Biotech Notebook: Medarex, Panacos, Advanced Life

Medarex(MEDX Quote) held a conference call Tuesday morning to discuss the results from the key trial of its skin cancer drug ipilimumab, and as with Monday's press release, the ratio of bamboozlement to hard facts was, unfortunately, off the charts.

For months now, on conference calls and at investor meetings, Medarex executives have sworn that there was no efficacy hurdle mandated by the Food and Drug Administration for its ipilimumab trials. But it seems clear from Monday's announcement and Tuesday's call that there was such a hurdle -- and Medarex tripped right over it.

The FDA wanted to see an ipilimumab response rate strong enough (probably in the mid-teens) to ensure that the lower bound of the confidence interval was above 10%. That was the primary endpoint of the phase III ipilumumab study in melanoma.

Medarex didn't get there. The company admits that fact. Therefore, the study failed.

Sounds like game over to me.

Yet, Medarex, on Tuesday's conference call, asked investors to disregard the failure of a pivotal trial. Instead, executives pointed everyone to the importance of the "totality of the data."

That's a catchphrase used so often by Medarex that it must be part of the company's mission statement or printed on the coffee cups in the corporate break room.

If you believe Medarex, this "totality of the data" is what the FDA has asked for and will use to review ipilimumab. It won't matter that the pivotal study failed, because all the other clinical data will convince regulators to approve the drug.

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