*NEWS*BIRD FLU BREAKTROUGH ……

[Anonymous]

Glaxo has bird flu ‘breakthrough’
UK 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.
The vaccine has proved effective at two doses of 3.8 micrograms during clinical trials in Belgium, BBC business editor Robert Peston has learned.
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).

Delivery
Glaxo 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
Drug 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
Glaxo 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
Despite 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. 

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July 26, 2006 at 11:09 AM