SOURCE: Takeda Pharmaceuticals North America, Inc.

May 19, 2008 08:00 ET

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, CA--(Marketwire - May 19, 2008) - New study results indicated that treatment with AMITIZA® (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.

Additional data being presented at DDW

Abstract  Abstract Title                         Presentation
Number                                           Type/Date/Time

Clinical Data

157      What Symptoms Drive Global Symptom      Oral; Sunday,
         Improvement with Lubiprostone in        May 18, 2008 at
         Patients with Irritable Bowel           3:00pm PDT
         Syndrome and Constipation: Data from
         Two Multicenter, Randomized, Placebo-
         controlled Trials

S1272    Lubiprostone is Effective and Well      Poster; Sunday,
         Tolerated Through 48 Weeks of           May 18, 2008 from
         Treatment in Adults with                8am-5pm PDT;
         Irritable Bowel Syndrome and            Poster presentation
         Constipation                            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;
         Combined Analysis of Two Phase 3        Poster presentation
         Studies with Lubiprostone               from 12pm-2pm PDT

M1706    Discontinuation of Lubiprostone         Poster; Monday,
         Treatment for Irritable Bowel Syndrome  May 19, 2008 from
         with Constipation is Not Associated     8am-5pm PDT;
         with Symptom Increase or Recurrence:    Poster presentation
         Results from a randomized withdrawal    from 12pm-2pm PDT

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;
         population: Costs trends by category    Poster presentation
         in the 12 months after diagnosis from   from 12pm-2pm PDT
         1997 to 2002

808      Direct Medical Costs Associated with    Oral; Tuesday,
         Constipation from Childhood to Early    May 20, 2008 from
         Adulthood:  A Birth Cohort Study        4pm-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+,         May 20, 2008 from
         cAMP, 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,
         Action of Morphine on Mucosal           May 20, 2008 from
         Secretion in the Human Jejunum          4pm-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® (lubiprostone) for Chronic Idiopathic Constipation and IBS-C Indication

AMITIZA® (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 greater than or equal to 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® 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® (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