Targeted drugs, personalized medicine, stratified therapy--whatever you call it, using biomarkers to identify particular patients for particular drugs has been hailed as a boon for patients and a savvy strategy for pharma.
Advocates can talk up approval numbers, labeling changes and phase III therapies. But it's according to the 80/20 rule: A small number of pharma companies account for the lion's share of targeted meds. And the star of personalized medicine is just the company you'd expect: Roche ($RHHBY), with its drug-plus-diagnostic approach to cancer R&D, its stable of blockbuster HER2-positive therapies, and a total of almost $20 billion in sales from its targeted drugs.
Just ask Diaceutics, the U.K. research firm, which keeps close tabs on diagnostics-aided medicine. Yes, the number of FDA-approved drugs linked with a particular biomarker has leapt over the past three years, to more than 80 from just over 20. And while only 7 new drugs with companion diagnostics have made their market debuts, 53 others have new FDA labeling that flags safety-related biomarkers--bringing the percentage of targeted therapies on the market to 19% from 6% in 2010.
In the pipeline, the progress is even more dramatic. Among the top 12 drugmakers active in the field, biomarker-tagged products make up half of the total under review or in phase III.
Company by company, the picture is a lot more mixed. Diaceutics analyzed companies' personalized medicine efforts to determine which are best prepared for a biomarker-driven world. The leader was Roche, of course, far beyond the rest in organizational infrastructure and commercial savvy. Johnson & Johnson's ($JNJ) Janssen unit and Novartis ($NVS) also separated themselves from the pack, with marketing chops and overall organizational prep. Diaceutics calls these three "disruptors"--they're essentially breaking new trail.
The next-best-prepared group, which Diaceutics calls "breakaways," includes AstraZeneca ($AZN) and Bristol-Myers Squibb ($BMY), which is actually on the cusp of joining the disruptor field. Pfizer ($PFE) is coming up, too, leading the rest of the pack.
The followers? That would be Eli Lilly ($LLY), Sanofi ($SNY), Amgen ($AMGN), Merck ($MRK), GlaxoSmithKline ($GSK)--all of which have solid work in personalized medicine, but are less prepared for a big shift into the area, Diaceutics says. Boehringer Ingelheim lags the group, but at least it's on the chart.
Besides the obvious bonus of only treating patients likely to benefit from a drug--weeding out any who'd only suffer side effects--one of the reasons companies are going after targeted drugs is that they theoretically can command higher prices. They're intended for much smaller populations, after all; Pfizer's Xalkori, for instance, is meant for less than 5% of lung cancer patients.
And then there's the R&D cost-and-speed argument. In the Tufts Center for the Study of Drug Development's recent report on the cost of drug R&D, Xalkori and Roche's melanoma med Zelboraf were ID'd as the fastest-through-the-pipeline in recent years. Early to market means less cost and more time to sell before copycats hit the market.
- read the Diaceutics report
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