June 12, 2009 / 12:05 PM / 9 years ago

Novartis hopeful of H1N1 flu vaccine by autumn

* Makes 1st batch of vaccine faster than expected

* Pandemic declared; more than 30 govts asked for vaccine

* Swiss drugmaker to start clinical trials in July

* Shares up 4 pct, other vaccine makers also gain

(Adds GSK comment, analyst, updates shares)

By Katie Reid

ZURICH, June 12 (Reuters) - Novartis AG NOVN.VX 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.

The vaccine will enter clinical trials next month, the Swiss drugmaker said on Friday, a day after the World Health Organisation declared a pandemic and warned governments to prepare for a long battle against the virus. [ID:nNLB765857]

Novartis, Sanofi-Aventis (SASY.PA), GlaxoSmithKline (GSK.L) and Solvay (SOLB.BR) 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. [ID:nLB16505]

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 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 on 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. [ID:nLF949487]

"We don’t see any upside in this race to have the first vial off the production line. For us its about focusing on producing significant volumes of the pandemic vaccine to ensure that countries and their populations are protected," a Glaxo spokesman said.

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 timeframe", though it would be another four months before the first supply of bulk concentrate was ready.

By 1138 GMT, shares in Novartis had risen 4 percent to 44.84 Swiss francs, while the European pharmaceuticals sector was trading 2.3 percent higher .SXDP. Glaxo, Sanofi and Solvay shares rose between 1.3 and 3.7 percent.


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.

H1N1 vaccines are tested first on ferrets and then on humans in clinical trials before regulatory approval is granted.

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

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. [ID:nWLA6459]

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

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

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

(Additional reporting by Sam Cage in Zurich and Ben Deighton in London; Editing by Jon Loades-Carter, John Stonestreet)

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