Pfizer ($PFE) is poised for a Lipitor reprieve in Europe. The company has asked for 6 months' of additional exclusivity in most EU countries under regulations designed to promote pediatric drug trials. The extension could be worth almost $800 million as it staves off generic competition until May 2012, the Financial Times reports.
Pfizer is in line for the 6-month extension because of studies in children with a genetic disorder that causes high cholesterol. The company plans to launch a chewable, grape-flavored version of Lipitor in November as a result of those trials. "Pfizer certainly pulled off a bit of a coup," Heart UK's Dermot Neely told the FT.
The development is sparking some debate over the European pediatric trials regulations, which were instituted in 2007. But officials and experts say that the pediatric program has resulted in research that wouldn't have been conducted otherwise. "The regulations have been a big advance in developing medicines for children, but throw up some issues which it may be time to revisit," Alasdair Breckenridge, chairman of the UK's Medicines and Healthcare Products Regulatory Agency, told the newspaper.
Although the cholesterol fighter is already facing copycat rivals in some European countries--Spain, Finland and Norway--it's still under patent elsewhere in the EU. Pfizer has won or is seeking 6-month extensions in at least 11 other markets, the FT says, including the U.K., France and Germany.
- read the FT story