John Davis, writing on Friday for the InVivo "Deals of the Week" column, was absolutely spot-on -- in his analysis of the Lundbeck/Merck deal -- on Saphris®/Sycrest® (chemical name: asenapine):
. . . .With a large number of atypical antipsychotics competing for attention, any new entrant will have an uphill battle to gain traction. . . . [New Merck] has licensed to CNS-specialist H. Lundbeck exclusive commercialization rights to its recently approved Sycrest 
(asenapine) for all markets outside of the US, China and Japan. The Danish company paid an undisclosed upfront fee for the rights, and will also make product supply payments to the US company. Asenapine was launched in the US as Saphris by Merck last year, for schizophrenia and for mania associated with bipolar disorder, but has so far disappointed. Making matters trickier in the EU, the schizophrenia indication was turned down in there because regulators were not convinced of the agent's clinical effectiveness. . . .
Indeed -- much the same -- as we wrote,
on Tuesday, past.
John Davis, writing on Friday for the InVivo "Deals of the Week" column, was absolutely spot-on -- in his analysis of the Lundbeck/Merck deal -- on Saphris®/Sycrest® (chemical name: asenapine):
2 comments:
"Making matters trickier in the EU, the schizophrenia indication was turned down in there because regulators were not convinced of the agent's clinical effectiveness. . ."
This is not new information and has been discussed here many times.
Both the FDA clinical pharmacologist and the FDA statistician both said that there was not adequate evidence of efficacy for the schizophrenia indication. The clinical pharmacologist because the study was a 'failed study' as the positive control did not work and noncomparable patient populations, and the statistician because the same study wasn't adequately powered. (This was also reiterated by the Advisory Committee Statistician.).
Remember you heard it here first (15 months ago).
This of course does not even cover the problems with efficacy in bipolar (see Tuesday past and other SGP posts).
Salmon
Indeed. I completely agree.
Namaste
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