The pharmaceutical company Pfizer has been given a six month extension on the patent for the high cholesterol medication Lipitor, with estimates suggesting this could be worth $770m to the company.
The extension was granted by the European Commission because Pfizer has developed a paediatric version of the medication, a chewable, grape-flavoured form designed for children with high cholesterol who are over the age of ten. It is also now recommended for children who have familial hypercholesterolemia, an inherited disorder that causes high triglycerides.
The six month extension will mean that Pfizer will maintain exclusivity over this form of high cholesterol medication until May 2012. Lipitor is Pfizer’s bestselling medication, and figures quoted in the Financial Times suggest that the extension could bring in an additional $770m, based on the fact that the European share of the annual sales of Lipitor amounts to 14% of $11 billion. The extension only applies to some EU countries.
The granting of the extension by the European Commission is part of a movement to incentivise pharmaceutical corporations to focus on clinical trials that include children. The new paediatric regulations in the EU were launched in 2007 to some controversy. Though the regulations have meant that there have been developments in medications for children, it allows companies like Pfizer to significantly profit from the new guidelines.
The chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, Professor Sir Alisdair Breckenridge spoke to the Financial Times, pointing out that “[t]he regulations have been a big advance in developing medicines for children”. He, does contend, however, that they also “throw up some issues which it may be time to revisit”.