By Andrew Jack
Pfizer could earn $800m after European Union countries extended exclusive rights to sell its most popular drug Lipitor until May next year in exchange for tests that will provide a slightly modified version to a few thousand children.
The US pharmaceuticals group will launch a chewable grape-flavoured low-dose version of its cholesterol-lowering drug Lipitor in the EU in November, when the patents are due to expire, exposing the drug to cut-price generic competition.
But under EU regulations designed to encourage research into medicines for children, Pfizer has sought a ?supplementary protection certificate? in most EU countries, extending its monopoly over supplies and pricing. The action will spark fresh debate about the regulations, which were introduced in 2007.
Pfizer does not give a detailed breakdown of sales for the drug, but figures prepared for the Financial Times by IMS, the healthcare data consultancy, suggest the top five European markets alone account for 14 per cent of Lipitor?s $11bn in annual sales, indicating a six-month extension is worth $770m.
Few expected the system would provide drug companies with returns on the scale to be earned by Pfizer. The additional tests it has carried out have not led to significant changes in the drug?s authorised uses.
Much of Pfizer?s profit in recent years has come from Lipitor, which accounts for about a fifth of total sales, so the expiry of the patents presents the company with a hefty challenge.
Lipitor – or atorvastatin, as it is generically known – is prescribed to adults with high cholesterol, but is also given to children with an inherited condition called familial hyper-cholesterolaemia, thought to affect one in 500 Caucasians.
That suggests a potential pool of a few tens of thousands of European children, of which a very small number have been identified. Data from IMS suggests roughly 20,000 children are prescribed Lipitor in the EU?s largest markets.
Dermot Neely from Heart UK said it was a ?national disgrace? that the UK – which spends ?300m a year on Lipitor – did not try harder to identify children at risk of familial hypercholesterolaemia: ?Pfizer certainly pulled off a bit of a coup. The money the NHS could have saved by the drug going off patent could fund a proper programme.?
Lipitor has gone off patent in Spain, Finland and Norway but remains protected across most of the EU.
Pfizer, which would not comment on the costs of the trials or forecast sales, has won or is seeking extensions in at least 11 markets.
? The Financial Times Limited 2011