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New AMITIZA 8 mcg Phase III Studies Demonstrated Overall Symptom Improvement in Adult Women with Irritable Bowel Syndrome with Constipation (IBS-C)

Additional Digestive Disease Week data highlight effects of AMITIZA in

patients with IBS-C

SAN DIEGO, May 18 /PRNewswire/ -- New study results indicated that treatment with AMITIZA(R) (lubiprostone) 8 mcg lead to significant relief of overall symptoms of Irritable Bowel Syndrome with Constipation (IBS-C). These results were presented at Digestive Disease Week (DDW) 2008, the largest annual international meeting of digestive disease specialists.

"IBS-C is a multi-symptom disorder and is one of the most common conditions seen by gastroenterologists," said William D. Chey, M.D., primary investigator of the study, University of Michigan Health System. "These data are important because they show that in studies, AMITIZA has demonstrated the ability to improve the overall symptoms reported by patients with IBS-C."

AMITIZA 8 mcg was approved by the U.S. Food and Drug Administration (FDA) on April 29, 2008 for the treatment of IBS-C in women 18 years of age and older, and has been approved since 2006 at a 24 mcg dose for the treatment of Chronic Idiopathic Constipation in adults. These data were among others presented at DDW 2008 that evaluated the effect of AMITIZA for IBS-C.

"AMITIZA is the first ClC-2 channel activator and the only widely available FDA-approved agent for the treatment of IBS-C in adult women in the United States. AMITIZA could provide overall symptom relief for the millions of appropriate patients in the U.S. who suffer from this condition," said Ryuji Ueno, M.D., Ph.D., Ph.D., founder, chairman and chief executive officer, Sucampo Pharmaceuticals (Nasdaq: SCMP). "We are pleased with the body of data on AMITIZA presented at DDW this year. Additional data presented at this meeting may help physicians better understand how to treat their patients with IBS-C."

"AMITIZA makes it possible for appropriate patients to receive a widely available FDA-approved treatment for their IBS-C," said Charles Baum, M.D., gastroenterologist and executive medical director, Gastroenterology and Internal Medicine, Takeda Pharmaceuticals North America, Inc.

Approximately 58 million Americans have Irritable Bowel Syndrome (IBS), and IBS-C accounts for approximately one-third of these cases. IBS-C is a chronic disorder characterized by abdominal discomfort or pain and changes in bowel habits including symptoms of constipation.

AMITIZA was developed by Sucampo Pharmaceuticals and is co-marketed in the U.S. by Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America.

About Irritable Bowel Syndrome with Constipation (IBS-C)

IBS is a disorder characterized by symptoms including recurrent abdominal discomfort or pain, bloating, and changes of bowel habits such as constipation and/or diarrhea. There are three main types of IBS: IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), and IBS with mixed constipation and diarrhea (IBS-M). In IBS-C, symptoms are present for at least 12 weeks (not necessarily consecutive) over a 12-month period. Although people with IBS-C report many of the symptoms associated with constipation, the presence of abdominal discomfort or pain is what differentiates IBS-C from chronic constipation. IBS is approximately two to two-and-a-half times more prevalent in women than men.

Abstract Presentation

Number Abstract Title Type/Date/Time

Clinical Data

157 What Symptoms Drive Global Symptom Oral; Sunday, May

Improvement with Lubiprostone in 18, 2008 at 3:00pm

Patients with Irritable Bowel Syndrome PDT

and Constipation: Data from Two

Multicenter, Randomized, Placebo-

controlled Trials

S1272 Lubiprostone is Effective and Well Poster; Sunday, May

Tolerated Through 48 Weeks of 18, 2008 from 8am-

Treatment in Adults with Irritable 5pm PDT; Poster

Bowel Syndrome and Constipation presentation from

12pm-2pm PDT

T1036 Health-Related Quality of Life in Poster; Tuesday,

Adults with Irritable Bowel Syndrome May 20, 2008 from

with Constipation: Results of a 8am-5pm PDT; Poster

Combined Analysis of Two Phase 3 presentation from

Studies with Lubiprostone 12pm-2pm PDT

M1706 Discontinuation of Lubiprostone Poster; Monday, May

Treatment for Irritable Bowel Syndrome 19, 2008 from 8am-

with Constipation is Not Associated 5pm PDT; Poster

with Symptom Increase or Recurrence: presentation from

Results from a randomized withdrawal 12pm-2pm PDT


Abstract Presentation

Number Abstract Title Type/Date/Time

Outcomes Data

T1029 Development of an Instrument to Assess Poster; Tuesday,

Treatment Satisfaction in Patients May 20, 2008 from

with Chronic Constipation 8am-5pm PDT; Poster

presentation from

12pm-2pm PDT

T1030 Similarities between Constipation with Poster; Tuesday,

and without Irritable Bowel Syndrome May 20, 2008 from

in a California Medicaid (Medi-Cal) 8am-5pm PDT; Poster

population: Costs trends by category presentation from

in the 12 months after diagnosis from 12pm-2pm PDT

1997 to 2002

808 Direct Medical Costs Associated with Oral; Tuesday, May

Constipation from Childhood to Early 20, 2008 from 4pm-

Adulthood: A Birth Cohort Study 5:30pm PDT;

