As you've no doubt heard, Imclone issued a press release this morning about their FDA meeting. It seems that if they can come up with more clinical data from Merck KGaA's European trials, along with clarifying some of their own numbers, then the FDA has agreed to look at a resubmission. Bristol Meyers-Squibb has been notable for their complete silence so far, which doesn't make them look very enthusiastic.
And as you've no doubt calculated, my short sale of Imclone's stock yesterday did not turn out to be very lucrative. Nor will it be, most likely. But I'm keeping the position for now, looking to escape fairly soon without too much financial damage. This FDA news, while not the worst that could have happened for the drug's development, isn't all that good, either.
The European data won't be available until the end of the year, even if all goes well. That trial is still in the enrollment phase, and it looks like Germany's Merck is being very careful about which patients go in (caution made even more important by the FDA's reaction to Imclone's data.)
That brings the drug to market a year late - again, if everything works like it's supposed to. That's bad news for the cancer patient population, because the patients who would benefit most immediately from the drug may not be around in another year to take it. And it's bad news for Imclone and BMS, too, because competing therapies aimed at the same molecular target (the epidermal growth factor receptor) are coming along. Some of these aren't antibodies, like Imclone's candidate - they're small drug molecules. If those work, they'll be easier and cheaper to produce in quantity. If they don't set off too many side effects, they could be real competition.
Who to blame for all this? The Wall St. Journal weighs in with another Imclone editorial (no free link,) as they did back on Feb. 13th. I'd been kicking around the idea of commenting that one out paragraph by paragraph, and now I'm already behind.
They came down hard on the FDA both times, suggesting that the government changed the requirements in mid-stream, and that the efficacy standards are too stringent. As odd as it feels for a pharma researcher, I have to come to the FDA's defense here. It was Imclone's (and, let's not forget, BMS's) responsibility to make sure that the clinical data were ready for approval. Arguing about what the FDA should be is beside the point: every drug company knows what the FDA is.
And every large drug company knows what sorts of submissions have a more solid chance of being approved. Imclone chose to do the shortest, smallest trial they possibly could get away with, and it backfired on them. One reason for that trial design was to be able treat cancer patients more quickly - that's a huge motivating factor for everyone in the field, and I don't want to minimize it. But another reason for Imclone's hurry is the hoofbeats that they can hear coming up behind them. They need this drug to be first to market. Bristol-Meyers Squibb, for their part, is already on the hook for two billion dollars for only 40% of the drug's profits. And every delay decreases their chances of ever earning that money back.