Replies to post #76287 on Biotech Values

[iwfal]

For Provenge to be included in the NCCN compendium will require compelling efficacy data from at least a large phase-2 study.

I honestly have no idea what the standard here is. Would stat sig on P-11 "Time to Distant Mets" qualify? Randomized trial, earlier stage, but blind is broken already. Does it have to be the primary endpoint of the trial? Would Time to Distant Mets be a viable endpoint? ...

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[AlpineBV_Miller]

For Provenge to be included in the NCCN compendium will require compelling efficacy data from at least a large phase-2 study.

Correct. And even if one believes PROTECT is of sufficient size, it won't provide that answer on an allowable endpoint until well in to next decade.

Guys who want it off label could fork over the significant bucks for it, but I doubt that will be noticeable in the overall sales figures.

The first likely label "extension" won't technically be an extension but a mention of a positive relationship between Taxotere and Provenge (along the lines of the Petrylak retrospective data from 01/02a). A prospective trial designed in 2010 and launched in 2011 could get data by 2012 (or earlier if the Cougar trial validates the CTC marker). That would likely improve sales among oncologists. If adoption among urologists is heavy, however, even this 'extension' will also not be not very significant in terms of overall sales snce most guys will have had Provenge anyway by the time they get to the uro onc.

I should note that label extensions are not necessary to get Provenge to blockbuster status in North America, IMO of course.