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MannKind Says Inhaled Insulin NDA On Track, Resumes Search For Partner

This article was originally published in The Pink Sheet Daily

Executive Summary

Afresa Phase III studies are complete, though FDA wants bioequivalence trial to support new inhaler device.

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MannKind files Afresa, downplays inhaled aspect of its insulin:

Almost a year and a half after Pfizer admitted commercial defeat for the first inhaled insulin, Exubera, last-drug-developer-standing MannKind has filed the NDA for its inhaled insulin Afresa. The March 16 announcement continues MannKind's practice of downplaying the inhaled aspects of its insulin, stating that "the feature that distinguishes Afresa from all other insulin products is not the route of administration - it is the pharmacokinetic profile." Although the other manufacturers working on inhaled insulins abandoned the projects, MannKind persevered, arguing that the efficacy offered by the quick action (peak insulin levels in 12-14 minutes, mimicking the release of mealtime insulin in healthy people) - not convenience - is the rationale for the product. The firm also recently announced its plan to buy the German plant that produced Pfizer's Exubera. Having both the regulatory filing accomplished and the manufacturing capability should give the biotech a leg up in partnering talks - which had been put on hold after a lung cancer signal was detected in Exubera post-market data (1"The Pink Sheet" DAILY, Nov. 10, 2008)

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