Orphan drug designation qualifies Repligen for seven years of exclusive marketing rights in the US. The designation also provides for benefit from certain tax credits and waives the company's obligation to pay the FDA application user fees.
Repligen is currently conducting a phase II/III clinical trial of RG1068 as an agent to improve the detection of structural abnormalities of the pancreatic ducts during magnetic resonance imaging (MRI) imaging of the pancreas. A phase I investigator study to assess the utility of secretin for functional imaging of the pancreas is also currently underway.
“We believe there may be more than 100,000 pancreatic MRI's in the US each year that could benefit from the use of secretin,” said Walter Herlihy, president and CEO of Repligen.
Secretin is a natural gastrointestinal hormone involved in the process of digestion. Secretin has been used for many years in combination with endoscopy, an invasive procedure to evaluate and treat diseases of the pancreas and gallbladder. There are risks associated with the use of endoscopy, which have generated interest in the development of safer non-invasive tests such as MRI scans to diagnose gastrointestinal disorders.