Biotech Values

[DewDiligence]

Re: Boceprevir NDA timing

In #msg-50023809, I asked what had changed that MRK is now telling investors to expect a Boceprevir NDA submission in 2010 while Schering-Plough previously guided investors to expect a submission in 2011-2012 (#msg-33793554).

The answer appears to be that MRK intends to submit the NDA without the phase-3 trial that incorporates EPO and ribavirin dose reduction to manage anemia (defined as serum hemoglobin <=10 g/dL). The description of this trial is at: http://www.clinicaltrials.gov/ct2/show/NCT01023035 .

Schering-Plough had presumably planned to include this phase-3 trial as part of the NDA package; insofar as the entry in clinicaltrials.gov shows a completion date of Nov 2011, this explains Schering-Plough’s prior guidance of an NDA submission in 2011-2012.

The real question is whether MRK is genuinely expediting the Boceprevir timeline by submitting the NDA without the EPO trial. I.e., is MRK expediting the FDA review of Boceprevir or is it merely expediting the NDA submission? If the FDA will likely wait for the results of the EPO trial before ruling on Boceprevir, MRK’s expedited submission is a more of a cosmetic change than a substantive one.

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