Friday, November 30, 2007

Bad news for Pagoclone

Unfortunately, I have bad news to report. Some time ago, I reported here on my suspicion of a delay for the Phase III trial of Pagoclone which was supposed to start in Early 2007. I speculated that Indevus might consider the risks and investment as too high. I also warned that they would not announce such a delay or stop, but that we would only know about it by absence of any news, especially in the Year End report. That's exactly what is currently happening. They have just published their Fiscal 2007 report (see here on CNN), and Pagoclone (unlike in the 2006 report) is nowhere mentioned. Except when Dr Cooper from Indevus cryptically says:
Finally, through our other business development activities, we successfully outlicensed aminocandin and IP 751 and we have discussions ongoing for the outlicensing of pagoclone, all designed to further focus our efforts in urology and endocrinology
Compare his statement in last year's report:
We are also optimistic about the positive results of our pagoclone Phase II study in stuttering and the upcoming initiation of our Phase III clinical program.
Unfortunately, my instincts tell me that the "on-going discussion" is a way of spinning bad news. Instead of saying "we are not going forward with Pagoclone and this is our third aborted attempt to find a disorder for Pagoclone", they say "we are in on-going discussion for outlicensing of Pagoclone. We are doing good because we make money by out-licensing". You can always say that you have on-going discussions, and of course they are secret so you can't reveal any details.

There was an analyst conference call today. Surely, some analyst is going to ask the question. If they are any good... If anyone has the link or transcript, please let us know.

10 comments:

Ora McCreary said...

The link to yesterday's conference call is on the Investors page of the Indevus website: http://phx.corporate-ir.net/phoenix.zhtml?c=92810&p=irol-irhome

It's an hour long.

Tom - Let's see if you and I can outdo one another in pessimism... you say "Surely, some analyst is going to ask the question. If they are any good." My speculation is that NO ONE will even ask the question!

Dave from Boston said...

Hi Tom, This is a dumb question but I wanted to ask it.

So when they say out-licensing, does that mean that another company can pick up from where they left off and then still have a phase III trial OR does it mean they would need to start from scratch OR neither of those?

It is definitely sad news. I knew something was going on because I have my Google alerts set and awhile back there was buzz everyday on Pagoclone and then it just stopped.

Dave

Tom Weidig said...

Hi Dave,

I don't know exactly. I cannot see why another company cannot pick up from Phase II and do a Phase III.

It might well be that another company takes over. Maybe the risks were just too high for them, and at the same time it is not their business focus.

Anonymous said...

I think that the reason is purely economical. So sad... the results are here but there is not enough benefit! Also maybe another medicine is in sight which will ruin the pagoclone market. Anyway, can you imagine the people for whom the pagoclone was life changing (the participants) and their disapointment when they're reading this?

Anonymous said...

I'm just glad the bat picture is not popping up when I open this blog!
Lynne

What does Dr. Maguire have to say?

Tom Weidig said...

I hope I won't become unpopular with my readers (especially those that "relied" on Pagoclone) and Gerry. The messenger of bad news is never popular, even though he/she is not responsible for the bad news!

The concept that another drug is better is an interesting one, and I haven't thought about it, but I am very skeptical. It also sounds a bit like "the miracle hasn't occur, because a super-miracle will occur later."

Liv said...

I believe that this announce can be in consequence of last studies that atribbute stuttering cause to anatomical differences in the brain. If stuttering result from a structural cause and not functional, the medicament loses its reason to be.

bwapplegate said...

Hello,

IDEV typically does outlicensing deals on compounds they are developing. They've outlicensed several of the ones in their pipeline, including Sanctura and Sanctura XR, which are their flagship medications.

Outlicensing essentially entails up front payments to cover the costs of the Phase III trial in return for the ability to sell the drug once it is approved. Thus, IDEV is looking for a big pharma to come in and offer XXX million for the rights to the medication. They'd give milestone payments - to initiate PIII trials, at the completion of enrollment, at the submissison of the NDA to the FDA, and on approval. After that, IDEV would typically get a royalty payment based on sales of IDEV.

This situation is interesting because:

-IDEV has a colorful past, in which it was tested as a med for GAD and panic disorder but failed. Most people think that the success of pagoclone will not bew for stuttering, but for off label use for anxiety.

-Trial design and cost issues. Stuttering trials are somewhat difficult to pull off. There are hazy outcome indicators, difficulties in standardizing patient accrual, and other trial issues. the Phase II trial took something like 15 months to enroll 120 subjects over 15 sites. That's not exactly a high enrollment rate.

-The FDA wants the medication tested on children as part of the approval process. this complicates the trial design, and further complicates the trial and significantly adds to the cost.

I do think that they ultimately will partner with someone in the next quarter to 6 months and that the trial will proceed after that. My sense that IDEV is trying to get a sweetheart deal.

Anonymous said...

AS a stutterer myself, I understand this bloggers negativity. It's easy to be negative thinking we were born with this deficiency in speech. But why hasn't anybody thought that IDEV is looking for a partner, like Pfizer, like they did before with Pagoclone. Remember Pagoclone used to be on the market for anxiety. That was under IDEV but Pfizer marketed it. Or in today's terms, it was outlicensed. I think the same is happening with today's Pagoclone. This, to me, is GREAT news for the future of Pagoclone.

Anonymous said...

Spoke to someone close to Indevus the week before Christmas. At that time, there were four companies negotiating for the rights to develop Pagoclone.

Each of the deals was different, but it left IDEV in a good position to push for more value for shareholders. Yes, that does lead to a delay in the deal and a delay in the time to market that is frustrating for stutters.

On the other hand, that much interest should give stutters confidence that whoever buys the rights to develop Pagoclone is very interested in pursuing the market.