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mcbio

11/06/11 10:59 AM

#130377 RE: genisi #130366

Apropos to XP21279 the prodrug of L-dopa in Parkinson's, this is a recent PR related to GSK/IPXL competitive product - IPX066, regarding its second phase III trial, which I haven't seen mentioned here :

www.gsk.com/media/pressreleases/2011/2011-pressrelease-580727.htm

Thanks genisi. I had not heard of this competing agent from GSK/IPXL. Have you heard GSK give any buzz to their candidate in CCs? I would assume they would given these positive results and what I assume is a fairly large market opportunity.

Notwithstanding the big caveat in trying to compare data across trials between competing agents, I took a look at what I believe is XNPT's most recent results for their drug (http://phx.corporate-ir.net/phoenix.zhtml?c=187883&p=irol-newsArticle&ID=1475399&highlight= ) and tried to compare those to the GSK/IPXL results.

Aside from the usual caveats, I think it might be even more difficult to compare results because both trials utilized different controls. The XNPT trial utilized Sinemet as the control arm (L-Dopa/carbidopa) while the GSK/IPXL trial utilized L-Dopa/carbidopa plus entacapone. I think the latter control has more efficacy in Parkinson's patients so presumably the GSK/IPXL drug had a higher hurdle it was competing against. Primary endpoint for the GSK/IPXL drug was reduction in off time and results showed 3.8 hours of off time for the drug compared to 5.2 hours of off time for the control for a 1.4 hour reduction in favor of the GSK/IPXL drug. In XNPT's Phase 1b trial, XNPT's drug showed a reduction in off time of 2.9 hours compared to the control arm, so almost double that of the GSK/IPXL drug. But, again, I think the control in the GSK/IPXL drug was a higher hurdle to beat so, if the trials used the same control, presumably the numbers would be closer. Anyways, I assume this is a large enough market where there would be room for both competing agents. (XNPT clearly still has the burden of showing positive Phase 2 and Phase 3 results.)