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Changing the Market for Orals: the Exubera Challenge

This article was originally published in RPM Report

Executive Summary

Investors are betting that the new inhaled insulin, Exubera, will simply take share from existing insulins. But managed care groups might prefer, given Exubera's likely cost and medical benefits, that it take share from the most expensive orals, the glitazones Avandia and Actos.

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Insulin Delivery: Still Waiting to Exhale

After the commercial failure of Exubera, is inhaled insulin dead? Not at all. Exubera failed for very specific reasons: a cumbersome device, non-standard dosing, and no real clinical utility. The Exubera snafu has eroded the commercial value of inhaled insulin, but Nektar may be the best-positioned company currently competing in the inhaled insulin space. Nektar can afford to re-partner its version for less, because Pfizer has already paid for the bulk of the drug development work.

The Avandia Penumbra: Remapping Diabetes Drug Development

The implosion of Avandia has raised several critical issues for diabetes drug developers, including whether companies can still rely on glycemic control as the primary endpoint for approval and the extent to which late-stage comparative trials conducted versus Avandia are still useful. The decisions FDA makes in the wake of Avandia will also be important milestones affecting other therapeutic categories, as they will reflect how the agency is assessing and monitoring drug safety generally.

Januvia: Defining Primary-Care Success and Risk

Januvia's fast development and successful launch exemplifies Merck's new biomarker-based R&D operation and its focused "one Merck" strategy. But the drug also provides an ideal case study of why doing everything right in primary care brings with it extraordinary risks: the key elements of Januvia's success -- blazing speed through development and the extraordinary safety profile on which its commercial triumph depends -- also define its most dangerous commercial liabilities.

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