Saturday, September 27, 2008

Breaking News: Pagoclone is going to Phase IIb

LEXINGTON, Mass., Sept. 26 /PRNewswire/ -- Indevus Pharmaceuticals, Inc.(Nasdaq: IDEV) today announced that it has signed a development, license and commercialization agreement with Teva Pharmaceutical Industries Ltd. for the exclusive, worldwide rights to pagoclone. Indevus previously announced promising data from its 8-week, placebo controlled, double-blind, multi-center Phase II trial in patients with persistent stuttering which showed that pagoclone produced a statistically significant benefit in multiple primary and secondary stuttering endpoints compared to placebo. Pagoclone is a novel member of the cyclopyrrolone class of compounds and acts as a gamma aminobutyric acid (GABA) selective receptor modulator.

Under the terms of the Agreement, which is subject to applicable regulatory clearances and customary conditions, Indevus will conduct and Teva will reimburse Indevus for its expenses for a Phase IIb study. The placebo-controlled study will involve approximately 300 patients with stuttering in the U.S. treated for a period of six months and is expected to commence enrollment by Q1 2009.

Following the completion of a successful Phase IIb study, the Agreement provides for Indevus to participate on a 50/50 basis with Teva in the U.S.,sharing development and marketing costs, and splitting future profits, in addition to receiving milestone payments. Under certain circumstances, either party may convert the Agreement from the 50/50 arrangement to a royalty structure where Teva will be responsible for all development and commercial costs in the U.S. and Indevus would receive royalties on net sales, in addition to milestones. In either case, if the arrangement continues, Teva will be responsible for the conduct of the Phase III program.

For territories outside of the U.S., Teva will be responsible for all future development and commercialization and Indevus will receive milestones and royalties on net sales.

Under the 50/50 participation, Indevus could receive up to $92.5 million(including the Phase IIb study expenses) in U.S. and European development milestones and R&D reimbursement. In the event of a conversion to the royalty structure, in addition to the $92.5 million of milestones and reimbursements,Indevus could receive up to $50.0 million in U.S. based sales threshold milestones.

We are excited that we have partnered pagoclone with a leading pharmaceutical company with a focus on central nervous system conditions,"said Glenn L. Cooper, M.D., chief executive officer and chairman of Indevus."There are currently no approved drugs anywhere in the world for patients with stuttering. Pagoclone has tremendous potential to become a highly significant commercial product, as well as to provide a ground-breaking therapy to then early three million Americans and millions of patients around the world who are afflicted with this condition. The deal we have negotiated with Teva allows us to conduct a definitive Phase IIb trial, funded by our partner. If the trial is positive, we believe that both companies will have a unique opportunity to commercialize the first pharmaceutical product for the millions of patients who stutter.
(Thanks to Holger!)

8 comments:

Scott said...

Tom,

Why the need for a phase IIb study? What is a phase IIb? Isn't it the same double blind study they performed last but with more participants? Isn't that in essence a Phase III?

georgemiachaels said...

I am looking forward to the trials and hope that Pagoclone gets FDA approval soon.
On a side note, I consulted Dr.Maguire a couple of weeks back and he prescribed me Abilify. First first 2 days I didn't feel any change other than I couldn't sleep well but after that, there is a remarkable decrease in my blocks. I don't think about word substitutions anymore and my stutter has decreased by about 60-70% so far. I am not sure if the positive effects would decrease with time. I have not experienced any side effects yet.
I am looking forward to Paglocone.

Anonymous said...

What a joke!! I guess they will study and test pagoclone until most stutterers are either too old to care or dead. Unregulated, greedy bankers on wall street are getting away with destroying century old financial institutions while a couple of million stutters are prevented by cumbersome government regulations to access potential stuttering relief from a harmless, promising new medicine.

Anonymous said...

http://en.wikipedia.org/wiki/Clinical_trial#Phase_II

Anonymous said...

Georgemiachaels,

Do you not have any side effects from the drug?....perhaps tiredness or fatigue etc

What dose are you on?...Its likely that you will have to increase the dose to keep the same results over time as the body gets used to the drug.

Pagolcone wont be here until 2010/2011 EVEN is it gets through the trials.

I wish you all the best

georgemiachaels said...

Anonymous,
No, I have not experienced any side effects so far. No restlessness or sedation.
As I mentioned before, I could not sleep well for first 2 days but after that it was all fine.I will get my blood tests for any glucose level increase.
I am initially on 2mg dose which will increase to 5mg soon. I had pretty good 10 days for my fluency so far and I can only hope that effects don't fade away soon.

Tom Weidig said...

To George...

please stay in touch with me: tom dot weidig at gmail dot com.

I would interested in hearing from your experiences.

Best wishes,
Tom

Anonymous said...

Hi Tom ,
Can you please advise us when phase III is planned to starts?
As it been 2 years since your last post.