Sucampo Pharma Europe Receives Validation of Marketing Authorization Applications
2008-05-15 23:52:56 -
- Sucampo Pharmaceuticals, Inc. Mariam Morris, +01-301-961-3400 Chief Financial Officer Fax: +01-301-961-3440 mmorris@sucampo.com Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that its wholly-owned European subsidiary, Sucampo Pharma Europe Ltd., received notice that all of the Marketing Authorization Applications (MAA) for lubiprostone, 24 mcg, (AMITIZA(R)) for the indication of Chronic Idiopathic Constipation in adults have been received and validated by the individual regulatory agencies in Belgium, Denmark, France, Germany, Ireland, the Netherlands, Spain, Sweden and the United Kingdom. The applications were submitted using the decentralized process with the United Kingdom serving as the reference member state. With the validation, the agencies will begin their formal review of the applications.
AMITIZA, developed by Sucampo Pharmaceuticals, is an established therapy for Chronic Idiopathic Constipation in adults in the United States. AMITIZA, 24 mcg, received U.S. Food and Drug Administration (FDA) approval in January 2006 and has been available in the United States for Chronic Idiopathic Constipation in adults since April 2006. In April 2008, AMITIZA(R) 8 mcg was approved by the FDA for Irritable Bowel Syndrome with Constipation in adult women 18 years of age and older. It is the only approved prescription product for this indication in the United States.
"The validation of our applications and initiation of the review process moves us one step closer to achieving our goal of international expansion," said Ryuji Ueno, M.D., Ph.D., Ph.D., founder, chairman and chief executive officer of Sucampo Pharmaceuticals. "We will work closely with these regulatory agencies over the coming months to address their questions during the review and approval process."
These applications represent the first major marketing authorization effort for Sucampo Pharmaceuticals outside the United States. Sucampo Pharmaceuticals continues to review marketing opportunities in other parts of the world in order to build upon the current success of AMITIZA(R) in the United States.
About AMITIZA(R) (lubiprostone)
AMITIZA(R) (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%).
For full prescribing information, visit www.amitiza.com.
About Sucampo Pharma Europe, Ltd.
Sucampo Pharma Europe, Ltd., a wholly-owned subsidiary of Sucampo Pharmaceuticals, Inc., is a specialty biopharmaceutical company based in Oxford, United Kingdom, with a branch office in Basel, Switzerland. The European operations are focused on developing, commercializing and marketing of AMITIZA(R) (lubiprostone) within Europe, the Middle East, and Africa and developing other pipeline products based upon prostone technology. To learn more about Sucampo Pharma Europe, Ltd., visit www.sucampoeurope.com.
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(R) (lubiprostone) 24 mcg in the U.S. for Chronic Idiopathic Constipation in adults and is developing the drug for additional gastrointestinal disorders with large potential markets. AMITIZA 8 mcg was recently approved by the FDA to treat Irritable Bowel Syndrome with Constipation in adult women 18 years of age and older. In addition, Sucampo Pharmaceuticals has a robust pipeline of compounds with the potential to target underserved diseases affecting millions of patients worldwide. Sucampo Pharmaceuticals has two wholly-owned subsidiaries: Sucampo Pharma Europe, Ltd., headquartered in Oxford, UK 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.
AMITIZA(R) 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, 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. 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.
European Agencies Now Initiate the Review of Lubiprostone for
Chronic Idiopathic Constipation in Adults
