Lubiprostone Successfully Completes Long-Term Phase 3 Safety Trial in Japanese Patients with Chronic Idiopathic Constipati

BETHESDA, Md. & ABBOTT PARK, Ill.--(BUSINESS WIRE)-- Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) and Abbott (NYSE:ABT) today announced positive top-line data from a 48-week phase 3 long-term safety and efficacy clinical trial of lubiprostone in Japanese patients with chronic idiopathic constipation (CIC). The trial demonstrated that lubiprostone was safe and well-tolerated.

This long-term phase 3 safety trial was an open-label, multi-center study in which Japanese CIC patients received one 24-mcg lubiprostone capsule twice a day for up to 48 weeks. A total of 209 patients were enrolled, 173 patients completed 24 weeks of treatment and 163 patients completed 48 weeks of treatment. The number of patients completing the full 48 week treatment period exceeded the target of 35 patients. Each enrolled patient had a history of fewer than three SBMs per week for at least six months, as confirmed during a 14-day screening period.

The safety results of the trial demonstrated that the most common adverse drug reactions (ADR) in this long-term safety trial were diarrhea (37.3%), nausea (27.3%), chest discomfort (7.2%) and abdominal pain (5.3%) which were transient in duration. The majority of first incidences of ADRs took place during the first two weeks of treatment. The most common mild ADRs were: diarrhea, nausea, chest discomfort, vomiting, abdominal pain, abdominal discomfort and abdominal distension. The most common moderate ADRs were diarrhea, nausea, vomiting and vertigo. There were no severe ADRs.

In February 2009, Sucampo entered into a license, commercialization, and supply agreement for lubiprostone with Abbott Japan Co. Ltd. under which Abbott received exclusive rights to commercialize lubiprostone in Japan for the treatment of CIC and the right of first refusal to any additional indications for which lubiprostone is developed in Japan. Sucampo continues to lead the development of and regulatory activity for lubiprostone in Japan.

Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and Chief Executive Officer of Sucampo Pharmaceuticals, Inc., said, “We are very pleased that these data are totally consistent with safety and efficacy data from previous phase 3 clinical trials of lubiprostone in the U.S. and Japan. We look forward to updating our recently submitted marketing application in early 2011 with Japan’s Pharmaceuticals and Medical Devices Agency with a full analysis of these data.”

Gary Winer, Vice President, Pharmaceuticals, Abbott Japan, said, “The long-term safety data for lubiprostone are encouraging and give us hope that Japanese patients suffering from CIC may soon have reason to expect relief from this difficult condition.”

Shin Fukudo, M.D. Ph.D., Professor of Behavioral Medicine at Tokohu University Graduate School of Medicine, in Sendai, Japan, said, “These results demonstrate that lubiprostone would be a useful drug for Japanese patients suffering from the life-altering effects of chronic idiopathic constipation.”

William D. Chey, Professor, Department of Internal Medicine, Director, Gastrointestinal Physiology Laboratory, and Director, Michigan Bowel Control Program, at the University of Michigan, said, “These data demonstrate the lubiprostone is a safe and effective treatment option for Japanese patients with CIC with or without IBS-C, and are consistent with previously reported pivotal phase 3 data for lubiprostone.”

Key efficacy highlights of the long-term safety trial results achieved by lubiprostone include:

1.

 

A statistically significant (p<0.001) increase from baseline in the number of spontaneous bowel movements (SBMs) at the end of Week 1 of treatment, an effect that was maintained at that level throughout the remainder of the treatment period;

2.

A statistically significant (p<0.001)increase from baseline in the number of rhythmic SBMs (rSBMs) at the end of Week 1 of treatment, an effect that continued at that level throughout the remainder of the treatment period;

3.

65.4% of patients experienced an SBM within 24 hours of their first dose;

4.

81.3% of patients experienced an SBM within 48 hours of their first dose;

5.

A statistically significant (p<0.001) decrease from baseline in the number of incomplete evacuations associated with an SBM at the end of Week 1, an effect that was maintained at that level throughout the treatment period;

6.

A statistically significant (p<0.001) improvement from baseline in stool consistency at the end of Week 1 of treatment, an effect that was maintained at that level throughout the remainder of the treatment period.

7.

A statistically significant (p<0.001) decrease from baseline in straining associated with an SBM at the end of Week 1, an effect that was maintained at that level throughout the treatment period;

8.

A statistically significant (p<0.01) decrease from baseline in bloating at the end of Week 1, an effect that increased in significance (p<0.001) at Week 3 and was maintained at that level throughout the remainder of the treatment period;

9.

A decrease from baseline in abdominal discomfort, an effect that became statistically significant (p<0.01) at Week 2 and increased in significance (p<0.001) at Week 3 and remained at that level throughout the remainder of the treatment period;

10.

A decrease from baseline in the number of days that “rescue” medications were used at the end of Week 1 that became statistically significant (p<0.01) at Week 2 and increased in significance at Week 3 (p<0.001) and was maintained at that level throughout the remainder of the treatment period;

11.

A statistically significant (p<0.01) improvement in four of the eight domains of the SF-36 (National Standard Value) patient self-assessment questionnaire. These four domains included physical function, body pain, general health perceptions and role emotional. The questionnaire was completed by patients at Baseline, Week 24 and Week 48.

