British drugs company renegotiates H1N1 deals with 'many governments'

The British pharmaceuticals giant GlaxoSmithKline has confirmed it is in talks with several countries keen to reduce their orders of its swine flu vaccine Pandemrix. The Belgian government yesterday became the latest to tell the company that it was paring back its requirement.

The health ministry in Brussels said it would be cutting its order by about โ‚ฌ33m (ยฃ29m) after initially asking for 12.6 million doses of Pandemrix. The cancellation comes after a host of countries in the northern hemisphere told the pharmaceuticals industry that there was insufficient demand for the treatment. Britain, France, Germany, Spain and the US have all indicated in the past two weeks that they will be renegotiating their deals.

Demand for vaccines to combat H1N1 influenza has fizzled out because the pandemic has proven to be less aggressive than was first feared. Regulators who initially indicated that two vaccinations would be needed by each swine flu patient now say that one dose is sufficient. Analysts predict that European governments could return or cancel up to 50 per cent of what they ordered, which could reduce GSK's income from Pandemrix by ยฃ300m.

Andrew Witty, the chief executive of GSK, said in October that forecasts for about ยฃ1bn in sales of Pandemrix in the fourth quarter were "pretty close to being right". However, since he made his remarks a number of analysts have lowered the estimates. Credit Suisse, for example, cut its forecasts for GSK's 2009 and 2010 sales by $800m.

GSK issued a statement yesterday, saying it shipped 130 million doses of Pandemrix, worth ยฃ835m, in the final three months of last year. "Shipments of the vaccine continue to be delivered in the first half of 2010 and GSK is in ongoing discussions with many governments as their needs evolve," the company added. "This includes renegotiation of contracts with governments who have announced changes to their planned immunisation programmes, and with governments who have placed new orders for the pandemic vaccine. It is therefore too early to say what the final number of doses supplied and the value of these orders will be."

GSK pointed out that while sales in the northern hemisphere would be hit, countries in the southern hemisphere had yet to reach peak swine flu season. Drugs that were originally earmarked for countries such as Britain and Germany this winter could be re-routed elsewhere in the coming months.

Yet this could still be costly for GSK. Countries south of the equator are generally thought to be paying less for the vaccine. The company has disclosed that it charges clients on a sliding scale, from โ‚ฌ7 a dose for developed countries, to providing the World Health Organisation with 60 million vaccines for free.

Earlier this week, GSK confirmed that German health officials had cancelled 30 per cent of its Pandemrix order, trimming it to 34 million doses. Meanwhile, the French health minister, Roselyne Bachelot, told French television last week: "I have cancelled 50 million doses. These orders had not been paid for or delivered so they are cancelled."

GSK insists that talks with France are ongoing. Ms Bachelot's ministry originally said it would need 94 million vaccines and ordered them from GSK, Sanofi-Pasteur, Baxter and Novartis. Baxter, along with GSK, has a contract to supply swine flu vaccine in the UK.

News of more cancelled vaccine orders came as the WHO hit back at claims that its H1N1 forecasts had been unduly influenced by the big drugs companies. Keiji Fukuda, the WHO director-general's special adviser on pandemic influenza, said yesterday: "The world is going through a real pandemic ... the description of it as a fake is both wrong and irresponsible".

His comments followed a claim by Wolfgang Wodarg, the chairman of the Council of Europe's health committee, that global drugs companies had influenced the WHO's assessment of the dangers of the H1N1 virus, calling the outbreak a "false pandemic"

Mr Wodarg said the WHO's campaign was "one of the greatest medicine scandals of the century".

GSK also issued a robust rebuttal of Mr Wodarg's comments yesterday, saying: "Allegations of undue influence are misguided and unfounded. The WHO declared that H1N1 swine flu met the criteria for a pandemic.

"Responding to it has required unprecedented collaboration. As WHO have stated, legal regulations and numerous safeguards are in place to manage possible conflicts of interest."