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(R) 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(R) (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(R) (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(R) (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(R) is a registered trademark of Sucampo Pharmaceuticals,
Inc.
