Pfizer’s cholesterol drug Lipitor (atorvastatin) earns the company around $11 billion annually in sales — around 20% of the New York company’s total revenue. The drugmaker’s patents for the blockbuster medicine have already expired in several European countries, including Spain, Finland and Norway. With cheaper generics now on the market in some places, Pfizer is scrambling to make up the lost profits. Last week, a company announcement hinted at restructuring and selling off parts of the business, but Pfizer execs have also found a way to buy a little more time.
The company has taken advantage of legislation passed in the EU in 2007 that allows a six-month patent extension for developing child-friendly versions of drugs. The law, similar to one passed in the US the same year, aims to create incentives to test and authorize drugs for youngsters. After submitting pediatric data to the European Medicines Agency in November 2009, a chewable, grape-flavored formulation of the drug was approved for children in March. The medicine will hit markets in November. This, in turn, will extend Pfizer’s exclusive patents on Lipitor — for children and adults alike — until May 2012.
This patent extension could earn Pfizer nearly $800 million during Lipitor’s extra six months on the market. The exceedingly high profits to the company has raised questions about who benefits more from the patent extensions: the kids who gain authorized drug access, or the pharmaceutical companies that get financial payoff.
Around 1 in 500 children have the genetic disorder for which Lipitor could be helpful. This condition, called familial hypercholesterolemia, is characterized by a mutation in the LDLR gene, which encodes a protein that removes cholesterol from the bloodstream. A single copy of the mutation causes early onset heart disease or heart attack at 30 or 40 years; two copies causes high cholesterol, atherosclerosis and even heart disease in children. Reporting earlier this year, Pfizer scientists showed that the drug helped bring down levels of “bad” low density lipoprotein cholesterol with no serious side effects.
So, this pediatric approval might seem like good news for families affected by hypercholesterolemia. However, the Financial Times notes that 20,000 children in the EU are already taking the adult-version of the drug. In light of this common off-label use, Pfizer might do these children more of a service by letting generic manufacturers roll out cheaper alternatives than by making their medicine taste more like candy.
Image: Wikimedia Commons