12.

A statistically significant (p<0.001) improvement in all nine domains of the IBS-QOL-J patient self-assessment questionnaire. These domains included: dysphoria, interference with activity, body image, health worry, food avoidance; social reaction; sexual; relationships and total score. The questionnaire was completed by patients at Baseline, Week 24 and Week 48.

The data from this trial are undergoing further analysis and will be submitted to an appropriate medical conference for presentation.

Sucampo is developing lubiprostone in Japan as a potential treatment for patients with CIC. In September 2010, Sucampo submitted an application to the Japanese Pharmaceuticals and Medical Devices Agency for approval to market lubiprostone 24 mcg for the treatment of CIC. An update to that application, containing a full analysis of the data announced today, will be submitted in early 2011.

About the Phase 3 Efficacy Trial

Sucampo previously announced the top-line efficacy results from a pivotal phase 3 clinical trial of lubiprostone in Japanese CIC patients in which lubiprostone met its primary endpoint with statistical significance (p<0.001) and demonstrated a safety profile consistent with previously reported clinical trial data. The primary endpoint of the trial was a change in the number of spontaneous bowel movements (SBMs) at the end of the first week of treatment. This pivotal, double-blinded, placebo-controlled trial evaluated 124 Japanese CIC patients each of whom received one lubiprostone 24-mcg, or placebo, capsule twice daily for 28 days.

About Chronic Idiopathic Constipation

Constipation is characterized by infrequent and difficult passage of stool and becomes chronic when a patient suffers specified symptoms for over 12 non-consecutive weeks within a 12-month period. Chronic constipation is idiopathic if it is not caused by underlying diseases or by use of medications. Symptoms of chronic idiopathic constipation include straining, hard stools, bloating and abdominal pain or discomfort. Factors contributing to the development of CIC include a diet low in soluble and insoluble fiber, inadequate exercise, bowel disorders, and poor abdominal pressure and muscular weakness.

About Sucampo Pharmaceuticals

Sucampo Pharmaceuticals, Inc., an international biopharmaceutical company based in Bethesda, Maryland, focuses on the development and commercialization of medicines 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 about Sucampo Pharmaceuticals, please visit www.sucampo.com.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's Web site at www.abbott.com.

About Amitiza (lubiprostone) for Chronic Idiopathic Constipation and Irritable Bowel Syndrome with Constipation

Amitiza (lubiprostone) is 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.

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 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 distention (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 IBS-C, the most common adverse reactions (incidence >4%) were nausea (8% vs. 4%), diarrhea (7% vs. 4%), and abdominal pain (5% vs. 5%).

In clinical trials of Amitiza (24 mcg twice daily vs. placebo: N=1113 vs. N=316) in patients with CIC, Amitiza reached the primary endpoint of the change from baseline in the mean number of SBMs, with statistical significance. These data demonstrated that Amitiza increased the range of the number of spontaneous bowel movements (SBMs) in the treatment arms from 1.37 to 3.71-4.34 in Study SC0131 and 1.28 to 3.69-4.64 in Study SC0232, respectively. In the placebo arms of those studies, the range of SBMs went from 1.47 to 1.39-2.02 and from 1.52 to 1.85-2.47 in Study SC0131 and SC0232, respectively.

In clinical trials of Amitiza (8 mcg twice daily vs. placebo: N=1011 vs. N=435) in patients with IBS-C, Amitiza again met the primary endpoint, the percentage of overall responders in drug vs. placebo, with statistical significance. These data demonstrated that Amitiza-treated patients in Study 431 responded to treatment at a higher rate (13.8% vs. 7.8%) or 76% response rate over placebo rate. In Study 432, Amitiza-treated patients responded to treatment at a similarly high rate (12.1% vs. 5.7%) or 112% response rate over placebo rate. In trials designed to minimize the placebo effect, verum response rates were 76% and 112% over reported placebo rates in two separate, well-controlled, intent-to-treat pivotal trials. The trial designs were required by the FDA to minimize the placebo effect which is common in gastrointestinal studies and these particular treatment populations.

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

Amitiza® is a registered trademark of Sucampo Pharmaceuticals, Inc.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Sucampo Pharmaceuticals are forward-looking statements made under the provisions of The Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the words “project,” “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “should,” “would,” “could,” “will,” ”may” or other similar expressions. Forward-looking statements include statements about the potential utility of Amitiza to treat particular indications or conditions, including the potential utility of lubiprostone to treat chronic idiopathic constipation in Japanese patients, and future clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including those described in Sucampo Pharmaceuticals’ filings with the Securities and Exchange Commission (SEC), including the annual report on Form 10-K for the year ended December 31, 2009 and other periodic reports filed with the SEC. Any forward-looking statements in this press release represent Sucampo Pharmaceuticals’ views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Sucampo does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise, except as required by law.



CONTACT:

Sucampo Pharmaceuticals, Inc.
Kate de Santis, 240-223-3834
or
Westwicke Partners
John Woolford, 410-213-0506
or
Abbott
Alysa Hackett, 847-938-8446

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