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FDA Accepts Sucampo's sNDA for Lubiprostone (8 mcg) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C)
Date:9/17/2007

Lower Strength of Approved Constipation Drug Offers Potential Treatment

Option to Americans Suffering from IBS-C

BETHESDA, Md., Sept. 17 /PRNewswire-FirstCall/ -- Sucampo Pharmaceuticals, Inc., (Nasdaq: SCMP) today announced that the supplemental New Drug Application (sNDA) for lubiprostone (8 mcg, oral gel capsules, twice daily) for the treatment of irritable bowel syndrome with constipation (IBS-C) has been accepted for review by the U.S. Food and Drug Administration (FDA). Sucampo Pharmaceuticals currently anticipates a decision from the FDA in the second quarter of 2008.

Lubiprostone, a chloride channel activator with a novel mechanism of action, was developed by Sucampo Pharmaceuticals. The 24-mcg formulation of the drug (AMITIZA(R)) is approved for the treatment of Chronic Idiopathic Constipation in adults and is marketed for this indication in the United States by Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America, Inc.

"The FDA's decision to accept our sNDA submission for review is an important step in filling an unmet medical need for patients with the debilitating disease of IBS-C," said Ryuji Ueno, M.D., Ph.D., Ph.D., founder, chairman and chief executive officer of Sucampo Pharmaceuticals. "IBS-C has a significant impact on millions of Americans and, if approved, lubiprostone may offer a valuable new treatment option for people living with this condition."

Approximately 58 million Americans have irritable bowel syndrome (IBS), with IBS-C accounting for approximately one-third of these cases. IBS-C symptoms include abdominal pain and discomfort associated with defecation or a change in bowel habits with features of disordered defecation.

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