With its experimental drug Rhucin up for review at the FDA, Pharming says it will mount a Phase IIIb study in anticipation that a tough crowd at the FDA will ask for more data than what it has already submitted for the treatment of hereditary angioedema.
"Our approach is that our studies are sufficient. But if you wait till the FDA comes back to you (with more questions), you have to wait another year to 18 months," Pharming CFO Karl Keegan told Reuters. "It's not that it's required, it is just a prudent approach to cover as many eventualities as possible."
Pharming and its partner Santarus say they plan to enroll about 50 patients in the new study, which should run 12 to 18 months. Keegan says he expects that their regulatory application will be accepted for review in a matter of days, setting up a regulatory process that is likely to stretch into 2012. And if regulators come back with more questions--a common issue these days--the two biotechs plan to be ready with some quick answers.
San Diego-based Santarus has licensed certain exclusive rights from Pharming to commercialize Rhucin in North America. The drug is made with the help of transgenic rabbits. Under the terms of the license agreement, Pharming is responsible for conducting and paying for the current clinical study with Rhucin in the treatment of acute attacks of angioedema.
- check out the Pharming release
- here's the story from Reuters