The FDA managed to rattle ThromboGenics' investors yesterday with a warning on the adverse events associated with its eye drug ocriplasmin. With an expert panel review looming tomorrow, the regulatory review cited several serious adverse events, sending the biotech's shares down as much as 19%.
ThromboGenics' management, though, didn't budge. Everything in the FDA report, the Belgian biotech said, is well known to them. The adverse events are generally transient and easily dealt with, and they sounded confident that they could answer any of the experts' pointed questions about safety.
"We have evidence that these things are all transient. There is nothing that is really sustained. Of course, we will address this during the discussion," ThromboGenics CFO Chris Buyse told Reuters. "We are well prepared and we are very confident that this drug will be approved, hopefully after positive advice on Thursday."
Just last March Novartis' ($NVS) Alcon unit paid $99 million upfront and promised close to $400 million more in milestones to gain the rights to commercialize the drug outside of the the U.S. Ocriplasmin is designed to treat an eye ailment known as symptomatic vitreomacular adhesion, or VMA.
The FDA largely conceded the point on transience, but raised a question on just how effectively ThromboGenics' data package addresses the issue.
"These adverse events may be transient and cause no long term harm to the retina," the FDA noted. "However, this conclusion can not be made definitively based on the data available."
Analysts noted that it's not unusual for the FDA to take a sharp tone in its reviews of experimental meds. The purpose of these panels is to zero in on any weak spots in the application, giving regulators and developers a chance to explore any issues that could trigger a delay or rejection.
- here's the Reuters story
- get the Bloomberg report