Biodel Inc. F3Q08 (Qtr End 06/30/08) Earnings Call Transcript

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2008-08-06 16:15:25.0

Tags: Biodel Inc.

Question-and-Answer Session

Operator

(Operator Instructions). We will go first to Cory Kasimov of JPMorgan.

Cory Kasimov - JPMorgan

Hello and good afternoon. Thank you for taking the question. First of all, Sol, can you give us a little bit more of a specific progress report on the formulation work you are doing with VIAject, in other words what else needs to be done to go to the 100 unit liquid?

Solomon Steiner

Well, what you do to be done and good deal of which has been done as you make 3 commercial batches of it. Then you do stability work on the batches that you make, and you do a bioequivalent study where you compare the various formulations to each other and a crossover design using glucose clamp technique. Does that answer of your question?

Cory Kasimov - JPMorgan

Yes. Well, let me put it in another way. When do you expect to be done with all this work?

Solomon Steiner

Let's say, it is a good question, I am thinking because they are several different batches, they will have different times. Suffice it to say that all the manufacturing is either complete or will be completed in relatively short time.

Cory Kasimov - JPMorgan

Okay. Are you happy with everything you have seen to-date?

Solomon Steiner

Yes, that is right. The bioequivalent study should be completed in time. Well, the bioequivalent study should be completed before the end of the year, including the report. So that could be dropped into an NDA filing.

Cory Kasimov - JPMorgan

Okay. Next, could you still elaborate a little bit on your thinking these days regarding the partnership, how things may or may not have changed and now that you are six weeks from the data, within six weeks from the data?

Solomon Steiner

There is a lot more interest now than there was a year ago. I think that is a fair statement to make. We are in discussions with a number of potential corporate partners. You never know how it is going to come out until it is over even then you are not so sure. We are pleased with the discussions that we are having and we think that the highest probability is that when we launch, we will launch with a corporate partner, doing great majority of the sales, distribution, and marketing.

Cory Kasimov - JPMorgan

Okay. Now that you have completed these 2 pivotal Phase III trials, how should we be thinking about R&D going forward? As part of that question, assuming that these two trials are positive, how soon would you be launching subsequent studies versus the analog?

 

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