BETHESDA, Md. & ABBOTT PARK, Ill.--(BUSINESS WIRE)-- Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) and Abbott (NYSE:ABT) today announced that a pivotal phase 3 clinical trial of lubiprostone for chronic idiopathic constipation (CIC) in Japanese patients met its primary endpoint with statistical significance and demonstrated a safety profile consistent with previously reported clinical lubiprostone data.
The primary endpoint of this 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.
As previously reported, Sucampo continues to conduct a long-term, open-label, multi-center, confirmatory, safety trial in 209 Japanese CIC patients. Top-line results from the safety trial are expected during the fourth quarter of 2010.
“While lubiprostone has been demonstrated to be effective in other ethnic populations, this is the first phase 3 study demonstrating that lubiprostone is effective in improving the signs and symptoms of chronic idiopathic constipation specifically in Japanese patients. As such, it is a milestone in Sucampo’s long-term growth strategy to secure international approvals,” said Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo’s Chairman and Chief Executive Officer.
"The results of the lubiprostone trial are very encouraging for Japanese patients suffering from this condition, and the product will be a major breakthrough in improving the quality of life for CIC patients," said Gary M. Winer, President, Abbott Japan, which holds commercialization rights to lubiprostone in Japan.
Sucampo is developing lubiprostone in Japan as a potential treatment for patients with chronic idiopathic constipation (CIC). 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.
Lubiprostone (trade named Amitiza™) is a local activator of type-2 chloride channels in cells lining the small intestine. Lubiprostone increases fluid secretion into the intestinal tract. This increased fluid level softens the stool, facilitating intestinal motility and bowel movements. We believe the type 2 chloride channels also play an important role in the restoration of tight junction complexes and in the recovery of barrier function in the body.
Amitiza is a registered trademark of Sucampo Pharmaceuticals, Inc.
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 other 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 chronic idiopathic constipation 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 by 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.
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 approximately 83,000 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.
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. 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, 2008 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 data. 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.
Sucampo Pharmaceuticals, Inc.
Kate de Santis
KEYWORDS: United States Asia Pacific North America Illinois Maryland Japan
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Pharmaceutical Research Consumer Asian-American Science