Media Advisory: New Amitiza (lubiprostone) and Irritable Bowel Syndrome with Constipation Data Presented at the American College of Gastroenterology 2008 Annual Meeting Expands Breadth and Depth of State of the Science

What and When
 

New data on the efficacy of AMITIZA 8 mcg, twice daily, and impact of irritable bowel syndrome with constipation (IBS-C) on employment and cost figures will be presented in poster format at the American College of Gastroenterology 2008 Annual Scientific Meeting in Orlando, Florida:
 

  --  Influence of Responder Definition on Placebo Response: Insights Gained
      from Phase III Clinical Trials with Lubiprostone for IBS-C; Poster
      P645 presented on Monday, Oct. 6, from 10:30 a.m. to 4:00 p.m.
  --  Annual Direct and Indirect Cost of Illness in Employees with Irritable
      Bowel Syndrome plus Constipation; Poster P275 presented on Sunday,
      Oct. 5, from 3:30 p.m. to 7:00 p.m.
  --  The Prevalence and Costs to Treat Comorbidities in Persons with
      Constipation and Irritable Bowel Syndrome with Constipation in the 6
      Months After Diagnosis: An Employer Perspective; Poster P699 presented
      on Monday, Oct. 6, from 10:30 a.m. to 4:00 p.m.


To arrange an interview with Charles Baum, M.D., gastroenterologist, executive medical director, Gastroenterology and Internal Medicine, Takeda Pharmaceuticals North America, please contact Amy Losak at 646-935-3917.
 

About Irritable Bowel Syndrome with Constipation (IBS-C)
 

IBS is a disorder characterized by symptoms including 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 the last 3 months with symptom onset at least 6 months prior to diagnosis. 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-C is more prevalent in women as compared to men.
 

About AMITIZA(R) (lubiprostone) for Irritable Bowel Syndrome with Constipation
 

Indication
 

AMITIZA(R) (lubiprostone) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (8 mcg twice daily) 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 healthcare provider 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 healthcare provider.
 

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 healthcare provider 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 healthcare provider. Some patients have discontinued therapy because of dyspnea.
 

In clinical trials of AMITIZA (8 mcg twice daily vs placebo; N=1011 vs N=435) in patients with Irritable Bowel Syndrome with Constipation, the most common adverse reactions (incidence > 4%) were nausea (8% vs 4%), diarrhea (7% vs 4%), and abdominal pain (5% vs 5%).
 

  Please see complete Prescribing Information at www.amitiza.com.

  Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc., a 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 adult women greater than or equal to 18 years old, 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, U.K., 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 www.sucampo.com.
 

Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.
 

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, oncology, gastroenterology, neurology, rheumatology and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about these Takeda companies, visit www.tpna.com.
 

  Contact:
  Jocelyn M. Gerst
  Takeda Pharmaceuticals North America, Inc.
  224-554-5542 (office)
  jgerst@tpna.com

  Amy Losak, Ketchum
  646-935-3917 (office)
  917-865-6688 (cell)
  amy.losak@ketchum.com

  /PRNewswire - Oct. 6/

Source: Takeda Pharmaceuticals North America, Inc.

Web Site: http://www.tpna.com/
 

Posted: October 2008

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