1. In Vivo

AstraZeneca's Nuanced View of Cancer Drug Development

 
• By Mark Ratner

With its small-molecule signal transduction inhibitor Iressa, the first approved drug targeting the EGF receptor, AstraZeneca became an early mover in the development of molecularly targeted cancer drugs. But Iressa also became the poster child for the difficulties associated with targeted therapies when a Phase III trial failed soon after the drug was approved. Iressa's ups-and-downs has brought home the need for "guided empiricism" to link targets in the clinic to markers and dosing. Yet even as AstraZeneca and others make connections linking target biology to disease propensity or status, clinical drug development continues. And if history is a guide, industry should expect more Iressa-type missteps.

When analysts talk up AstraZeneca PLC 's near-term growth prospects, they focus on major market introductions in its two biggest franchises: esomeprazol (Nexium), the follow-on to the genericized proton pump inhibitor omeprazole (Prilosec) in heartburn, and the cholesterol-lowering rosuvastatin (Crestor), along with the anticipated approval of the direct thrombin inhibitor ximelagatran (Exanta), a potential replacement for warfarin (Coumadin). But on a percentage basis, revenue growth in oncology, the company's third-largest franchise, has been outpacing those other segments, approaching $2 billion for the first nine months of 2003—an 18% growth rate, versus 9% growth in cardiovascular and a 6% decline in gastro-intestinal.

And oncology is growing despite an 83% decline in former blockbuster tamoxifen (Nolvadex), whose US revenues have dropped to $40...

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