator Friday recommended approval of a mock-up vaccine for the treatment of pandemic flu by Swiss drugmaker Novartis AG (NVS).

The Committee for Medicinal Products for Human Use is recommending to grant marketing authorization for Focetria, which is intended for the prevention of influenza during an officially declared pandemic situation, once the pandemic viral strain has been included in the vaccine.

It's the second time the agency is endorsing such a vaccine, having already recommended GlaxoSmithKline Plc's (GSK) product Daronrix in December.

…A mock-up application allows vaccine manufacturers to go through many of the stages of regulatory approval on the basis of one virus strain. Once the actual pandemic strain is identified, drug companies then simply replace the mock-up strain without having to go through the entire regulatory process from scratch.

"The availability of a pandemic influenza vaccine soon after the declaration of a pandemic is essential to reduce disease burden and deaths," said Joerg Reinhardt, chief executive of the company's vaccines and diagnostics, a division of Novartis.

Focetria would contain the pandemic influenza strain declared at the time of a pandemic along with the proprietary adjuvant MF59 developed by Novartis. Studies have shown that this adjuvant boosts the body's immune response to the vaccine's active ingredient. It can also extend vaccine supplies by allowing for smaller amounts of viral antigens to be used in each dose compared to vaccines without this additive.

…Novartis bought into the vaccine business last year by acquiring Chiron Corp. and has since made it a key pillar of its strategy, which also includes significant operations in prescription medicines and generics.

Novartis and GlaxoSmithKline have also developed a new vaccine manufacturing process that uses cell cultures rather than chicken eggs to produce antigens. The new technology is expected to reduce production time to meet demands of influenza outbreaks and to combat evolving strains of the virus, including avian influenza strains that are difficult to grow in eggs.

Novartis' cell culture-based vaccine Optaflu was submitted for E.U. regulatory approval in July 2006 and is currently in clinical studies in the United States.
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