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 user 2006-07-26 at 11:11:00 am Views: 60
  • #16085

    Glaxo has bird flu ‘breakthrough’
    drugs firm GlaxoSmithKline believes it has developed a vaccine for the
    H5N1 deadly strain of bird flu that may be capable of being mass
    produced by 2007.

    vaccine has proved effective at two doses of 3.8 micrograms during
    clinical trials in Belgium, BBC business editor Robert Peston has
    It is the size of the dose that is highly significant,
    Glaxo explained.Firms want the smallest effective dose so that they can
    get the maximum number of shots out of a quantity of vaccine.Glaxo has
    yet to publish the results of its tests.The news of the work on a
    potential vaccine came as Glaxo reported its profits had risen 14% in
    the three months to June to £1.32bn (US$2.4bn).

    said that governments could order the vaccine for delivery and
    stockpiling in early 2007.One of Glaxo’s main rivals, the French drug
    company Sanofi Aventis, has also been working on a vaccine.A study
    published in the Lancet in May showed that Sanofi’s vaccine had some
    effectiveness in some patients who were treated with two 7.5 microgram
    doses.In February, the NHS awarded a contract to another firm – Baxter
    International – for two million doses of its H5N1 vaccine to inoculate
    “key” public service workers.

    Government talks
    companies are looking to develop treatmentsbecause of concerns that the
    H5N1 virus will combine with a human flu virus and mutate into a form
    which can spread between humans.Since 2003 there have been 231 cases of
    bird flu in humans, resulting in 133 deaths.A pandemic flu strain
    spreading between humans has yet to emerge. Since no one knows what
    such a strain would look like, companies cannot yet develop a targeted
    vaccine.But a number of firms, including Glaxo, are seeking to develop
    vaccines based on the existing H5N1 strains in order to give humans
    some form of protection.Glaxo says it will now start discussing with
    governments about whether they want the vaccine and how much they may
    want to order.Its vaccine, like others in development, is on a fast
    track for approval with the relevant licensing authorities in the US
    and Europe – the US Food and Drug Administration (FDA) and the European
    Medicines Evaluation Agency (EMEA).”All being well, we expect to make
    regulatory filings for the vaccine in the coming months,” said Glaxo
    chief executive Jean-Pierre Garnier.

    Prime desire
    seems highly confident that demand for itsvaccine will be huge, the
    BBC’s business editor said.The UK and US have both indicated a desire
    to “prime” their respective populations with an initial inoculation.Mr
    Garnier said he recently met US President George W Bush to discuss the
    vaccination programme.Following that meeting, Glaxo received $272m
    (£148m) of funding, earmarked in part for the development of new
    technologies to produce vaccines.Glaxo said its new vaccine would give
    limited immunity to bird flu in the event of a pandemic. A second shot
    would be necessary for complete immunisation, the company said.If there
    were a pandemic outbreak in the early autumn, mass manufacture of
    Glaxo’s vaccine could probably be started quickly through collaboration
    with rival pharmaceutical companies.Glaxo said it was also talking to
    the Gates Foundation about how to provide the vaccine to poorer,
    developing countries.

    Shotgun effect
    the company’s optimism, there were a number of unanswered questions,
    the BBC’s business editor said.Firstly, there is uncertainty over how
    many doses can be manufactured quickly, and how easy it would be to
    make the transition from laboratory testing to mass production.And
    secondly, it is not clear how effective the vaccination would be if
    H5N1 were to mutate significantly.Glaxo says its vaccine is more akin
    to shotgun treatment than a “precision-rifle cure”, which means that it
    appears to be effective against small mutations in the virus
    strain.However, it has yet to determine the effectiveness of the
    vaccine against big changes in the H5N1 strain.Glaxo said the cost of
    the vaccine is likely to be a little more than for conventional flu
    vaccines, which retail for about £4 per shot.According to Glaxo, the
    side effects or reactions to its bird flu vaccine have been very
    similar to those generated by a conventional influenza treatment, and
    have been limited to a fever in a number of patients.Drug companies
    including Glaxo have been looking to expand their vaccination
    programmes as fears rise about an outbreak of a viral pandemic and
    governments come under increased pressure to protect their
    populations.Glaxo bought Canadian vaccine company, ID Biomed, for $2bn
    last autumn and is now probably the second-largest manufacturer of flu
    vaccines after Sanofi.