Sucampo Presents Detailed Results Of Positive Phase 3 Trial Of Lubiprostone In Opioid-Induced Bowel Dysfunction (OBD)

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced the presentation of positive data from a Phase 3 clinical trial of lubiprostone for the treatment of opioid-induced bowel dysfunction (OBD), at Digestive Disease Week 2012, held in San Diego, California . The Phase 3 trial evaluated lubiprostone for OBD in patients with chronic, non-cancer pain, excluding those taking methadone. As previously announced, in this study lubiprostone met its primary endpoint and was found to be safe and well-tolerated.

“We believe that these data demonstrate that lubiprostone may represent an important new treatment option for patients suffering from this condition,” said M. Mazen Jamal, M.D., M.P.H., a lead investigator in the trial and Chief of Endoscopy, Long Beach Veterans Affairs’ Medical Center, Long Beach, California, Professor, Department of Medicine, University of California College of Medicine at Irvine. Dr. Jamal gave the presentation, entitled “ Lubiprostone improves treatment response in opioid-induced bowel dysfunction patients with chronic, non-cancer pain: results from a Phase 3, randomized, double-blind, placebo-controlled clinical trial.”

Results from this trial not previously disclosed include:
  1. The proportion of patients with a first spontaneous bowel movement (SBM), at 4, 8, 12, 24 and 48 hours post-dose was found to be statistically significant over placebo (p=0.002, p=0.017, p=0.021, p=0.016 and p=0.022, respectively) with the median time to first SBM being 24.25 hours for those on lubiprostone versus 38.5 hours on placebo (p=0.019).
  2. Greater proportions of lubiprostone subjects experienced improvement in their OBD symptoms over the 12 week period than did placebo subjects, including: straining associated with SBMs (p=0.002), stool consistency of SBMs (p<0.001), constipation severity (p=0.007), abdominal bloating (p=0.208, not statistically significant) and abdominal discomfort (p=0.048).
  3. Weekly changes from baseline in SBM frequency (lubiprostone vs. placebo) were significantly different at 8 of the 12 treatment weeks for lubiprostone vs. placebo, with overall statistical significance achieved (p=0.005).

There were no drug-related serious adverse events reported for patients taking lubiprostone. Overall, the percentage of patients discontinuing treatment due to adverse events was 5.0% for the lubiprostone group compared with 1.8% in the placebo group. Of the patients receiving lubiprostone, 23.5% discontinued the study versus 18.6% of patients on placebo. The most common treatment-related adverse events (experienced by >5 percent of patients) were diarrhea (9.6% vs. 1.4%), nausea (8.2% vs. 2.7%), and abdominal pain (5.5% vs. 0.0%) for lubiprostone vs. placebo, respectively. A majority (91.7%) of lubiprostone patients who reported diarrhea described the events as mild to moderate in severity. The incidence rates of severe nausea were 1.4% for placebo-treated patients and 0.9% for lubiprostone treated patients.

About AMITIZA for Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C)

AMITIZA is a chloride channel activator indicated for the treatment of CIC (24 mcg twice daily) in adults and for IBS-C (8 mcg twice daily) in women 18 years of age and older.

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 (24 mcg twice daily vs. placebo; N=1113 vs. N=316) in patients with Chronic Idiopathic Constipation (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 (8 mcg twice daily vs. placebo; N=1011 vs. N=435) in patients with Irritable Bowel Syndrome with Constipation (IBS-C), the most common adverse reactions (incidence > 4%) were nausea (8% vs. 4%), diarrhea (7% vs. 4%), and abdominal pain (5% vs. 5%).

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

AMITIZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Based upon animal data lubiprostone may cause fetal harm.

For further information please see complete Prescribing Information and visit www.amitiza.com.

About Sucampo Pharmaceuticals

Sucampo Pharmaceuticals, Inc., an international pharmaceutical company is focused on the discovery, development and commercialization of proprietary drugs based on prostones. The therapeutic potential of prostones, which occur naturally in the human body as a result of enzymic (15-PGDH) transformation of certain fatty acids, 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 currently Advisor, International Business Development, and a member of the Board of Directors. For more information, please visit www.sucampo.com.

Sucampo Forward-Looking Statements

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 US 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 Form 10-K for the year ended Dec. 31, 2011, which the Company incorporates by reference.

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