Presentation from

4:30pm-4:45pm PDT

Pre-Clinical Data

T1876 Lubiprostone Activation of Cl- Poster; Tuesday,

Currents Does Not Involve Ca2+, cAMP, May 20, 2008 from

or PKA 8am-5pm PDT; Poster

presentation from

12pm-2pm PDT

T1877 ClC-2-Targeted siRNA Eliminates Poster; Tuesday,

Lubiprostone Activation of Cl- May 20, 2008 from

Currents in T84 Cells 8am-5pm PDT; Poster

presentation from

12pm-2pm PDT

T1081 Effect of Lubiprostone on Duodenal Poster; Tuesday,

Mucosal Bicarbonate Secretion May 20, 2008 from

8am-5pm PDT; Poster

presentation from

12pm-2pm PDT

844 Lubiprostone Reverses the Inhibitory Oral; Tuesday, May

Action of Morphine on Mucosal 20, 2008 from 4pm-

Secretion in the Human Jejunum 5:30pm PDT;

Presentation from

4:45pm-5pm PDT

T1380 Lubiprostone Enhances Histamine H2 Poster; Tuesday,

Receptor-Mediated Cyclical Chloride May 20, 2008 from

Secretion in the Guinea Pig Colon 8am-5pm PDT; Poster

presentation from

12pm-2pm PDT

About AMITIZA(R) (lubiprostone) for Chronic Idiopathic Constipation and IBS-C Indication

AMITIZA(R) (lubiprostone) is indicated for the treatment of Chronic Idiopathic Constipation (24 mcg) in adults and for Irritable Bowel Syndrome with Constipation (8 mcg) in women > 18 years old.

Important Safety Information

AMITIZA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating physician to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.

The safety of AMITIZA in pregnancy has not been evaluated in humans. AMITIZA should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures.

Patients taking AMITIZA may experience nausea. If this occurs, concomitant administration of food with AMITIZA may reduce symptoms of nausea. Patients who experience severe nausea should inform their physician.

AMITIZA should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment and inform their physician if the diarrhea becomes severe.

Patients taking AMITIZA may experience dyspnea within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their physician.

In clinical trials of AMITIZA (24 mcg) in patients with Chronic Idiopathic Constipation, the most common adverse reactions (incidence > 4%) were nausea (29%), diarrhea (12%), headache (11%), abdominal pain (8%), abdominal distention (6%), and flatulence (6%).

In clinical trials of AMITIZA (8 mcg) in patients with Irritable Bowel Syndrome with Constipation, the most common adverse reactions (incidence > 4%) were nausea (8%), diarrhea (7%), and abdominal pain (5%).

Please see complete Prescribing Information at

AMITIZA is co-marketed by Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc.

AMITIZA(R) is a registered trademark of Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc., a specialty biopharmaceutical company based in Bethesda, Md., focuses on the development and commercialization of medicines based on prostones. The therapeutic potential of prostones, which are bio-lipids that occur naturally in the human body, was first identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals' chairman and chief executive officer. Dr. Ueno founded Sucampo Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding chief executive officer and advisor, international business development.

Sucampo Pharmaceuticals is marketing AMITIZA(R) (lubiprostone) in the U.S. for Chronic Idiopathic Constipation in adults and Irritable Bowel Syndrome with Constipation in women 18 years of age and older and is developing the drug for additional gastrointestinal disorders with large potential markets. In addition, Sucampo Pharmaceuticals has a robust pipeline of compounds with the potential to target underserved diseases affecting millions of patients worldwide. Sucampo Pharmaceuticals has two wholly-owned subsidiaries: Sucampo Pharma Europe, Ltd., headquartered in Oxford, UK with a branch office in Basel, Switzerland, and Sucampo Pharma, Ltd., located in Tokyo and Osaka, Japan. To learn more about Sucampo Pharmaceuticals and its products, visit

Takeda Pharmaceuticals North America, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, TPNA currently markets products for diabetes, insomnia, wakefulness and gastroenterology. The company has a robust pipeline with compounds in development for diabetes, cardiovascular disease and other conditions. TPNA is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about the company and its products, visit

About Digestive Disease Week (DDW)

DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the

Alimentary Tract, DDW takes place May 17-22, 2008, at the San Diego Convention Center, San Diego, CA. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit

SOURCE Takeda Pharmaceuticals North America, Inc.; SucampoPharmaceuticals,
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