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Enrollment Complete for Phase III Study of <br>SPI-0211, Treatment for Constipation

BETHESDA, MD -- September 8, 2003 -- Sucampo Pharmaceuticals, Inc., a leader in functional fatty acid research and development, announced today it has completed enrollment for the last of two Phase III efficacy studies to support the New Drug Application (NDA) for its proprietary chloride channel activator, SPI-0211, in treating constipation. The Sucampo trial randomized 237 patients with documented constipation into two treatment groups at 20 sites throughout the United States. Study participation is expected to be completed in October 2003.

Results from the first phase III efficacy study for the treatment of constipation using SPI-0211 was presented in May of this year at the Digestive Disease Week 2003 Conference in Orlando. During the presentation there, John F. Johanson, M.D., MSc, Rockford Gastroenterology Associates, told an audience that the agent, at a dose of 24 micrograms twice daily, performed significantly better than placebo for all constipation variables tested.

"Constipation is a common and bothersome gastrointestinal condition affecting an estimated 5 million Americans,"said Sucampo CEO Myra L. Patchen, Ph.D. "Current treatment options are often poorly tolerated or ineffective. We believe this study will again demonstrate that SPI-0211 is a highly effective and safe treatment for this condition."

Constipation is defined as infrequent and difficult passage of stool. In the United States, nearly 2.5 million physician visits per year are due to bouts of constipation. According to IMS Health, the constipation market exceeded $550 million in 2002.

The company announced in late April 2003 that it had initiated a Phase II multi-center, safety and efficacy study for the treatment of constipation-predominant irritable bowel syndrome (IBS) with SPI-0211. It also submitted an IND to the U.S. Food and Drug Administration for SPI-0211 in treating postoperative ileus in May.

Dr. Ryuji Ueno and Dr. Sachiko Kuno founded Sucampo Pharmaceuticals in 1996 as the U.S. operating company of the global Sucampo Group. The Group's first product, Rescula®, a glaucoma medication, is marketed in more than 45 countries worldwide.

Source: Sucampo Pharmaceuticals, Inc.

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