Novartis, Baxter in race for H1N1 flu vaccine

ZURICH Fri Jun 12, 2009 4:45pm EDT

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ZURICH (Reuters) - Novartis AG expects a vaccine for the H1N1 virus, the source of the first flu pandemic for 40 years, to be available by the autumn after it produced the first batch for testing ahead of schedule.

Meanwhile, U.S. company Baxter International Inc said it is in full-scale production of an A/H1N1 flu pandemic vaccine that could be ready for commercial use as early as next month.

The Baxter and Novartis vaccines were both developed using cell-based technology that could allow for much more rapid production and distribution than traditional vaccines produced using chicken eggs.

The Novartis vaccine will enter clinical trials next month, the Swiss drugmaker said on Friday, a day after the World Health Organization declared a pandemic and warned governments to prepare for a long battle against the virus.

Baxter said it had completed testing and evaluation of the virus and would submit its A/H1N1 vaccine for approval upon completion of initial manufacturing runs.

European drugmakers Novartis, Sanofi-Aventis, GlaxoSmithKline and Solvay all obtained the influenza A (H1N1) seed virus in recent weeks and aim to have a vaccine ready ahead of the northern hemisphere flu season.

The WHO has estimated vaccine makers could produce up to 4.9 billion pandemic flu shots a year in a best-case scenario, leaving some of the world's 6.5 billion population unprotected, particularly if more than one injection was needed to gain immunity.

Novartis said first results with the H1N1 wild type strain showed it was quicker to make the vaccine through cell-based rather than through egg-based production, and it had completed its first batch weeks earlier than expected.

Its cell-culture vaccine plant in Marburg, Germany had the potential to produce millions of doses per week, but it was difficult to predict output capacity for now.

Spokesman Eric Althoff said Novartis should have the vaccine ready in September or October. He was unsure if other companies had completed the first stage of the production process.

Glaxo said Friday it would be able to meet advance purchase commitments for 150 to 180 million doses, and the 50 million it donated to the WHO for developing countries.

Wayne Pisano, head of vaccines at Sanofi, the world's largest flu vaccine supplier, said on Thursday his company would "produce the largest number of doses of vaccine in the shortest time frame," though it would be another four months before the first supply of bulk concentrate was ready.

Novartis shares closed up 4.4 percent, while Baxter shares were up 3.5 percent.

CELL-BASED TECHNOLOGY

The H1N1 strain has spread widely, with 28,774 infections confirmed in 74 countries to date, including 144 deaths, according to the WHO's latest tally. Although the strain seems mild at present, health officials are worried it might return in a more virulent form in the northern hemisphere winter.

While commercial production of vaccines usually depends on how easily a virus strain grows in chicken eggs, Novartis said its cell-based technology means it can produce a vaccine without having to adapt the virus strain to grow in eggs.

"The cell-based manufacturing puts Novartis at the forefront of supplying pandemic vaccines to governments around the world," said Helvea analyst Karl-Heinz Koch.

A number of national public health authorities have agreements with Baxter that allow them to place orders for its vaccine now that a pandemic has been declared by WHO, Baxter said.

Novartis said more than 30 governments have made requests for vaccine ingredients, combining preexisting pandemic vaccine supply agreements and new requests for vaccines across all production platforms.

The H1N1 flu outbreak is the first to be declared a pandemic since 1968, and WHO Director-General Margaret Chan said on Thursday different regulatory authorities needed to work together to speed registration of a safe vaccine.

The question of how the vaccine would be dispensed was still open, Novartis' Althoff said.

"This will depend on government programs and what health authorities, the WHO and others say on how they want to make it available," he said.

(Reporting by Katie Reid; Additional reporting by Bill Berkrot in New York, Sam Cage in Zurich and Ben Deighton in London; Editing by Jon Loades-Carter, John Stonestreet; Editing by Gary Hill)

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