* New trial a ‘prudent approach’ to FDA approval process-CFO
* Pharming expects FDA regulatory process to start end-Feb
AMSTERDAM, Feb 22 (Reuters) - Dutch biotech Pharming (PHAR.AS) will start a new clinical trial into its drug Rhucin as it anticipates the U.S. Food and Drug and Administration will soon start the regulatory approval process for the product.
Pharming’s first product, being marketed as Ruconest in Europe and Rhucin in the United States where it is still awaiting regulatory approval, treats a rare and dangerous inflammation illness called hereditary angioedema (HAE).
In anticipation of a possible need for more clinical data, Pharming and its U.S. partner Santarus SNTS.O said on Tuesday they are starting a Phase IIIb clinical study to evaluate Rhucin, expecting to enrol 50 patients for a 12-18 month study.
“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 Chief Financial Chief Karl Keegan told Reuters.
“When we did the deal with Santarus, both teams decided it would be a prudent approach to run another trial ... and that if additional data would be required before approval, we would be in a good position to address it.”
“It’s not that it’s required, it is just a prudent approach to cover as many eventualities as possible.”
Pharming lodged its Biologics License Application (BLA) for Rhucin to the FDA in late December and the FDA has 60 days to accept the application, triggering the start of the regulatory approval process — a process which is likely extend into 2012.
Keegan said he expects the FDA to accept the BLA application by the end of the month, triggering a new $5 million milestone payment from Santarus.
Pharming is responsible for conducting and paying for the new clinical study. (Reporting by Aaron Gray-Block; Editing by Jon Loades-Carter)