Biotech Notebook: Medarex, Panacos, Advanced Life

Really? This FDA? The FDA that took a baseball bat to the knees of Genentech(DNA Quote) last week when it was trying to get Avastin approved for metastatic breast cancer? Avastin, one of the most successful and effective cancer drugs on the market, can't get a thumbs-up from an FDA advisory panel to treat terribly sick women with metastatic breast cancer, but Medarex is going to succeed with ipilumumab in melanoma using a failed study?

Hmmm. Good luck with that.

Everyone knows that melanoma patients lack good drugs to treat their cancer. And, of course, everything should be done to find and approve those drugs for them. But the FDA sets a very high bar for cancer drugs, and lately, it seems as if that bar has been raised.

The Medarex version of events when it comes to its dealings with FDA personnel seems a bit too fantastical to me. And the company clearly lacks the kind of jaw-dropping, unequivocal clinical data that prove ipilimumab's efficacy beyond any doubt.

So any FDA filing for ipilimumab is a Hail Mary pass. Those usually don't end well. Ipilimumab might one day be approved as a skin cancer treatment, but not on this go-around. That's been my call, and I'm sticking with it.

As for Medarex's stock, it's down 20% in Tuesday trading to $10.60. Medarex does have a pipeline of other drugs and some good partnerships. And there are enough believers in ipilimumab to counter the skeptics like myself. It's not hard to see this stock staying in the $8-$11 range.