Saturday, December 01, 2007

A more sophisticated look at Pagoclone

bwapplegate posted a more sophisticated and more optimistic analysis of the current state of Pagoclone than I did in my last post, here! He seems to be an analyst. Here is his analysis:
Indevus (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 be 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.

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