Healthcare Industry News: chronic idiopathic constipation
News Release - February 27, 2008
Sucampo Pharma Europe Announces the Filing of a Marketing Authorisation Application of Lubiprostone in the United Kingdom with Eight Additional European Countries to Follow
OXFORD, United Kingdom--(HSMN NewsFeed)--Sucampo Pharma Europe, Ltd., a wholly-owned subsidiary of Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP ), today announced the filing of a Marketing Authorisation Application (MAA) for lubiprostone in the United Kingdom. The MAA is for lubiprostone, 24 mcg, for the indication of chronic idiopathic constipation in adults. Lubiprostone was previously developed by Sucampo Pharmaceuticals, Inc. for the treatment of chronic idiopathic constipation in adults in the United States.Using the decentralised procedure, the United Kingdom, through its Medicines and Healthcare Products Regulatory Agency, will serve as the reference member state with additional applications being filed with the concerned member states of Belgium, Denmark, France, Germany, Ireland, the Netherlands, Spain and Sweden.
Individuals with chronic idiopathic constipation are distinguished as having abdominal bloating, infrequent bowel movement, straining at defecation, hard or lumpy stools for at least three months and not having these symptoms caused by other diseases or medication usage. Lubiprostone, 24 mcg, approved in the United States in January 2006 under the trade name AMITIZA® is the only approved product for the treatment of chronic idiopathic constipation in adults in the United States, and has been shown in clinical studies to provide a rapid and sustained relief of chronic idiopathic constipation and the associated symptoms. Lubiprostone, through a novel mechanism of action, selectively activates type-2 chloride channels in the intestinal lumen, which facilitates intestinal fluid secretion that enhances intestinal motility and passage of stool. Additionally, lubiprostone has been shown in ex-vivo studies by the activation of chloride channels to stimulate recovery of mucosal barrier function through the restoration of tight junction complexes. Lubiprostone has demonstrated long-term safety and efficacy for treatment of chronic idiopathic constipation for up to one year. Furthermore, lubiprostone demonstrated efficacy in all adults of both genders including those over 65 years of age.
“The lack of effective prescription products for this indication provides a unique opportunity for Sucampo to introduce lubiprostone to Europe as a treatment for chronic idiopathic constipation,” said Sucampo Pharmaceuticals Chairman and Chief Executive Officer Ryuji Ueno, M.D., Ph.D., Ph.D. “The filing of the application for lubiprostone represents one step in Sucampo’s planned expansion for this compound to the international community.”
Other than the United States and Canada, Sucampo Pharmaceuticals retains all commercial rights for lubiprostone for Europe and the rest of the world. Sucampo Pharmaceuticals’ drug AMITIZA® (lubiprostone) was a 2006 Scrip Awards finalist for the “Best New Small-Molecule Drug” category.
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 operation is focused on developing, commercialising and marketing AMITIZA® (lubiprostone) within Europe, the Middle East, and Africa as well as the development of other pipeline products based upon 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 along with Sachiko Kuno, Ph.D., founding chief executive officer and advisor, international business development, established the European operations in 2002 as part of an ongoing expansion of Sucampo Pharmaceuticals, Inc. as a global company in research and development of its drugs based on prostones. 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® (lubiprostone) in the U.S. for chronic idiopathic constipation in adults and is developing the drug for additional gastrointestinal disorders with large potential markets. In addition, the company 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.
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 commercialisation 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' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission for the quarter ended September 30, 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.
AMITIZA® is a registered trademark of Sucampo Pharmaceuticals, Inc.
Source: Sucampo Pharmaceuticals
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