Sucampo's lead drug, Amitza, was approved by the FDA for chronic idiopathic constipation in 2006 and irritable bowel syndrome and constipation in 2008. It has been prescribed to 6 million patients. Still the company flies under the radar for many analysts. This may be a breakout year for the Bethesda, MD, company, which has gotten approvals in Japan and the U.K. and is looking for a new indication in the U.S. While 2013 may be a challenge for the industry in general, Sucampo Pharma Americas President Stan Miele says, "All organizations are looking for novel ways to market, but in the end, if you have a product with a novel mechanism and are serving patients with unmet medical needs, there is always a place for a product to be successful."