Sucampo, Takeda Begin Phase III Pediatric Constipation Trial

Sucampo and Takeda Initiate Global Pivotal Phase 3 Program of Lubiprostone in Pediatric Functional Constipation

BETHESDA, Md. and DEERFIELD, Ill., Dec. 17, 2013 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP) ("Sucampo") and its development and commercialization partner Takeda Pharmaceuticals ("Takeda") today announced the initiation of a global pivotal Phase 3 clinical program of lubiprostone in pediatric functional constipation. Functional constipation is a very common gastrointestinal complaint in children and is on the rise. An analysis of longitudinal data in the United States showed a nearly 4-fold increase in rates of constipation over the last decade.1

Lubiprostone is the world's first chloride channel activator that increases intestinal fluid secretion, softens stools and increases motility in the intestine, thereby facilitating the passage of stool and alleviating symptoms associated with chronic idiopathic constipation. This Phase 3 program was preceded by an open-label trial in 124 patients aged 3 to 17 years, which suggested that lubiprostone warrants further investigation as a potential treatment for children and adolescents with functional constipation.

Estimates of the prevalence rate of functional constipation in the pediatric population worldwide have varied from 4 to 37%.2 Only 50 to 70% of children with functional constipation demonstrate long-term improvement with the current treatments.3

"I am very pleased to be participating in this pivotal program which will study lubiprostone for pediatric functional constipation," said Paul Hyman, MD, Investigator and Professor of Pediatrics, Division Head, Gastroenterology, Children's Hospital at New Orleans, Louisiana State University Health Science Center. "There is an unmet need for alternatives to traditional laxative therapy in the pediatric population, and there are currently no prescription products indicated for long-term use in this population. We look forward to conducting this study to determine whether lubiprostone may be a valuable treatment alternative for these pediatric patients."

This Phase 3 program consists of two well-controlled pivotal studies with similar design -- one testing lubiprostone capsules in patients 6 to 17 years of age and another testing lubiprostone liquid formulation in patients aged 6 months to under 6 years. Sucampo also plans to evaluate the long-term safety of lubiprostone in these populations through two open-label extension studies.

The first Phase 3 trial in the program, which has just been initiated, is a randomized, placebo-controlled, double-blind study of the efficacy, safety and pharmacokinetics of lubiprostone in pediatric subjects between the ages of 6 to 17. The trial is expected to enroll more than 500 patients with pediatric functional constipation at up to
100 sites across the United States, Canada, and Europe. Subjects will be treated for 12 weeks with weight-based dosages of 12 mcg or 24 mcg twice daily (BID). The primary endpoint for this trial is overall spontaneous bowel movement (SBM) response. An SBM is a bowel movement that occurs without the use of another constipation treatment such as a laxative, enema, or suppository, during the 24 hours prior to occurrence.

Sucampo plans to file a supplemental new drug application with the U.S.
Food and Drug Administration following program completion, which is anticipated by early 2016.

About Pediatric Functional Constipation

The symptoms of pediatric functional constipation include infrequent bowel movements (BMs), hard stools, large diameter stools and painful passage of stools. Rome III diagnostic criteria for childhood functional constipation dictate that such symptoms occur at least once per week for at least 2 months prior to diagnosis. Children may also experience fecal retention due to withholding.1 There is a tendency to avoid defecation and withhold BMs as a result of pain experienced from the passage of large stools. This withholding of BMs can result in episodes of fecal incontinence. Ninety percent of pediatric constipation is functional constipation and it occurs in all age
groups.4

About lubiprostone

Amitiza(R) (lubiprostone) capsules are indicated for the treatment of chronic idiopathic constipation (CIC) in adults and opioid induced constipation (OIC) in adults with chronic, non-cancer pain (24 mcg twice daily). The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established.
Amitiza is also indicated for irritable bowel syndrome with constipation (IBS-C) in women > 18 years old (8 mcg twice daily).

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 (HCP) to confirm the absence of such an obstruction prior to initiating Amitiza treatment.

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 HCP.

Amitiza should not be prescribed to patients that have severe diarrhea.
Patients should be aware of the possible occurrence of diarrhea during treatment. Patients should be instructed to discontinue Amitiza and inform their HCP if severe diarrhea occurs.

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 HCP. Some patients have discontinued therapy because of dyspnea.

