Genentech's Avastin: Aftermath Of FDA Panel's "Thumbs Down"


My inbox is flooded this morning with research notes from analysts in the wake of yesterday's FDA panel meeting on Genentech's Avastin for breast cancer. The advisory committee voted 5-4 against recommending approval of the drug for that use.

The FDA usually follows the advice of its outside panels of experts, but in close votes like this one, it's not unheard of for the agency to go the other way.

In a scathing note to clients, Rodman & Renshaw biotech analyst Mike King is incredulous. He titles the note--and this is probably the most stinging research note title I've ever seen--"Panel Votes in Favor of Cancer Over Hypertension". He's referring to the side effect of high blood pressure. King calls the vote "inexplicable" and singles out the panel chair Dr. Maha Hussein--of Dendreon Provenge fame--for being "categorical in stating her opinion against approval based on unacceptable toxicity and lack of survival data." He also points out that three of the five people who voted against recommending approval were not doctors. I wonder if that will factor into the FDA's call. R & R may make a market in DNA .

Meantime, Cowen & Co. analyst Eric Schmidt is upgrading DNA to Outperform this morning on valuation since the stock has fallen 13 percent over the past few days. The FDA is expected to make a decision on Avastin for breast cancer next February.

And finally a postscript to my blog entry yesterday about Bristol's CEOpulling out of a CNBC interview at the company's analyst meeting because a spokesman said he had the flu. Not only did Jim Cornelius conduct the 30-minute opening presentation, he also handled the q and a session with analysts, the closing remarks and an impromptu little press conference with a small gaggle of reporters during the afternoon break--when he was supposed to be sitting down with me. Mr. Cornelius told the crowd his voice was "croaky," but it was still perfectly audible and strong.

Questions? Comments?