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The End of Blockbuster Drugs

My colleague Paul Kedrosky also gets it when he pointed out this weekend that the Celebrex dust-up is one more reason to nail shut the coffin on the lucrative days of megablockbuster drugs. The future of drug development lies in pharmacogenomics -- a big word that essentially means targeted, personalized medicines.

Instead of developing one drug that treats 20 million people relatively poorly and with a lot of side-effects, why not apply the genetics of disease --and the way different people respond to disease -- to discover dozens of drugs that treat smaller patient populations well and with fewer side-effects? Sure, the golden era of personalized medicine has yet to arrive, but Genentech's (DNA) breast cancer drug Herceptin is proof that such a model can be successful and profitable.

The biotech sector understands this, and my guess is that Big Pharma will follow. (This is a good reason for long-term investors to like the biotech sector.)

The FDA has more than Celebrex on its mind: The agency also must figure out what to do with AstraZeneca's (AZN) lung cancer drug Iressa. On Friday, AstraZeneca said results from a large phase III study showed that Iressa does not confer a survival benefit to patients with advanced non-small-cell lung cancer.

The FDA approved Iressa in 2003 under a program that allows drugs for serious, life-threatening diseases like cancer to be approved based on certain surrogate markers for clinical benefit. In this case, AstraZeneca had data showing that Iressa shrank tumors in patients with advanced non-small-cell lung cancer who had essentially run out of other treatment options.

Under the so-called subpart H regulatory guidelines, the FDA approved Iressa with the condition that AstraZeneca would run another clinical study to show that Iressa's ability to shrink tumors would lead to improved survival, which is the gold standard in cancer drug efficacy.

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