A good piece on the potential for personalized medicine with some of the new cancer treatments focussed on molecular abnormalities, and the economic challenges of drug development for smaller groups of patients:
It costs something like $1 billion to develop a new drug and bring it through testing to market. That cost, plus profit, needs to be spread over a lot of patients.
For blockbuster biologics like Gleevec or Genentech Inc.’s Herceptin, which treats HER2-positive breast cancer, the right patients are numerous and easily identifiable. But most mutations — or combinations of mutations — are much rarer, making the markets for drugs to address them much smaller. Sledge points, for example, to Pfizer’s Xalkori, or crizotinib, which treats lung cancer in just 5 percent of patients with a particular mutation.
As cancers and treatments are defined more and more precisely at the molecular level, nearly every form of cancer could become an “orphan disease” with a narrow, potentially unprofitable market for drugs.
“Your markets become a lot smaller,” said Meredith Buxton, the program director of I-SPY, a University of California at San Francisco program doing human trials of potential breast cancer drugs. “That’s the dilemma. The more people learn that breast cancer is not a homogeneous disease — that it’s many different little diseases — the less the value for a company to put in the $1 billion for a drug that’s going to be for a fairly specific and small-market.”