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Biodel Announces Accelerated Development Plan for Ultra-Rapid-Acting Insulins: Initiate Phase 2 in 2011; Phase 3 Pivotal Trials in 2012
Date:3/14/2011

sing Humalog® as a comparator in which active dose titration will occur in the first two months after randomization followed by three months of relatively stable dosing.  In these studies, Biodel plans to evaluate efficacy using HbA1c as well as measures of postprandial glucose profiles.  If the results of the Phase 2 testing are successful, the company plans to launch Phase 3 pivotal studies required for approval in 2012 rather than its previous guidance of 2013.

"We look forward to obtaining initial clinical data for BIOD-105 and BIOD-107," said Dr. Alan Krasner, Chief Medical Officer of Biodel.  "Based on pharmacokinetic data obtained in the diabetic swine model, these formulations appear to be very rapidly absorbed, similar to rates of absorption seen with the previously studied Linjeta™ formulations.  Based on last year's clinical data from related formulations BIOD-102 and BIOD-103, we anticipate improved injection site tolerability with BIOD-105 and BIOD-107.  We were very pleased with our end of review meeting with the FDA in which they confirmed study details including the use of Humalog® as a comparator in future clinical trials.  The FDA also confirmed that data from the development program for the new formulations would be classified as a Class 2 resubmission with a 6 month review time."

"We have identified two new formulations with commercial target product profiles that appear to be superior to any of our previous ultra-rapid-acting human insulin drug candidates," said Dr. Errol De Souza, president and CEO of Biodel.  "By achieving our candidate selection milestone and receiving constructive feedback from the FDA during our end of review meeting, we have accelerated the clinical development program of these formulations and plan to initiate Phase 1 clinical testing this month and could initiate Phase 3 testing before the end of 2012."

Biodel now expects to complete the Phase 1 stud
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SOURCE Biodel Inc.
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