Much has been made about the welcomed increase in the number of FDA approved new drugs in 2011 -- up to 30 this year. Time for a hip-hip-hurrah no doubt. See Fierce Biotech.
I'm not so sure though if you worked for Dendreon (Provenge) or Human Genome Sciences (Benlysta). Both companies -- when the afterglow of approval waned -- experienced slower than forecasted sales. The result was that Dendreon's stock price plummeted more than 60% overnight when its Q3 earnings were released. The Company was forced to layoff more than 500 (mostly manufacturing) employees shortly thereafter. See Pharmalot and Seeking Alpha.
Much the same story has occured with HGS. It's sales have lagged -- only $25 million in Q4. It's stock price has suffered. It is now going to layoff more than 150 of its staff. So much for the first lupus drug in 50 years showing a quick sales takeoff. See Fierce Biotech.
Analysts and investors still remain cautiously optimistic that both treatments will catch on -- but the jury is out -- and it shows that the FDA is NOT the only obstacle to filling the coffers with geld when it comes to new drug approvals. You still have to pass muster with the subscribers and reimbursement community too.
Posted by Bruce Lehr Jan 10th 2012.
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