Repligen Corporation (RGEN) Seeks Approval for Imaging Product While Pursuing Rare-Disease Drugs and Manufacturing Platform
9/2/2011 7:43:46 AM
Patients who arrive in the emergency room complaining of abdominal pain often have to undergo a type of endoscopy—an invasive and sometimes dangerous test— so doctors can determine if the problem is in the pancreas. Taking an MRI scan is a safer alternative, but the resulting images often aren’t sharp enough to make a proper diagnosis. Enter Repligen (NASDAQ: RGEN). The Waltham, MA-based company is in the final stages of applying for FDA approval for synthetic human secretin (SecreFlo), a hormone-based drug that’s designed to enhance MRI images of the pancreas. The FDA has granted the product fast-track status, meaning it has vowed to hand Repligen its verdict within six months of receiving the application. Even though Repligen is pursuing other opportunities, CEO Walter Herlihy is counting on the imaging product to boost Repligen’s profile as a commercial player. “The hormone is very specific for the pancreas, and that opens up the potential for exciting applications,” Herlihy says.