Monday, October 22, 2007

Phase III Pagoclone trial delayed?

I know how interested every here is in stuttering medication, especially Pagoclone and its clinical trials. Some time ago, I posted a press release from Indevus about their intention to start a Phase III clinical trial in the first half of 2007: see here.

However, as of October 2007, I do not know of any evidence that the Phase III trials have already started, except the existence of waiting lists for the trial. (If you are currently part of such a trial, please let us know.) I can only speculate on this delay. First, any kind of project is often delayed by a few months for any reason. And therefore there is no reason to be concerned. Second, Indevus might have become more hesitant, and are having second thoughts. Such a re-evaluation might be in terms of efficacy, or in terms of a business decision. A re-evaluation also often happen irrespective of efficacy concerns after changes in management, the board of directors, or general strategy. For example, if Pagoclone only applies to a minority, the profit estimates might be severely affected. Such trials are very expensive, often in the tens of million dollars. On the other hand, an approved drug would have significant revenues. Indevus might also underestimate the potential market even as a "minority" drug, and therefore find the risks too high. One concern might also be their cash burn rate, i.e. they spend money without getting money back soon, and they might be looking for a partner like a venture capital fund or another pharmaceutical company to share the risks: see this intriguing conference call one year ago. As I said, I am only speculating by putting myself in their situation, based on public knowledge and based on my understanding of corporate thinking.

We will find out in the next months. However, should Indevus decide against a Phase III trial, which I hope they won't, do not expect a press release. Indevus has already stopped Pagoclone as an anti-anxiety drug and for premature ejaculation, I believe, and a third U-turn would reflect badly on them. A more likely scenario is that they postpone and delay release as long as possible, and the news appears somewhere in an annual report on page 130 in terms of a lack of provisions for Pagoclone. For example, the year-end 2007 balance sheet will be audited in March. So, the longer the trial is delayed, the higher the probability that they have indeed changed their mind.

On a side note, a detailed article on the Phase II clinical studies has not been presented at any conference or published in a peer-review journal, as far as I know. The only information comes from the Indevus press-release and conference calls to analysts: see here. However, at some point, such an academic discussion with a closer look at the data must happen.

Let's hope that this post is a storm in a teacup! Let me know when some of you are participating in a Phase III trial.


Unknown said...

I just found your blog, and myself as a stutterer dropped by Indevus one day (I live in the Boston area) over the summer. They seemed overjoyed that I came in wanting to be part of the trial (I had already signed myself up on the website for the trials). But alas, since that day, I have not heard anything from them at all. I will definitely keep an eye on that company in the local news for updates on the trial.

Tom Weidig said...

Hi Jeffrey,

great to hear from you.

Drop me an email at tom DOOT weidig aattt gmail dooot com.

Best wishes,