Personalized Medicine Could Shake Up Pharma

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"Treating someone in the adjuvant setting—that's your best chance of curing somebody," Pellegrino said in an interview with Bloomberg BusinessWeek. "We're always looking at moving our drugs up the line" into earlier lines of therapy where it would be more beneficial to patients.

Some drug companies, while still shooting for blockbusters, are taking steps to ensure at least a smaller market for certain products if initial clinical trials aimed at the broader patient population end in failure. Pfizer has an ongoing large clinical trial for its new kidney cancer drug Sutent. Separately, the company has asked Genomic Health (GHDX), a developer of clinical laboratory services for cancer, to develop a prognostic test to predict the risk of recurrence in patients with renal cell carcinoma. That test could potentially identify a smaller population of patients who could benefit most from the drug, says Randy Scott, Genomic Health's executive chairman.

"If Pfizer hits a home run and Sutent works broadly in all early renal cancer patients or has dramatic effects, you'd want to give it to all patients as a precaution" after surgery to remove the original tumor, he says. But if not, Pfizer won't lose time in salvaging the drug for a more focused population, he adds. "It's a good example of the drug industry beginning to recognize that [sometimes] these drugs only work in a subset of patients and they need to do a better job with companion diagnostics."

Sales Boost

Dr. Robert Epstein, Medco's chief medical officer, cites other kinds of drugs that have sold better when paired with a companion diagnostic test. One example is the generic drug abacavir, an oral treatment for HIV, to which 6% of patients had a hypersensitivity reaction. Once a certain gene was uncovered that predicts with more than 99% certainty which patients will have the reaction—and the findings were published in The New England Journal of Medicine in February 2008, urging doctors not to prescribe the drug to that subgroup—sales of the drug increased 28% worldwide over the next eight months, according to an article in the November 2008 issue of Personalized Medicine by Felix Frueh, who has since become head of personalized medicine research at Medco.

"You take the worry away [that the drug won't work] and the market share grows," says Medco's Epstein.

Genentech is always looking for biomarkers to help identify patients for its new drugs and builds biomarkers into all of its pipeline products, says Pellegrino. Amgen also touts its "extensive biomarker program," which it views as integral to its development process, but won't disclose how many other drugs it is developing in tandem with companion diagnostics. Bristol-Myers Squibb (BMY) says it's committed to biomarker research but wouldn't say whether that research is being built into its drug development programs.

For the FDA's part, Commissioner Hamburg said on Feb. 25 that she understands that "for [drug] developers to make a substantial investment in [more targeted therapies], they need clear guidelines setting out our expectations and standards for approval."

Bogoslaw is a reporter for Bloomberg BusinessWeek's Finance channel.

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