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Biodel Reports Second Quarter Fiscal Year 2011 Financial Results
Date:5/5/2011

Business Review

  • Biodel has selected two new recombinant human insulin-based formulation candidates, BIOD-105 and BIOD-107, for clinical development as ultra-rapid-acting mealtime insulins for the treatment of diabetes.  Following recent discussions with the U.S. Food and Drug Administration, Biodel now plans to accelerate the timelines for clinical testing of these new formulations.
  • Biodel has initiated a Phase 1 trial of BIOD-105 and BIOD-107 in a double-blind, three-period cross-over study in patients with Type 1 diabetes.  This trial will evaluate the pharmacokinetic, pharmacodynamic and injection site tolerability profiles of the two experimental insulins relative to Humalog® when delivered by subcutaneous injection.  
  • In parallel with the Phase 1 clinical trial of BIOD-105 and BIOD-107 described above, investigators at Oregon Health and Sciences University will soon initiate a similar comparative study evaluating the use of these formulations and Humalog® when delivered by insulin pumps.  The results of the two Phase 1 trials will be used to select the best formulation for Phase 2 clinical testing, planned to initiate later this year and Phase 3 clinical testing planned to initiate in 2012.
  • Biodel recently named Dr. Brian Pereira as chairman of the company's board of directors.  Dr. Pereira has been a board member since November 2007 and, as an experienced biotechnology executive, brings invaluable expertise to the company.  Former chairman Dr. Charles Sanders will remain a member of Biodel's board.

  • Conference Call and Webcast Information

    Biodel's senior management will host a conference call on May 5, 2011, beginning at 4:30 pm Eastern Daylight Saving Time, to discuss these results and provide a company update. Live audio of the conference call will be available to investors, members of the news media and the general public by dialing 1-877-303-8028 (United States)
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    SOURCE Biodel Inc.
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