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Biodel, Inc. (BIOD)
F4Q08 Earnings Call
December 10, 2008 8:00 am ET
Solomon Steiner - Chairman and Chief Executive Officer
Erik Steiner – Vice President of Operations
Alan Krasner – Chief Medical Officer
Gerard Michel – Chief Financial Officer
Liana Moussatos - Pacific Growth Equity
William Ho – Banc of America Securities
Pamela Bassett – Cantor Fitzgerald & Co.
Previous Statements by BIOD
» Biodel Inc. F3Q09 (Qtr End 06/30/09) Earnings Call Transcript
» Biodel Inc. F1Q09 (Qtr End 12/31/08) Earnings Call Transcript
» Biodel Inc. F3Q08 (Qtr End 06/30/08) Earnings Call Transcript
Good morning and welcome to our fourth quarter and year-end conference call. Before we start, let me remind you that we will be making forward-looking statements covered under the Private Securities Litigation Reform Act of 1995, and that all of our projections and forward-looking statements represent our judgment as of today. These statements may involve risks and uncertainties that are described more fully in our filings with the SEC which are also available on our website. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our estimates changes, and therefore you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.
Joining us on today’s call are Dr. Sol Steiner, Biodel’s Chairman and Chief Executive Officer; Dr. Alan Krasner, our Chief Medical Officer; and Gerard Michel, our Chief Financial Officer. After their prepared remarks, we will open the call to your questions. Now, I’ll turn the call over to Sol.
Since we reported results of our Phase III studies with VIAject in September, we have continued to analyze the data, work with regulatory consultants to prepare for upcoming discussions with the FDA about our findings, and initiate other important activities to expand the clinical potential of VIAject.
Our ongoing analysis of the Phase III trials suggest that there are specific factors inherent in our patient population that explain our results and support our treatment of data from India which were inconsistent with results from the United States and Europe. We believe there is a good case for approving VIAject with the analytical method we used, and we look forward to meeting with the FDA next month to discuss it. That meeting will determine whether we proceed directly toward an NDA filing for VIAject or conduct another study before we file. We are already planning to do another study with VIAject in patients with type 1 diabetes. In addition, we are completing the bioequivalent study of VIAject which Alan will describe in a moment.
In the meantime, we are keeping a tight lid on expenses to ensure that we can execute our clinical program effectively in this challenging financial environment. I believe we have the resources to advance our pipeline and execute our current plans over the next two years. In closing, I wish to reiterate our belief that VIAject has unique clinical benefits, safety advantages, and commercial potential, that the data from our studies are compelling, and that we are working diligently to prepare for several key value-creating milestones in the months ahead. They include our meeting with the FDA, the completion and analysis of our bioequivalent study, and the launch of the next type 1 study.
Dr. Alan Krasner will now describe our clinical plans in more detail.
Alan Krasner, M.D.
We recently began enrolling patients in a single-center double-blind study to show the bioequivalence and pharmacokinetic profiles of 4 different formulations of VIAject in patients with type 1 diabetes. As a reminder, our Phase III study tested a two-part 25 IU/mL formulation of VIAject which required reconstitution, compared to the 100 IU/mL formulation of regular human insulin which does not. The purpose of this study is to demonstrate the bioequivalence of a one-part liquid 25 IU/mL formulation, a two-part 100 IU/mL formulation, and a one-part liquid 100 IU/mL formulation compared to the two-part 25 IU/mL formulation of VIAject used in the pivotal trial.
We chose a crossover design, so each patient can act as his or her own control. This strategy increases the power of the study. Each patient will be randomized to receive a single subcutaneous injection of one of the 4 dose formulations on four different visits. We are enrolling approximately 40 patients in this study and expect to complete the trial for topline results during the first calendar quarter of 2009. We believe this study will demonstrate that the 100 IU/mL liquid formulation of VIAject has a PK and PD profile that is not significantly different than the 25 IU two-part formulation of VIAject which has already been shown to have meaningful clinical benefits versus regular human insulin.
VIAject has also shown favorable effects on microvascular blood flow in patients with type 2 diabetes. These findings were reported last month at the Diabetes Technology Conference by Dr. Thomas Forst from the Institute for Clinical Research and Development in Germany.
We’re also planning to launch a study with VIAject in type 1 patients next year, but I’ll reserve my comments on the design and size of that study until we get closer to the start of patient enrollment.
Now, I’ll turn the call over to Gerard Michel to review our financial results.