GTCB
It looks like no-go in Europe unless the appeal works, which would seem to be a longshot.
The first stated reason for rejection—an insufficient number of patients—could presumably be rectified with data from the U.S. trial, but that trial is nearly two years from completion, so this is not an especially helpful solution.
The second stated reason for rejection—insufficient immunologic data—is surprising because GTC has stated that no one among the 200 or so individuals who have received ATryn in the various clinical trials has ever shown antibodies against the drug.
Finally, the third stated reason for rejection—insufficient testing with a new step in the filtration process—is one the requires clarification from the company.
CC at 9:00 a.m. ET.
It’s astonishing that the EMEA took two years to review the ATryn dossier and inspect GTC’s facilities but, even after all that time and effort, they are not satisfied that ATryn is safe and effective. It makes me wonder about the process.
With today’s bad news, I see an increased possibility of a buyout offer by Pharming. Obviously, such an offer would not be at the kind of deal price that would have been possible with marketing approval for ATryn. However, Pharming has some upcoming transgenics-based applications of its own that will be going before the EMEA and they may believe that ATryn would have a better shot on their watch. Even without ATryn, Pharming may think that GTC has sufficient assets (intellectual and physical) to warrant a deal.
In the short run, the possibility of a move from Pharming may be the only thing that puts a floor under the stock price. For now, I can’t even hazard a guess as to where the price will settle.
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