Biodel Inc. (BIOD)
F3Q09 (Qtr End 06/30/09) Earnings Call
August 7, 2009 9:00 am ET
Paul Bavier - Corporate Secretary and General Counsel
Sol Steiner - Chairman and CEO
Gerard Michel - CFO, VP Corporate Development
Alan Krasner - CMO
Corey Davis - Natixis
Matthew Kaplan - Ladenburg
Pamela Bassett - Cantor Fitzgerald
Liana Moussatos - Wedbush
John Newman - Oppenheimer
Cory Kasimov - JPMorgan
Previous Statements by BIOD
» Biodel Inc. F1Q09 (Qtr End 12/31/08) Earnings Call Transcript
» Biodel, Inc., F4Q08 (Qtr End 10/31/08) Earnings Call Transcript
» Biodel Inc. F3Q08 (Qtr End 06/30/08) Earnings Call Transcript
Good afternoon and welcome to our third quarter 2009 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 as 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 change; 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; and Gerard Michel, our Chief Financial Officer and Vice President of Corporate Development. Also with us is Dr. Alan Krasner, our Chief Medical Officer. After their prepared remarks, we will open the call to your questions.
Now, I’ll turn the call over to Sol.
Thanks, Paul. Since our last conference call, we made good progress preparing our new drug applications, VIAject, which we plan to submit to the FDA by the end of 2009. Our team is not only completing the 100s of documents needed for the NDA, but also performing additional studies to further differentiate therapeutic potentials of VIAject from currently marketed rapid acting prandial insulins. We plan to include much of this new information in the NDA package, which is why we expect to submit the NDA toward the end of the calendar year.
For example, based on the data from our bridging trial, we believe that our proposed commercial formulation of VIAject has a very low incidence of injection site discomfort, comparable to common therapies and we are conducting a study to demonstrate this definitively for purposes of appropriate labeling upon approval. In addition, we are conducting a pilot study in Type 1 diabetic patients. We utilize insulin pumps. This pilot study is a precursor to a larger pump trial, which will compare VIAject to a marketed rapid acting insulin analog.
By utilizing continuous glucose monitoring, we hope to replicate in actual clinical use that VIAject reduces glycemic variability and enables patients to maintain their blood sugar in the normal range, a greater percentage of time than currently available rapid acting insulin analogs. There is an increasing awareness among physicians that reduction of glycemic variability is associated with less oxidative stress and a more favorable cardio vascular risk profile.
On this note, turning to recent scientific presentations, in June we presented new information on VIAject's mechanism of action and the effects on microvascular function at the American Diabetes Association meeting in New Orleans. Dr. Roderike Pohl, Biodel's Vice President of Research described results of in vitro studies to explain VIAject's mechanism of absorption and rapid onset of action. These studies showed that upon dilution with extracellular fluid, VIAject has a smaller mean particle size compared to rapid acting insulin analogs and much smaller compared to regular human insulin.
In a separate poster, in separate poster's actually Dr. Andreas Pfuetzner and Dr. Thomas Forst from the Institute for Clinical Research and Development in Mainz, Germany presented data that demonstrates VIAject produces less oxidative stress and endothelial dysfunction following a meal in patients with Type 2 diabetes.
VIAject was not only found to be the most effective of the three insulins in reducing postprandial oxidative stress and improving microvascular blood flow and function, it also produced a profile of responses more typical of healthy individuals. Both the presentations are available on our website.
Also at the ADA conference, the newsletter Closer Look reported on a survey of a 102 healthcare professionals conducted by Close Concerns, a healthcare information firm specializing in the business of diabetes. This survey showed increasing recognition of glycemic variability as an important and A1c-independent risk factor for diabetes complications.
In addition, over 90% of the respondents believe there is a need for insulins that work faster than current rapid acting analogs, an advantage that we have repeatedly demonstrated. The respondents were also asked to comment on the likelihood that they would prescribe specific new products upon approval.
While the authors stress that their survey may not be a representative sample, we are nonetheless pleased that over 80% of the respondents said they plan to try VIAject if it is approved. We believe this is because of the general belief that our faster meal-time insulin could lead to better glycemic control and outcome. We find these observations to be quite encouraging.