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Biodel Inc. (BIOD)
F1Q09 (Qtr End 12/31/08) Earnings Call Transcript
February 5, 2009 5:00 pm ET
Erik Steiner – VP, Operations
Sol Steiner – Chairman, President & CEO
Gerard Michel – CFO, VP Corporate Development & Treasurer
Alan Krasner – Chief Medical Officer
Corey Davis – Natixis
Pamela Bassett – Cantor Fitzgerald & Co.
Matt Kaplan [ph] – Denver Hillman [ph]
Cory Kasimov – JPMorgan
John Newman – Oppenheimer
Liana Moussatos – Pacific Growth
John Ossenus [ph] – Leerink Swan
Ladies and gentlemen, thank you for standing by. Welcome to Biodel’s first quarter 2009 earnings conference call. (Operator instructions).
I would now like to turn the conference over to Erik Steiner, Vice President of Operations. Please go ahead.
Previous Statements by BIOD
» Biodel Inc. F3Q09 (Qtr End 06/30/09) 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
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.
Now 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, Erik. I'll begin with a quick update on our regulatory plans for VIAject. I can confirm that we met with the FDA officials last month to review our Phase III results, answer their questions and discuss our options for submitting a New Drug Application for VIAject as a treatment for diabetes. I'm not going to comment on these discussions until after we have received the FDA minutes from our meeting, at which time we will announce our regulatory plans publicly. I expect this will happen sometime in March and I appreciate your patience until then.
I can however comment on the bioequivalence study of VIAject, which we completed last month. The news here is quite good. We enrolled 40 patients in a single center double-blind study to show the bioequivalence and pharmacokinetic profile of different formulations of VIAject and to examine injection pain in patients with Type I diabetes. Remember, our Phase III study tested a two part 25 IU/cc formulation of VIAject, which required reconstitution and a four times greater injection volume versus the 100 IU/cc formulation of Humulin, which does not. We chose the crossover design to increase the power of the study and so that each patient could act as his or her own control. Each patient was randomized to receive a single subcutaneous injection of one of the formulations on each visit.
I'm pleased to report that bioequivalence was demonstrated between the premix 100 IU/cc liquid formulation of VIAject and the 25 IU/cc lyophilized formulation of VIAject, which has already been shown to have meaningful clinical benefits versus regular human insulin.
As previously discussed, we believe the injection pain seen in our Phase III trial was due to the greater injection volume necessitated by a 25 IU/cc formulation. We are pleased to report that the findings in this study were consistent with our hypothesis. Each of the 40 patients in the trial received a 25 IU/cc and 100 IU /cc formulation of VIAject and was asked to compare any injection pain experience with each formulation of the pain associated with the prandial insulin they normally use.
While 20% of the subjects reported that the pain upon injection was moderately or greatly increased when injected with the 25 IU/cc formulation only 5% of the subjects reported moderately more pain and no patients reported greatly more pain when injected with the 100 IU/cc formulation. While only 30% of subjects receiving the 25 IU/cc formulation reported no pain with injection, fully 45% of subjects receiving 100 IU/cc formulation reported no pain with injection. The balance of the study subjects reported little to no difference in pain when comparing either the 25 IU/cc or the 100 IU/cc formulation to the prandial insulin that they normally use.
We believe these findings validate a shift to the 100 IU/cc formulation, which has comfort, cost, and convenience advantages that make it our preferred formulation going forward. It is less expensive to produce; it is more convenient to deliver, because it can be used in vials and cartridges, with currently available insulin syringes, pen injectors, and pumps, all of which are important for its clinical and commercial potential in the insulin market. We are very pleased with these findings, which we have also reported to the FDA.
That concludes my prepared remarks. Now I will turn the call over to Gerard to review our financial results.
Thanks, Sol. Our results for the first quarter of fiscal year 2009 reflect reduced clinical activity with VIAject, ongoing formulation work, increased stockpiling of bulk insulin, and the continued careful management of expenses.