In clinical trials of Amitiza (24 mcg twice daily vs placebo; N=1113 vs N=316, respectively) in patients with CIC, the most common adverse reactions (incidence > 4%) were nausea (29% vs 3%), diarrhea (12% vs 1%), headache (11% vs 5%), abdominal pain (8% vs 3%), abdominal distension (6% vs 2%), and flatulence (6% vs 2%).

In clinical trials of Amitiza (24 mcg twice daily vs placebo; N=860 vs N=632, respectively) in patients with OIC, the most common adverse reactions (incidence > 4%) were nausea (11% vs 5%) and diarrhea (8% vs 2%).

In clinical trials of Amitiza (8 mcg twice daily vs placebo; N=1011 vs N=435, respectively) in patients with IBS-C the most common adverse reactions (incidence > 4%) were nausea (8% vs 4%), diarrhea (7% vs 4%), and abdominal pain (5% vs 5%).

Concomitant use of diphenylheptane opioids (e.g., methadone) may interfere with the efficacy of Amitiza.

The safety of Amitiza in pregnancy has not been evaluated in humans.
Based on animal data, Amitiza may cause fetal harm. Amitiza should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Amitiza is administered to a nursing woman. Advise nursing women to monitor infants for diarrhea.

Reduce the dosage in CIC and OIC patients with moderate and severe hepatic impairment. Reduce the dosage in IBS-C patients with severe hepatic impairment.

Please visit www.sucampo.com/products for complete Prescribing Information and for further information.

About Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc. is focused on the discovery, development and commercialization of drugs based on ion channel activators knows as prostones. Discovered by the company's scientific founder, prostones are naturally occurring fatty acid metabolites with unique physiological activities. Sucampo has two marketed products -- AMITIZA and RESCULA(R) -- and a pipeline of prostone-based product candidates in clinical development. A global company, Sucampo is headquartered in Bethesda, Maryland, and has operations in the United Kingdom, Switzerland and Japan. For more information, please visit www.sucampo.com.

The Sucampo logo and the tagline, The Science of Innovation, are registered trademarks of Sucampo AG. AMITIZA is a registered trademark of Sucampo AG. RESCULA is a registered trademark of R-Tech Ueno, Ltd, and has been licensed to Sucampo AG.

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Sucampo Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995.
These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, future financial and operating results, and other statements that are not historical facts. The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the impact of pharmaceutical industry regulation and health care legislation; Sucampo's ability to accurately predict future market conditions; dependence on the effectiveness of Sucampo's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Sucampo undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Forward-looking statements in this presentation should be evaluated together with the many uncertainties that affect Sucampo's business, particularly those mentioned in the risk factors and cautionary statements in Sucampo's most recent Form 8-K and 10-K, which Sucampo incorporates by reference.

About Takeda Pharmaceuticals U.S.A., Inc. and Takeda Development Center Americas, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., Inc. and Takeda Development Center Americas, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, gastroenterology and cardiovascular disease treatments and seek to bring innovative products to people through a pipeline that includes compounds in development for diabetes, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.takeda.us.

Takeda Forward-Looking Statement

This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda's plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as "may,"
"believe," "will," "expect," "project," "estimate," "should,"
"anticipate," "plan," "assume," "continue," "seek," "pro forma,"
"potential," "target," "forecast," "guidance," "outlook" or "intend" or other similar words or expressions of the negative thereof.
Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda's business, including general economic conditions in Japan, the United States and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof;
(6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.

The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda does update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections.

Sources:

1. Rajindrajith S. et al Constipation in Children: Novel Insight Into Epidemiology, Pathophysiology and Management. J Neurogastroenterol Motil 2011 January;17(1):35--47.

2. Loening-Baucke V. Prevalence rates for constipation and faecal and urinary incontinence. Arch Dis Child 2007 Jun;92(6):486-9.

3. Biggs WS. et al Evaluation and treatment of constipation in infants and children. Am Fam Physician 2006 Feb;73(3):469--77.

4. Mugie S. et al Constipation in childhood. Nature Reviews Gastroenterology and Hepatology 2011 Sept;8:502-511

CONTACT: Silvia Taylor
         Senior Vice President, IR, PR, and
         Corporate Communications
         1-240-223-3718
         staylor@sucampo.com

         Roseanne Durril
         Takeda Pharmaceuticals U.S.A., Inc.
         1-224-554-1474
         roseanne.durril@takeda.com
 

Posted: December 2013

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