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jq1234

07/17/12 5:17 PM

#145611 RE: ghmm #145609

JCR GSK alliance had been out there for quite some time. GSK entered agreement with JCR and Prosensa for rare disease in 2009.

http://www.gsk.com/media/pressreleases/2010/2010_pressrelease_10014.htm

Its interesting Amicus now will have access to an ERT without having to spend a lot to get one.



That would be much further down the road. As far as I know, JCR's ERTs are not in clinical stage yet.
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turtlepower

07/21/12 10:00 AM

#145843 RE: ghmm #145609

I imagine Phase 3 will only be with their ERT which should give them a leg up on Replagal and Fabrazyme.



The P2 interaction study with both Replagal and Fabrazyme is still ongoing and the PR stated that they were committed to this P2. They may hold off on a P3 until they get more data on the JCR ERT.

But I wonder if running the trial will take longer and then (if successful) getting patients to switch will be hard sell.


Longer than the monotherapy trial? It took them 3 years to complete that but it probably took that long because they were selective with the patient enrollment.

If the co-formulation efficacy is better and it's more convenient then perhaps getting patients to switch may not be a hard sell. However I am curious why GSK decided to give up US rights. Do they think that Amigal monotherapy is a small market?

I'm debating whether I should get back into FOLD. If only it had options.