Monday, December 03, 2007

Pagoclone outlicensing negotiations

One reader, Ora from New York, called Indevus directly and asked them! Here is what he wrote to me about his re-collection of the phone call. I want to make clear that I was not part of this phone call and cannot verify any statements:
Current plan is to partner the drug with a larger firm which specializes in central nervous system drugs. Pagoclone is a legacy drug for Indevus. It went through tests for generalized anxiety disorder. They discovered in the process that it helped stutterers who participated in the trials, and that the benefit subsided after treatment was stopped. They’ve gotten some good info from the Phase II open label extension (since mid-2006).
In the meantime, Indevus' corporate focus has changed. They’ve acquired another company this year. Their corporate focus has shifted toward urology and endocrinology, and pagoclone no longer fits. Although they are still positive on pagoclone, they’ve had to make a corporate decision whether to proceed with it themselves, or devote their attention to drugs within their core focus. They decided to outlicense pagoclone to another company.
The outlicensing talks are “in late-stage discussions”, and they hope to agree with partner by end-of-year. They are in “end stage negotiations”. Timing is uncertain to a degree, but they’re hopeful that they’ll ink the agreement by end-of-year. Might extend into first quarter 2008. They recommend keeping an eye out for Indevus press releases regarding the outlicensing deal, and then closely follow the plans of the new company, including contacting their corporate communications department.
One encouraging fact is that the safety data is very good. This data has come not only from the 132 participants in the stuttering study, but also from the previous studies for anxiety and premature ejaculation, so altogether they have safety data for (I think) about 1600 people.
They have had “end of phase II meeting” with FDA. FDA has asked them to do pediatric studies or incorporate into their trial design; if not, the drug would undoubtedly be prescribed by doctors for off-label use. In the US, any FDA-approved drug can be prescribed by a doctor for any condition, not just the approved diagnoses. So the FDA wants them to design their tests to include children so they have some real data instead of guesses and extrapolations.
I asked what the Phase III study would look like. It would depend on the new company. The design of the trial would depend on discussions with the FDA, and would be adjusted as necessary “to get this through”. The FDA has already been giving them a lot of feedback.
There is nothing really new. It is important to watch their actions on the outlicensing as opposed to their words. We cannot judge the state of such negotiations and need to wait until a public announcement by both companies.

3 comments:

ora said...

I was excited to talk with the Indevus representative yesterday and to discover that they have not abandoned pagaclone, which is what we have all been fearing in recent months based on the relative lack of activity or information after the September 2006 announcement of the Phase III study. (At that time they announced that they "will initiate a Phase III trial in the first half of 2007" - http://findarticles.com/p/articles/mi_m0EIN/is_2006_Sept_26/ai_n16838040 )

Nonetheless, I agree entirely with Tom's comment "It is important to watch their actions on the outlicensing as opposed to their words. We cannot judge the state of such negotiations and need to wait until a public announcement by both companies." We all know of cases where deals that were confidently described as all-but-certain fell through at the last minute.

At this point I think I'm more optimistic than Tom is, but I agree with his caution.

ora said...

P.S. The Blogger software apparently doesn't make it easy to click on long links. Here's the link again, cut up in pieces to be visible:

http://findarticles.com/p/
articles/mi_m0EIN/is_2006_Sept_26/
ai_n16838040

Shane Ritchie said...

Anxiety is a part of life for everyone. It is quite normal to feel anxious over certain circumstances however it becomes a problem when a person is anxious over seemingly small, trivial or non existent factors. This is known as an Anxiety Disorder and is a recognized mental illness. http://www.xanax-effects.com/