Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that its wholly owned subsidiary, Sucampo Pharma Europe, Ltd. (SPE), filed a Marketing Authorization Application (MAA) in Switzerland for AMITIZA (lubiprostone) for the indication of Chronic Idiopathic Constipation in adults. The MAA was filed with Swissmedic by Sucampo Pharmaceuticals´ branch office in Basel, Switzerland.
The submission is part of the ongoing development of AMITIZA 24 mcg which was first launched in the United States in April 2006 for the treatment of Chronic Idiopathic Constipation in adults. In May 2008, AMITIZA 8 mcg was launched for the treatment of Irritable Bowel Syndrome with Constipation in adult women. Earlier this year, MAAs were filed in nine European countries for Chronic Idiopathic Constipation in adults at 24 mcg and are currently under review.
"Building upon the success of AMITIZA in the United States, we are systematically developing additional marketing opportunities outside the United States. This application is a continuation of these efforts as well as an ongoing expansion of our European operations," said Ryuji Ueno, M.D., Ph.D., Ph.D., founder, chairman and chief executive officer, Sucampo Pharmaceuticals.
In the United States, AMITIZA is the only FDA–approved prescription treatment option for both Chronic Idiopathic Constipation in adults and Irritable Bowel Syndrome with Constipation in adult women. Other than the United States and Canada, Sucampo Pharmaceuticals retains all commercial rights for AMITIZA (lubiprostone) in Europe and the rest of the world. AMITIZA (lubiprostone) was a 2006 Scrip Awards finalist for the "Best New Small–Molecule Drug" category.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., a specialty 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 women 18 years of age and older, 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 unmet medical conditions 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.
About Sucampo Pharma Europe, Ltd.
Sucampo Pharma Europe, Ltd., a wholly owned subsidiary of Sucampo Pharmaceuticals, is a specialty biopharmaceutical company based in Oxford, United Kingdom with a branch office in Basel, Switzerland. The European operations are focused on the development, commercializing and marketing of AMITIZA (lubiprostone) within Europe, the Middle East, and Africa as well as the development of other pipeline products based upon prostone technology and were established in 2002 as part of an ongoing establishment of Sucampo Pharmaceuticals, Inc. as an international company in research and development of its prostone technology. To learn more about Sucampo Pharma Europe, Ltd., visit www.sucampoeurope.com.
About AMITIZA® (lubiprostone) for Chronic Idiopathic Constipation and Irritable Bowel Syndrome with Constipation
AMITIZA (lubiprostone) is indicated for the treatment of Chronic Idiopathic Constipation (24 mcg) in adults and for Irritable Bowel Syndrome with Constipation (8 mcg) 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 physician 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 physician.
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 physician 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 physician.
In clinical trials of AMITIZA (24 mcg) in patients with Chronic Idiopathic Constipation, the most common adverse reactions (incidence > 4%) were nausea (29%), diarrhea (12%), headache (11%), abdominal pain (8%), abdominal distention (6%), and flatulence (6%).
In clinical trials of AMITIZA (8 mcg) in patients with Irritable Bowel Syndrome with Constipation, the most common adverse reactions (incidence > 4%) were nausea (8%), diarrhea (7%), and abdominal pain (5%).
Please see complete Prescribing Information at www.amitiza.com.
Forward–Looking Statements
Any statements in this press release about future expectations, plans and prospects for Sucampo Pharmaceuticals, Inc. 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. Actual results may differ materially from those indicated by such forward–looking statements as a result of various important factors, including risks relating to: the results of clinical trials with respect to Sucampo Pharmaceuticals´ products under development; the timing and success of submission, acceptance and approval of regulatory filings; Sucampo Pharmaceuticals´ dependence on the commercial success of AMITIZA; Sucampo Pharmaceuticals´ ability to obtain additional funding required to conduct its discovery, development and commercialization programs; Sucampo Pharmaceuticals´ dependence on its co–marketing alliance with Takeda Pharmaceutical Company Limited; and Sucampo Pharmaceuticals´ ability to obtain, maintain and enforce patent and other intellectual property protection for its discoveries. These and other risks are described in greater detail in the "Risk Factors" section of Sucampo Pharmaceuticals´ Annual Report on Form 10–K filed with the Securities and Exchange Commission for the fiscal year ended December 31, 2007 and its Quarterly Reports on Form 10–Q filed subsequently. 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 Pharmaceuticals anticipates that subsequent events and developments will cause its views to change. However, while Sucampo Pharmaceuticals may elect to update these forward–looking statements publicly at some point in the future, it specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise.
AMITIZA® is a registered trademark of Sucampo Pharmaceuticals, Inc.
